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Excessive knee joint loads during walking can contribute to knee osteoarthritis progression. Changing the rotation of the foot (in-toeing or out-toeing) while walking can lower knee joint loads and improve pain and function. Telerehabilitation (using video or telephone communication to delivery rehabilitation) has shown promise in delivering exercise therapy for knee osteoarthritis, but it is unknown if walking modifications can be delivered using this method. This study consists of a six-week walking modification program in people with knee osteoarthritis. Performance of the modification will be measured using motion capture and wearable sensors during practice and daily life.
Loads on the knee joint during walking are related to worsening of knee osteoarthritis. Changing walking motions to lower these knee joint loads is an emerging management strategy for knee osteoarthritis. Multiple studies have targeted a change in the position of the foot relative to the direction of walking (toe-in or toe-out walking) and have shown this walking modification to lower knee joint loads and improve symptoms (e.g. pain) related to knee osteoarthritis within the context of a walking program. Building off the many studies that have found telerehabilitation to be an effective method of providing exercise and pain-coping physical therapy, the investigators will use this method to provide walking modification treatment. Telerehabilitation (using video or teleconferencing to conduct the physical therapy appointment) provides a convenient and cost-effective method to work with patients and coordinate their treatment plan. To monitor progress with learning the walking modification, the investigators will use a custom sensor shoe that the participants will wear during daily walking activities over the six-week intervention. Overall, this study will investigate the feasibility and effectiveness of a walking modification program delivered using video- or teleconference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention: Telerehabilitation | Experimental | Immediate entry into the gait modification intervention delivered using teleconferencing methods |
|
| Delayed Intervention: Telerehabilitation | Experimental | Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot rotation modification | Behavioral | The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by "as much as is comfortable". |
| Measure | Description | Time Frame |
|---|---|---|
| Lab-measured Performance of Gait Modification | Change in foot rotation angle between baseline and week 6 (follow-up) appointments measured using marker-based motion capture. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted. | Baseline, Week 6 |
| Real-world Performance of Gait Modification | Change in absolute median foot rotation from baseline to each real-world walking bout (represented as a single data file on the sensor module), follow-up, and retention measured via the sensor shoe. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted, in addition to the proportion of steps with a greater than or equal to 7 degree change. | Baseline, Week 1&2, Week 3&4, Week 5&6, Follow up (Week 6/12), Retention (Week 10/16) |
| Intervention Adherence | Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total). | Week 6 |
| Compliance With Gait Modification | Compliance will be estimated by self-reported confidence in performing the gait modification (where 0 = "no confidence" and 10 = "complete confidence") at follow up. Acceptable confidence ratings by week 6 are greater than or equal to 7/10. | Week 6 |
| Difficulty in Performing the Modification | Difficulty of performing the modification at week 6. Difficulty measured on an NRS scale (0 = no difficulty and 10 = most difficulty possible). Acceptable difficulty by week 6 is less than or equal to 4/10. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Knee-osteoarthritis Related Symptoms | Change in pain (9 items), stiffness (7 items), physical function (17 items), and quality of life (4 items) will be measured by the Knee Injury and Osteoarthritis Outcome Score at baseline, follow up and retention. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motion Analysis and Biofeedback Laboratory | Vancouver | British Columbia | V6T 1Z3 | Canada |
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Participants completed a biomechanical screen involving normal and modified walking in a motion capture space. The data were used to calculate the knee adduction moment impulse (main biomechanical outcome) and foot progression angle (modification target). Those who did not reduce their knee adduction moment impulse >5% were not included in the study.
Two recruitment drives were completed using online social media outlets between January 2021 and May 2021. The drives garnered 134 respondents (72 and 62, respectively) who were preliminarily screened for study inclusion/exclusion. Sixty individuals underwent radiographic screening and 28 underwent biomechanical screening for response to gait modification. A total of 20 participants completed baseline assessments and were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Intervention: Telerehabilitation | Immediate entry into the gait modification intervention delivered using teleconferencing methods Foot rotation modification: The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by "as much as is comfortable". |
| FG001 | Delayed Intervention: Telerehabilitation | Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods Foot rotation modification: The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by "as much as is comfortable". Waiting Period - Delayed Group: Participants allocated to the Delayed Group will wait 6 weeks after their initial baseline, then complete a second baseline to provide a control condition. After the second baseline they will enter the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Intervention: Telerehabilitation | Immediate entry into the gait modification intervention delivered using teleconferencing methods Foot rotation modification: The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by "as much as is comfortable". |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lab-measured Performance of Gait Modification | Change in foot rotation angle between baseline and week 6 (follow-up) appointments measured using marker-based motion capture. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted. | Posted | Mean | 95% Confidence Interval | degrees | Baseline, Week 6 |
|
Adverse event data were collected during the six week intervention period. For the immediate group this was Week 0 to Week 6 and for the delayed group this was Week 6 to Week 12. Adverse events were reported at each telerehabilitation appointment with the study interventionist.
Adverse event data collected by participant self-report. These measures are presented for the whole study sample as the data for the two intervention periods (immediate and delayed groups) were combined for the pre-post analysis in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delayed Intervention: Telerehabilitation | Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods Foot rotation modification: The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by "as much as is comfortable". Waiting Period - Delayed Group: Participants allocated to the Delayed Group will wait 6 weeks after their initial baseline, then complete a second baseline to provide a control condition. After the second baseline they will enter the intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip/thigh discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Hunt | University of British Columbia | 604-827-4721 | michael.hunt@ubc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2021 | Mar 4, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2021 | Mar 4, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Two-arm delayed control design
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| Waiting Period - Delayed Group | Other | Participants allocated to the Delayed Group will wait 6 weeks after their initial baseline, then complete a second baseline to provide a control condition. After the second baseline they will enter the intervention. |
|
|
| Satisfaction With the Treatment Program | Satisfaction with the gait modification program on a 7-point Likert scale where -3 = "extremely unsatisfied" and +3 = "extremely satisfied". Scores of +2 or +3 will be considered "satisfied" and acceptable. | Week 6 |
| Baseline, Week 6 |
| Knee Joint Moments | Peaks and impulse of the knee adduction moment and knee flexion moment measured via in-laboratory gait analysis (force platforms and marker-based motion capture) at baseline, and follow up. | Baseline, Week 6 |
| Knee Joint Moment Impulse | Impulse of the knee adduction and flexion moments. | Baseline, Week 6 |
| BG001 |
| Delayed Intervention: Telerehabilitation |
Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods Foot rotation modification: The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by "as much as is comfortable". Waiting Period - Delayed Group: Participants allocated to the Delayed Group will wait 6 weeks after their initial baseline, then complete a second baseline to provide a control condition. After the second baseline they will enter the intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass | Median | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Knee Symptom Laterality | Count of Participants | Participants |
|
| Symptom Duration | Mean | Standard Deviation | months |
|
| Kellgren and Lawrence Grade | The Kellgren and Lawrence grading scale was used to quantify the severity of structural signs of osteoarthritis in the knee. The scale ranges from 0 to 4 with 0 representing no signs of osteoarthritis and 4 representing severe osteoarthritis. Grading was performed by two experienced team members (over 30 years combined experience) and the final score was based on consensus. | Count of Participants | Participants |
|
| Foot Progression Angle Direction Prescription | Count of Participants | Participants |
|
Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods Foot rotation modification: The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by "as much as is comfortable". Waiting Period - Delayed Group: Participants allocated to the Delayed Group will wait 6 weeks after their initial baseline, then complete a second baseline to provide a control condition. After the second baseline they will enter the intervention. |
|
|
|
| Primary | Real-world Performance of Gait Modification | Change in absolute median foot rotation from baseline to each real-world walking bout (represented as a single data file on the sensor module), follow-up, and retention measured via the sensor shoe. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted, in addition to the proportion of steps with a greater than or equal to 7 degree change. | Posted | Mean | Standard Deviation | degrees | Baseline, Week 1&2, Week 3&4, Week 5&6, Follow up (Week 6/12), Retention (Week 10/16) |
|
|
|
|
| Primary | Intervention Adherence | Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total). | Posted | Mean | Full Range | percent of sessions attended | Week 6 |
|
|
|
| Primary | Compliance With Gait Modification | Compliance will be estimated by self-reported confidence in performing the gait modification (where 0 = "no confidence" and 10 = "complete confidence") at follow up. Acceptable confidence ratings by week 6 are greater than or equal to 7/10. | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
|
|
|
| Primary | Difficulty in Performing the Modification | Difficulty of performing the modification at week 6. Difficulty measured on an NRS scale (0 = no difficulty and 10 = most difficulty possible). Acceptable difficulty by week 6 is less than or equal to 4/10. | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
|
|
|
| Primary | Satisfaction With the Treatment Program | Satisfaction with the gait modification program on a 7-point Likert scale where -3 = "extremely unsatisfied" and +3 = "extremely satisfied". Scores of +2 or +3 will be considered "satisfied" and acceptable. | Posted | Median | Inter-Quartile Range | score on a scale | Week 6 |
|
|
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| Secondary | Knee-osteoarthritis Related Symptoms | Change in pain (9 items), stiffness (7 items), physical function (17 items), and quality of life (4 items) will be measured by the Knee Injury and Osteoarthritis Outcome Score at baseline, follow up and retention. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%. | Posted | Mean | 95% Confidence Interval | scores on a scale | Baseline, Week 6 |
|
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|
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| Secondary | Knee Joint Moments | Peaks and impulse of the knee adduction moment and knee flexion moment measured via in-laboratory gait analysis (force platforms and marker-based motion capture) at baseline, and follow up. | Posted | Mean | 95% Confidence Interval | Nm/kg | Baseline, Week 6 |
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| Secondary | Knee Joint Moment Impulse | Impulse of the knee adduction and flexion moments. | Posted | Mean | 95% Confidence Interval | Nm/kg*s | Baseline, Week 6 |
|
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 7 |
| 10 |
| EG001 | Immediate Intervention: Telerehabilitation | Immediate entry into the gait modification intervention delivered using teleconferencing methods Foot rotation modification: The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by "as much as is comfortable". | 0 | 10 | 0 | 10 | 8 | 10 |
| Knee discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Ankle/foot discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
| Kellgren and Lawrence 4 |
|
| Week 5&6 |
|
| Follow up |
|
| Retention |
|
|
The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention |
| t-test, 2 sided |
| 1.0 |
Week 3&4 vs Week 5&6 |
| Other |
| The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention | t-test, 2 sided | alpha corrected with Bonferroni-Dunn procedure (k=10). | 0.078 | Week 5&6 vs Follow up | Other |
| The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention | t-test, 2 sided | alpha corrected with Bonferroni-Dunn procedure (k=10). | 0.015 | Follow up vs Retention | Other |
| The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention | t-test, 2 sided | alpha corrected with Bonferroni-Dunn procedure (k=10). | 0.567 | Week 1&2 vs Week 5&6 | Other |
| The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention | t-test, 2 sided | alpha corrected with Bonferroni-Dunn procedure (k=10). | 0.001 | Week 1&2 vs Follow up | Other |
| The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention | t-test, 2 sided | alpha corrected with Bonferroni-Dunn procedure (k=10). | 1.0 | Week 1&2 vs Retention | Other |
| The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention | t-test, 2 sided | alpha corrected with Bonferroni-Dunn procedure (k=10). | 0.205 | Week 3&4 vs Follow up | Other |
| The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention | t-test, 2 sided | alpha corrected with Bonferroni-Dunn procedure (k=10). | 0.162 | Week 3&4 vs Retention | Other |
| The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention | t-test, 2 sided | alpha corrected with Bonferroni-Dunn procedure (k=10). | 0.421 | Week 5&6 vs Retention | Other |
| Baseline Stiffness |
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| Week 6 Stiffness |
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| Baseline Physical Function |
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| Week 6 Physical Function |
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| Baseline Quality of Life |
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| Week 6 Quality of Life |
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Knee Injury and Osteoarthritis Outcome Scale - stiffness subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.
| ANCOVA |
Controlling for baseline scores, structural severity and sex. alpha=0.05 |
| 0.201 |
| Superiority |
| Knee Injury and Osteoarthritis Outcome Scale - physical function subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA. | ANCOVA | Controlling for baseline scores, structural severity and sex. alpha=0.05 | 0.997 | Superiority |
| Knee Injury and Osteoarthritis Outcome Scale - quality of life subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA. | ANCOVA | Controlling for baseline scores, structural severity and sex. alpha=0.05 | 0.423 | Superiority |
| Baseline KAM2 |
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| Week 6 KAM2 |
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| Baseline KFM peak |
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| Week 6 KFM peak |
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| ANCOVA |
Controlling for body mass, structural severity and sex. alpha=0.05 |
| 0.844 |
| Superiority |
| Knee Flexion Moments were analyzed as raw Nm with body mass entered as as covariate | ANCOVA | Controlling for body mass, structural severity and sex. alpha=0.05 | 0.774 | Superiority |
| KFM Impulse Baseline |
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| KFM Impulse Week 6 |
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| ANCOVA |
Controlling for body mass, structural severity and sex. alpha=0.05 |
| 0.601 |
| Superiority |