Trial Outcomes & Findings for Gait Modification Treatment for Knee Osteoarthritis (NCT NCT02019108)
NCT ID: NCT02019108
Last Updated: 2019-07-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
Weeks 0, 17, 21
Results posted on
2019-07-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
|
Overall Study
Baseline (Week 0)
|
40
|
39
|
|
Overall Study
Follow-up (Week 17)
|
38
|
36
|
|
Overall Study
Retention (Week 21)
|
35
|
32
|
|
Overall Study
COMPLETED
|
35
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Gait Modification Group
n=40 Participants
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.
|
Walking Only Group
n=39 Participants
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.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 7.6 • n=40 Participants
|
65.4 years
STANDARD_DEVIATION 9.6 • n=39 Participants
|
65.0 years
STANDARD_DEVIATION 8.6 • n=79 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=40 Participants
|
28 Participants
n=39 Participants
|
55 Participants
n=79 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=40 Participants
|
11 Participants
n=39 Participants
|
24 Participants
n=79 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
40 participants
n=40 Participants
|
39 participants
n=39 Participants
|
79 participants
n=79 Participants
|
|
Body Mass Index
|
27.3 kg/m^2
STANDARD_DEVIATION 3.5 • n=40 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 3.5 • n=39 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 3.5 • n=79 Participants
|
|
Radiographic Severity
Mild (KL2)
|
19 Participants
n=40 Participants
|
18 Participants
n=39 Participants
|
37 Participants
n=79 Participants
|
|
Radiographic Severity
Moderate (KL3)
|
17 Participants
n=40 Participants
|
14 Participants
n=39 Participants
|
31 Participants
n=79 Participants
|
|
Radiographic Severity
Severe (KL4)
|
4 Participants
n=40 Participants
|
7 Participants
n=39 Participants
|
11 Participants
n=79 Participants
|
PRIMARY outcome
Timeframe: Weeks 0, 17, 21Population: 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.
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.
Outcome measures
| Measure |
Gait Modification Group
n=38 Participants
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.
|
Walking Only Group
n=36 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale
Change from Baseline to Week 17
|
-2.1 units on a scale
Interval -2.7 to -1.5
|
-1.8 units on a scale
Interval -2.4 to -1.2
|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale
Change from Baseline to Week 21
|
-2.2 units on a scale
Interval -2.8 to -1.7
|
-1.5 units on a scale
Interval -2.1 to -0.9
|
PRIMARY outcome
Timeframe: Weeks 0, 17, 21Population: 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.
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.
Outcome measures
| Measure |
Gait Modification Group
n=38 Participants
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.
|
Walking Only Group
n=36 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.
Change from Baseline to Week 17
|
-2.7 units on a scale
Interval -3.6 to -1.7
|
-1.5 units on a scale
Interval -2.5 to -0.5
|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.
Change from Baseline to Week 21
|
-2.5 units on a scale
Interval -3.5 to -1.6
|
-1.5 units on a scale
Interval -2.5 to -0.5
|
PRIMARY outcome
Timeframe: Weeks 0, 17, 21Population: 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.
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.
Outcome measures
| Measure |
Gait Modification Group
n=37 Participants
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.
|
Walking Only Group
n=33 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment
Change from Baseline to Week 17
|
-0.01 %Body Weight*Height
Interval -0.13 to 0.11
|
0.13 %Body Weight*Height
Interval 0.0 to 0.26
|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment
Change from Baseline to Week 21
|
-0.06 %Body Weight*Height
Interval -0.2 to 0.08
|
0.11 %Body Weight*Height
Interval -0.04 to 0.26
|
PRIMARY outcome
Timeframe: Weeks 0, 17, 21Population: 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.
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.
Outcome measures
| Measure |
Gait Modification Group
n=37 Participants
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.
|
Walking Only Group
n=33 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment
Change from Baseline to Week 17
|
-0.24 %Body Weight*Height
Interval -0.33 to -0.15
|
0.02 %Body Weight*Height
Interval -0.08 to 0.11
|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment
Change from Baseline to Week 21
|
-0.19 %Body Weight*Height
Interval -0.33 to -0.04
|
0.01 %Body Weight*Height
Interval -0.14 to 0.16
|
PRIMARY outcome
Timeframe: Weeks 0, 17, 21Population: 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.
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.
Outcome measures
| Measure |
Gait Modification Group
n=37 Participants
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.
|
Walking Only Group
n=33 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse
Change from Baseline to Week 17
|
-0.04 %Body Weight*Height*seconds
Interval -0.08 to -0.01
|
0.01 %Body Weight*Height*seconds
Interval -0.02 to 0.05
|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse
Change from Baseline to Week 21
|
-0.06 %Body Weight*Height*seconds
Interval -0.1 to -0.02
|
0.00 %Body Weight*Height*seconds
Interval -0.04 to 0.05
|
PRIMARY outcome
Timeframe: Weeks 0, 17, 21Population: 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.
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.
Outcome measures
| Measure |
Gait Modification Group
n=37 Participants
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.
|
Walking Only Group
n=33 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA)
Change from Baseline to Week 21
|
-6.96 degrees
Interval -8.35 to -5.58
|
-0.18 degrees
Interval -1.66 to 1.29
|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA)
Change from Baseline to Week 17
|
-8.87 degrees
Interval -10.36 to -7.39
|
0.17 degrees
Interval -1.41 to 1.74
|
SECONDARY outcome
Timeframe: Weeks 0, 17, 21Population: 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.
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.
Outcome measures
| Measure |
Gait Modification Group
n=38 Participants
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.
|
Walking Only Group
n=36 Participants
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.
|
|---|---|---|
|
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.
Change from Baseline to Week 17
|
-11.4 units on a scale
Interval -14.6 to -8.3
|
-7.7 units on a scale
Interval -10.9 to -4.5
|
|
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.
Change from Baseline to Week 21
|
-9.4 units on a scale
Interval -12.4 to -6.3
|
-6.6 units on a scale
Interval -9.8 to -3.4
|
SECONDARY outcome
Timeframe: Weeks 0, 17, 21Population: 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.
Participants were instructed to ascend 12 stairs "as quickly as possible", and the fastest time from two attempts was recorded.
Outcome measures
| Measure |
Gait Modification Group
n=37 Participants
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.
|
Walking Only Group
n=33 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb.
Change from Baseline to Week 21
|
-0.44 seconds
Interval -0.89 to 0.01
|
-0.33 seconds
Interval -0.8 to 0.14
|
|
Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb.
Change from Baseline to Week 17
|
-0.16 seconds
Interval -0.55 to 0.24
|
-0.37 seconds
Interval -0.78 to 0.05
|
SECONDARY outcome
Timeframe: Weeks 0, 17, 21Population: 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.
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.
Outcome measures
| Measure |
Gait Modification Group
n=37 Participants
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.
|
Walking Only Group
n=33 Participants
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.
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|---|---|---|
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Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment
Change from Baseline to Week 21
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0.31 %Body Weight*Height
Interval -0.01 to 0.62
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0.28 %Body Weight*Height
Interval -0.06 to 0.61
|
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Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment
Change from Baseline to Week 17
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0.06 %Body Weight*Height
Interval -0.26 to 0.38
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0.09 %Body Weight*Height
Interval -0.24 to 0.43
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Adverse Events
Gait Modification Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Walking Only Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gait Modification Group
n=40 participants at risk
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.
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Walking Only Group
n=39 participants at risk
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.
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|---|---|---|
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Musculoskeletal and connective tissue disorders
Hip Pain
|
12.5%
5/40 • Number of events 5 • 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.
|
5.1%
2/39 • Number of events 2 • 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.
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
0.00%
0/40 • 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.
|
2.6%
1/39 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
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2.5%
1/40 • Number of events 1 • 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.
|
2.6%
1/39 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Big Toe Pain
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2.5%
1/40 • Number of events 1 • 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.
|
0.00%
0/39 • 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.
|
|
Musculoskeletal and connective tissue disorders
Posterior Thigh Pain
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2.5%
1/40 • Number of events 1 • 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.
|
0.00%
0/39 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place