| Primary | University of Wisconsin Running Injury and Recovery Index Score at Baseline | The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicates better running ability. | | Posted | | Mean | Standard Deviation | cumulative score on a 9-item scale | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). | | OG003 | Supervised Gait Retraining + Botulinum Toxin Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00010.86± 5.90
- OG00111.86± 4.95
- OG00212.14± 3.44
- OG003
|
|
| |
| Primary | University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection | The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicates better running ability. | | Posted | | Mean | Standard Deviation | Cumulative Score on a 9-item scale | | 8-week | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
|
| Primary | University of Wisconsin Running Injury and Recovery Index Score at 3-months Post-injection | The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicates better running ability. | | Posted | | Mean | Standard Deviation | Cumulative score on a 9-item scale | | 3-month | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
|
| Primary | University of Wisconsin Running Injury and Recovery Index Score 6-months Post-injection | The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicate better running ability. | | Posted | | Mean | Standard Deviation | Cumulative score on a 9-item scale | | 6-month | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
|
| Primary | University of Wisconsin Running Injury and Recovery Index Score at 12-months Post-Injection | The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicate better running ability. | | Posted | | Mean | Standard Deviation | Cumulative Score on a 9-item scale | | 12-month | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
|
| Primary | University of Wisconsin Running Injury and Recovery Index Score at 24-Months Post-Injection | The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicate better running ability. | | Posted | | Mean | Standard Deviation | Cumulative Score on a 9-item scale | | 24-month | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
|
| Primary | Single Assessment Numerical Evaluation (SANE) Score at Baseline | A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Single Assessment Numerical Evaluation (SANE) 8-weeks Post-Injection | A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function. | | Posted | | Mean | Standard Deviation | score on a scale | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Single Assessment Numerical Evaluation (SANE) at 3-months Post-Injection | A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function. | | Posted | | Mean | Standard Deviation | score on a scale | | 3-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Single Assessment Numerical Evaluation (SANE) at 6-months Post-Injection | A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function. | | Posted | | Mean | Standard Deviation | score on a scale | | 6-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Single Assessment Numerical Evaluation (SANE) at 12-months Post-Injection | A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function. | | Posted | | Mean | Standard Deviation | score on a scale | | 12-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Single Assessment Numerical Evaluation (SANE) at 24-months Post-Injection | A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function. | | Posted | | Mean | Standard Deviation | score on a scale | | 24-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Global Rate of Change Score at 8-weeks Post-Injection | Global Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better. | | Posted | | Mean | Standard Deviation | score on a scale | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). |
|
| Primary | Global Rate of Change Score 3-months Post-Injection | Global Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better. | | Posted | | Mean | Standard Deviation | score on a scale | | 3-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). |
|
| Primary | Global Rate of Change Score at 6-months Post-Injection | Global Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better. | | Posted | | Mean | Standard Deviation | score on a scale | | 6-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). |
|
| Primary | Global Rate of Change Score 12-months Post-Injection | Global Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better. | | Posted | | Mean | Standard Deviation | score on a scale | | 12-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). |
|
| Primary | Global Rate of Change Score at 24-months Post-Injection | Global Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better. | | Posted | | Mean | Standard Deviation | score on a scale | | 24-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). |
|
| Primary | Duty Status at Baseline | Question asked to military service members about their current duty status. | | Posted | | Count of Participants | | Participants | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Duty Status at 8-weeks Post-Injection | Question asked to military service members about their current duty status. | | Posted | | Count of Participants | | Participants | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Duty Status at 3-months Post-Injection | Question asked to military service members about their current duty status. | | Posted | | Count of Participants | | Participants | | 3-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Duty Status at 6-months Post-Injection | Question asked to military service members about their current duty status. | | Posted | | Count of Participants | | Participants | | 6-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Duty Status at 12-months Post-Injection | Question asked to military service members about their current duty status. | | Posted | | Count of Participants | | Participants | | 12-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Duty Status at 24-months Post-Injection | Question asked to military service members about their current duty status. | | Posted | | Count of Participants | | Participants | | 24-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
|
| Primary | Patient Specific Functional Scale Scores at Baseline | Individuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Primary | Patient Specific Functional Scale Scores at 8-weeks Post-Injection | Individuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities. | | Posted | | Mean | Standard Deviation | score on a scale | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Primary | Patient Specific Functional Scale Scores at 3-months Post-Injection | Individuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities. | | Posted | | Mean | Standard Deviation | score on a scale | | 3-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Primary | Patient Specific Functional Scale Scores at 6-months Post-Injection | Individuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities. | | Posted | | Mean | Standard Deviation | score on a scale | | 6-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Primary | Patient Specific Functional Scale Scores at 12-months Post-Injection | Individuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities. | | Posted | | Mean | Standard Deviation | score on a scale | | 12-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Primary | Patient Specific Functional Scale Scores at 24-months Post-Injection | Individuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition. The reported values represent an average across all activities. | No participants in the HBGR+Saline Injection recorded their PSFS response. | Posted | | Mean | Standard Deviation | score on a scale | | 24-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection |
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| Primary | Balance Error Scoring System Score at Baseline | The Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Primary | Balance Error Scoring System Score at 8-weeks Post-Injection | The Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance. | | Posted | | Mean | Standard Deviation | score on a scale | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Primary | Balance Error Scoring System Score at 3-months Post-Injection | The Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance. | | Posted | | Mean | Standard Deviation | score on a scale | | 3-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Primary | Balance Error Scoring System Score at 6-months Post-Injection | The Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance. | | Posted | | Mean | Standard Deviation | score on a scale | | 6-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Primary | Balance Error Scoring System Score at 12-months Post-Injection | The Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance. | | Posted | | Mean | Standard Deviation | score on a scale | | 12-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Primary | Gait Analysis - Cadence at Baseline | Using wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods. | | Posted | | Mean | Standard Deviation | steps per minute | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection |
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| Primary | Ability to Run 2 Miles at Baseline | Question asked to military service members about their ability to run 2 miles. | | Posted | | Count of Participants | | Participants | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Primary | Ability to Run 2 Miles at 8-weeks Post-Injection | Question asked to military service members about their ability to run 2 miles. | | Posted | | Count of Participants | | Participants | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Primary | Ability to Run 2 Miles at 3-months Post-Injection | Question asked to military service members about their ability to run 2 miles. | | Posted | | Count of Participants | | Participants | | 3-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Primary | Ability to Run 2 Miles at 6-months Post-Injection | Question asked to military service members about their ability to run 2 miles. | | Posted | | Count of Participants | | Participants | | 6-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Primary | Ability to Run 2 Miles at 12-months Post-Injection | Question asked to military service members about their ability to run 2 miles. | | Posted | | Count of Participants | | Participants | | 12-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Primary | Ability to Run 2 Miles at 24-months Post-Injection | Question asked to military service members about their ability to run 2 miles. | | Posted | | Count of Participants | | Participants | | 24-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Ability to Perform Service Specific Job Tasks at Baseline | Question that asks the military service member of their ability to perform service specific job tasks. | | Posted | | Count of Participants | | Participants | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection | Question that asks the military service member of their ability to perform service specific job tasks. | | Posted | | Count of Participants | | Participants | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Ability to Perform Service Specific Job Tasks at 3-months Post-Injection | Question that asks the military service member of their ability to perform service specific job tasks. | | Posted | | Count of Participants | | Participants | | 3-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Ability to Perform Service Specific Job Tasks at 6-months Post-Injection | Question that asks the military service member of their ability to perform service specific job tasks. | | Posted | | Count of Participants | | Participants | | 6-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Ability to Perform Service Specific Job Tasks at 12-months Post-Injection | Question that asks the military service member of their ability to perform service specific job tasks. | | Posted | | Count of Participants | | Participants | | 12-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Ability to Perform Service Specific Job Tasks at 24-months Post-Injection | Question that asks the military service member of their ability to perform service specific job tasks. | | Posted | | Count of Participants | | Participants | | 24-months | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Pain Running 2 Miles at Baseline | Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Secondary | Pain Running 2 Miles at 8-weeks Post-Injection | Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain | | Posted | | Mean | Standard Deviation | score on a scale | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Secondary | Pain Running 2 Miles at 3-months Post-Injection | Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain. | | Posted | | Mean | Standard Deviation | score on a scale | | 3-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Secondary | Pain Running 2 Miles at 6-months Post-Injection | Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain. | | Posted | | Mean | Standard Deviation | score on a scale | | 6-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Secondary | Pain Running 2 Miles at 12-months Post-Injection | Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain. | | Posted | | Mean | Standard Deviation | score on a scale | | 12-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Secondary | Pain Running 2 Miles at 24-months Post-Injection | Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain. | No participant in the SGR+Saline group provided 24-month data. | Posted | | Mean | Standard Deviation | score on a scale | | 24-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection |
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| Secondary | Patient Satisfaction of Treatment at 8-week Post-Injection | Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor. | | Posted | | Count of Participants | | Participants | | 8-weeks | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Patient Satisfaction of Treatment at 3-months Post-Injection | Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor. | | Posted | | Count of Participants | | Participants | | 3-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Patient Satisfaction of Treatment at 6-months Post-Injection | Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor. | | Posted | | Count of Participants | | Participants | | 6-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Patient Satisfaction of Treatment at 12-weeks Post-Injection | Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor. | | Posted | | Count of Participants | | Participants | | 12-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). |
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| Secondary | Patient Satisfaction of Treatment at 24-months Post-Injection | Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor. | No participant in the HBGR + Saline group gave 24-month response. | Posted | | Count of Participants | | Participants | | 24-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection | |
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| Primary | Gait Analysis - Cadence at 8-weeks Post-Injection | Using wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods. | | Posted | | Mean | Standard Deviation | steps per minute | | 8-Weeks | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Home Based Gait Retraining + Botulinum Toxin Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Botulinum Toxin Injection: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s). | | OG002 | Supervised Gait Retraining + Saline Injection |
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| Primary | Gait Analysis - Cadence at 3-months Post-Injection | Using wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods. | | Posted | | Mean | Standard Deviation | steps per minute | | 3-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection |
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| Primary | Gait Analysis - Cadence at 6-months Post-Injection | Using wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods. | | Posted | | Mean | Standard Deviation | steps per minute | | 6-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection |
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| Primary | Gait Analysis - Cadence at 12-months Post-Injection | Using wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods. | | Posted | | Mean | Standard Deviation | steps per minute | | 12-months | | | | ID | Title | Description |
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| OG000 | Home Based Gait Retraining + Saline Injection | Home Based Gait Retraining: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG001 | Supervised Gait Retraining + Saline Injection | Supervised Gait Retraining: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program. Saline Injection: The participant will receive a saline injection to their painful lower leg compartment(s). | | OG002 | Home Based Gait Retraining + Botulinum Toxin Injection |
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