Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SOG-13-024 | Other Grant/Funding Number | The Arthritis Society (Canada) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Melbourne | OTHER |
| Arthritis Research Centre of Canada | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Knee osteoarthritis (OA) is a costly health condition affecting more than 10% of Canadian adults. Excessive and unbalanced loads passing through the knee joint have been implicated in the progression of OA. Typical conservative treatment of OA has focused on increasing daily activity, without consideration for the underlying joint loading. This study aims to compare a 4-month walking program that aims to increase the angle of the foot (toe-out angle) during walking - a measure shown to reduce joint loading and OA disease progression - while increasing walking time/distance, with a standard walking program that aims to increase walking time/distance. It is predicted that the walking program focusing on increasing toe-out will provide greater reductions in self-reported knee pain and a greater reduction in unfavorable knee joint loading.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gait Modification Group | Experimental | Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait, with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well. |
|
| Walking Only Group | Active Comparator | Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive walking program with toe-out gait modification | Other | Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale | Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = maximum pain). Higher scores mean a worse outcome. Change was calculated as the value at 17 weeks and at 21 weeks minus the value at baseline. | Weeks 0, 17, 21 |
| Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale. | Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. Minimum value of the WOMAC pain subscale is 0 and maximum value is 20. Higher scores mean a worse outcome. | Weeks 0, 17, 21 |
| Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment | Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed. | Weeks 0, 17, 21 |
| Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment | Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 17 and From Baseline to Week 21 in Self-reported Physical Function as Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale. | Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. The WOMAC physical function subscale minimum value is 0 and maximum value is 68. Higher scores mean a worse outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael A Hunt, PT, PhD | The University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motion Analysis and Biofeedback Laboratory, The University of British Columbia | Vancouver | British Columbia | V6T 1Z3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29709498 | Derived | Hunt MA, Charlton JM, Krowchuk NM, Tse CTF, Hatfield GL. Clinical and biomechanical changes following a 4-month toe-out gait modification program for people with medial knee osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2018 Jul;26(7):903-911. doi: 10.1016/j.joca.2018.04.010. Epub 2018 Apr 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gait Modification Group | Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well. Progressive walking program with toe-out gait modification: Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group. |
| FG001 | Walking Only Group | Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well. Progressive walking program: At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gait Modification Group | Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well. Progressive walking program with toe-out gait modification: Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group. |
| 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 | Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale | Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = maximum pain). Higher scores mean a worse outcome. Change was calculated as the value at 17 weeks and at 21 weeks minus the value at baseline. | Participants lost to follow-up. Gait modification group lost 2 participants by week 17 and 3 additional participants by week 21 making a total loss of 5. Walking Only group lost 3 participants by week 17 and 4 additional participants by week 21 making a total loss of 7. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Weeks 0, 17, 21 |
|
Adverse event data were collected during weeks 1 - 16 by diary entry and at each visit (Weeks 1, 2, 4, 6, 8, 10, 12 and 15) with the study trainer.
Adverse event data collected by participant self-report.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gait Modification Group | Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well. Progressive walking program with toe-out gait modification: Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Hunt | University of British Columbia | 604-827-4721 | michael.hunt@ubc.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2013 | Dec 10, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Progressive walking program | Other | At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity. |
|
| Weeks 0, 17, 21 |
| Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse | Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed. | Weeks 0, 17, 21 |
| Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA) | FPA indicates orientation of the foot with respect to the forward progression of the body. Positive values correspond to a toe-in orientation, whereas negative values correspond to a toe-out orientation. Therefore, a positive change value indicates more toe-in versus a negative change value indicates more toe-out. | Weeks 0, 17, 21 |
| Weeks 0, 17, 21 |
| Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb. | Participants were instructed to ascend 12 stairs "as quickly as possible", and the fastest time from two attempts was recorded. | Weeks 0, 17, 21 |
| Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment | Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed. | Weeks 0, 17, 21 |
| BG001 | Walking Only Group | Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well. Progressive walking program: At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity. |
| 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 |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Radiographic Severity | Kellgren and Lawrence grading criteria for mild (grade 2), moderate (grade 3), and severe (grade 4) radiographic osteoarthritis. | Count of Participants | Participants |
|
| OG001 | Walking Only Group | Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well. Progressive walking program: At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity. |
|
|
|
| Primary | Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale. | Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. Minimum value of the WOMAC pain subscale is 0 and maximum value is 20. Higher scores mean a worse outcome. | Participants lost to follow-up. Gait modification group lost 2 participants by week 17 and 3 additional participants by week 21 making a total loss of 5. Walking Only group lost 3 participants by week 17 and 4 additional participants by week 21 making a total loss of 7. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Weeks 0, 17, 21 |
|
|
|
|
| Primary | Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment | Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed. | Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8. | Posted | Least Squares Mean | 95% Confidence Interval | %Body Weight*Height | Weeks 0, 17, 21 |
|
|
|
|
| Primary | Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment | Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed. | Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8. | Posted | Least Squares Mean | 95% Confidence Interval | %Body Weight*Height | Weeks 0, 17, 21 |
|
|
|
|
| Primary | Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse | Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed. | Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8. | Posted | Least Squares Mean | 95% Confidence Interval | %Body Weight*Height*seconds | Weeks 0, 17, 21 |
|
|
|
|
| Primary | Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA) | FPA indicates orientation of the foot with respect to the forward progression of the body. Positive values correspond to a toe-in orientation, whereas negative values correspond to a toe-out orientation. Therefore, a positive change value indicates more toe-in versus a negative change value indicates more toe-out. | Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8. | Posted | Least Squares Mean | 95% Confidence Interval | degrees | Weeks 0, 17, 21 |
|
|
|
|
| Secondary | Change From Baseline to Week 17 and From Baseline to Week 21 in Self-reported Physical Function as Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale. | Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. The WOMAC physical function subscale minimum value is 0 and maximum value is 68. Higher scores mean a worse outcome. | Participants lost to follow-up. Gait modification group lost 2 participants by week 17 and 3 additional participants by week 21 making a total loss of 5. Walking Only group lost 3 participants by week 17 and 4 additional participants by week 21 making a total loss of 7. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Weeks 0, 17, 21 |
|
|
|
|
| Secondary | Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb. | Participants were instructed to ascend 12 stairs "as quickly as possible", and the fastest time from two attempts was recorded. | Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8. | Posted | Least Squares Mean | 95% Confidence Interval | seconds | Weeks 0, 17, 21 |
|
|
|
|
| Secondary | Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment | Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed. | Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8. | Posted | Least Squares Mean | 95% Confidence Interval | %Body Weight*Height | Weeks 0, 17, 21 |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 8 |
| 40 |
| EG001 | Walking Only Group | Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well. Progressive walking program: At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity. | 0 | 39 | 0 | 39 | 4 | 39 |
| Foot Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lower Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Big Toe Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Posterior Thigh Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Severe (KL4) |
|
| Change from Baseline to Week 21 |
|
|
This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks. |
| ANCOVA |
Controlling for baseline values. |
| 0.133 |
a priori threshold for statistical significance <0.05 |
| Mean Difference (Final Values) |
| -1.1 |
| 2-Sided |
| 95 |
| -2.5 |
| 0.3 |
| Superiority |
| Change from Baseline to Week 21 |
|
|
This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks |
| ANCOVA |
Controlling for baseline values and walking speed. |
| 0.103 |
a priori threshold for statistical significance <0.05 |
| Mean Difference (Final Values) |
| -0.17 |
| 2-Sided |
| 95 |
| -0.37 |
| 0.03 |
| Superiority |
| Change from Baseline to Week 21 |
|
|
This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks. |
| ANCOVA |
Controlling for baseline values and walking speed. |
| 0.056 |
a priori threshold for statistical significance <0.05 |
| Mean Difference (Final Values) |
| -0.20 |
| 2-Sided |
| 95 |
| -0.40 |
| 0.01 |
| Superiority |
| Change from Baseline to Week 21 |
|
|
This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks. |
| ANCOVA |
Controlling for baseline values and walking speed. |
| 0.058 |
a priori threshold for statistical significance <0.05 |
| Mean Difference (Final Values) |
| -0.06 |
| 2-Sided |
| 95 |
| -0.12 |
| 0.00 |
| Superiority |
| Change from Baseline to Week 21 |
|
|
This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks. |
| ANCOVA |
Controlling for baseline values and walking speed. |
| <0.001 |
a priori threshold for statistical significance <0.05. |
| Mean Difference (Final Values) |
| -6.78 |
| 2-Sided |
| 95 |
| -8.82 |
| -4.75 |
| Superiority |
| Change from Baseline to Week 21 |
|
|
This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks. |
| ANCOVA |
Controlling for baseline values. |
| 0.232 |
a priori threshold for statistical significance <0.05. |
| Mean Difference (Final Values) |
| -2.7 |
| 2-Sided |
| 95 |
| -7.3 |
| 1.8 |
| Superiority |
| Change from Baseline to Week 21 |
|
|
This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks. |
| ANCOVA |
Controlling for baseline values. |
| 0.737 |
a priori threshold for statistical significance <0.05. |
| Mean Difference (Final Values) |
| -0.11 |
| 2-Sided |
| 95 |
| -0.76 |
| 0.54 |
| Superiority |
| Change from Baseline to Week 21 |
|
|
This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks. |
| ANCOVA |
Controlling for baseline values and walking speed. |
| 0.897 |
a priori threshold for statistical significance <0.05 |
| Mean Difference (Final Values) |
| 0.03 |
| 2-Sided |
| 95 |
| -0.43 |
| 0.49 |
| Superiority |