Trial Outcomes & Findings for Telerehabilitation Gait Modification (NCT NCT04683913)
NCT ID: NCT04683913
Last Updated: 2024-12-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2024-12-04
Participant Flow
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.
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.
Participant milestones
| Measure |
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".
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
Baseline
|
10
|
10
|
|
Overall Study
Follow up
|
10
|
10
|
|
Overall Study
Secondary Baseline
|
0
|
10
|
|
Overall Study
Retention
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Immediate Intervention: Telerehabilitation
n=10 Participants
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".
|
Delayed Intervention: Telerehabilitation
n=10 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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 7.2 • n=10 Participants
|
67.9 years
STANDARD_DEVIATION 3.2 • n=10 Participants
|
67.4 years
STANDARD_DEVIATION 5.5 • n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
17 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=20 Participants
|
|
Height
|
167.3 cm
STANDARD_DEVIATION 9.6 • n=10 Participants
|
169.3 cm
STANDARD_DEVIATION 9.1 • n=10 Participants
|
168.3 cm
STANDARD_DEVIATION 9.1 • n=20 Participants
|
|
Body Mass
|
75.7 kg
STANDARD_DEVIATION 18.1 • n=10 Participants
|
75.2 kg
STANDARD_DEVIATION 11.7 • n=10 Participants
|
75.4 kg
STANDARD_DEVIATION 14.9 • n=20 Participants
|
|
Body Mass Index
|
26.8 kg/m^2
STANDARD_DEVIATION 4.7 • n=10 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 3.8 • n=10 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 4.2 • n=20 Participants
|
|
Knee Symptom Laterality
Bilateral
|
9 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
|
Knee Symptom Laterality
Unilateral
|
1 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Symptom Duration
|
114.3 months
STANDARD_DEVIATION 72.0 • n=10 Participants
|
80.2 months
STANDARD_DEVIATION 78.3 • n=10 Participants
|
97.2 months
STANDARD_DEVIATION 75.2 • n=20 Participants
|
|
Kellgren and Lawrence Grade
Kellgren and Lawrence 2
|
4 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
|
Kellgren and Lawrence Grade
Kellgren and Lawrence 3
|
3 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
|
Kellgren and Lawrence Grade
Kellgren and Lawrence 4
|
3 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Foot Progression Angle Direction Prescription
Toe-in
|
6 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=20 Participants
|
|
Foot Progression Angle Direction Prescription
Toe-out
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Change 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.
Outcome measures
| Measure |
Immediate Intervention: Telerehabilitation
n=10 Participants
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".
|
Delayed Intervention: Telerehabilitation
n=10 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.
|
|---|---|---|
|
Lab-measured Performance of Gait Modification
Baseline
|
6.32 degrees
Interval 4.25 to 8.4
|
5.71 degrees
Interval 3.03 to 8.39
|
|
Lab-measured Performance of Gait Modification
Week 6
|
11.22 degrees
Interval 7.0 to 15.43
|
5.64 degrees
Interval 2.9 to 8.38
|
PRIMARY outcome
Timeframe: Baseline, Week 1&2, Week 3&4, Week 5&6, Follow up (Week 6/12), Retention (Week 10/16)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.
Outcome measures
| Measure |
Immediate Intervention: Telerehabilitation
n=10 Participants
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".
|
Delayed Intervention: Telerehabilitation
n=10 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.
|
|---|---|---|
|
Real-world Performance of Gait Modification
Week 1&2
|
8.0 degrees
Standard Deviation 7.1
|
5.3 degrees
Standard Deviation 3.9
|
|
Real-world Performance of Gait Modification
Week 3&4
|
10.8 degrees
Standard Deviation 6.7
|
9.26 degrees
Standard Deviation 3.4
|
|
Real-world Performance of Gait Modification
Week 5&6
|
12.0 degrees
Standard Deviation 6.6
|
7.7 degrees
Standard Deviation 4.4
|
|
Real-world Performance of Gait Modification
Follow up
|
11.9 degrees
Standard Deviation 6.6
|
10.9 degrees
Standard Deviation 4.6
|
|
Real-world Performance of Gait Modification
Retention
|
5.9 degrees
Standard Deviation 3.2
|
9.73 degrees
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: Week 6Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total).
Outcome measures
| Measure |
Immediate Intervention: Telerehabilitation
n=10 Participants
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".
|
Delayed Intervention: Telerehabilitation
n=10 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.
|
|---|---|---|
|
Intervention Adherence
|
100 percent of sessions attended
Interval 100.0 to 100.0
|
100 percent of sessions attended
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: Week 6Compliance 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.
Outcome measures
| Measure |
Immediate Intervention: Telerehabilitation
n=10 Participants
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".
|
Delayed Intervention: Telerehabilitation
n=10 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.
|
|---|---|---|
|
Compliance With Gait Modification
|
8.7 score on a scale
Standard Deviation 1.3
|
8.4 score on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Week 6Difficulty 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.
Outcome measures
| Measure |
Immediate Intervention: Telerehabilitation
n=10 Participants
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".
|
Delayed Intervention: Telerehabilitation
n=10 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.
|
|---|---|---|
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Difficulty in Performing the Modification
|
1.9 score on a scale
Standard Deviation 1.7
|
2.0 score on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Week 6Satisfaction 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.
Outcome measures
| Measure |
Immediate Intervention: Telerehabilitation
n=10 Participants
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".
|
Delayed Intervention: Telerehabilitation
n=10 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.
|
|---|---|---|
|
Satisfaction With the Treatment Program
|
2.5 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline, Week 6Change 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%.
Outcome measures
| Measure |
Immediate Intervention: Telerehabilitation
n=10 Participants
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".
|
Delayed Intervention: Telerehabilitation
n=10 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.
|
|---|---|---|
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Knee-osteoarthritis Related Symptoms
Baseline Stiffness
|
55.0 scores on a scale
Interval 43.9 to 66.1
|
60.7 scores on a scale
Interval 49.1 to 72.3
|
|
Knee-osteoarthritis Related Symptoms
Baseline Physical Function
|
65.9 scores on a scale
Interval 53.1 to 78.6
|
72.9 scores on a scale
Interval 63.8 to 82.1
|
|
Knee-osteoarthritis Related Symptoms
Week 6 Quality of Life
|
47.0 scores on a scale
Interval 37.3 to 56.7
|
48.5 scores on a scale
Interval 33.1 to 63.9
|
|
Knee-osteoarthritis Related Symptoms
Baseline Pain
|
60.6 scores on a scale
Interval 50.2 to 70.9
|
59.2 scores on a scale
Interval 51.1 to 67.2
|
|
Knee-osteoarthritis Related Symptoms
Week 6 Pain
|
65.0 scores on a scale
Interval 57.1 to 72.9
|
61.9 scores on a scale
Interval 54.9 to 69.0
|
|
Knee-osteoarthritis Related Symptoms
Week 6 Stiffness
|
65.0 scores on a scale
Interval 57.1 to 72.9
|
61.4 scores on a scale
Interval 52.0 to 70.8
|
|
Knee-osteoarthritis Related Symptoms
Week 6 Physical Function
|
74.3 scores on a scale
Interval 66.7 to 81.8
|
77.6 scores on a scale
Interval 68.5 to 86.8
|
|
Knee-osteoarthritis Related Symptoms
Baseline Quality of Life
|
41.0 scores on a scale
Interval 26.6 to 55.4
|
42.0 scores on a scale
Interval 28.8 to 55.2
|
SECONDARY outcome
Timeframe: Baseline, Week 6Peaks 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.
Outcome measures
| Measure |
Immediate Intervention: Telerehabilitation
n=10 Participants
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".
|
Delayed Intervention: Telerehabilitation
n=10 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.
|
|---|---|---|
|
Knee Joint Moments
Baseline KAM1
|
0.56 Nm/kg
Interval 0.42 to 0.7
|
0.50 Nm/kg
Interval 0.39 to 0.6
|
|
Knee Joint Moments
Week 6 KAM1
|
0.49 Nm/kg
Interval 0.35 to 0.62
|
0.45 Nm/kg
Interval 0.36 to 0.53
|
|
Knee Joint Moments
Baseline KAM2
|
0.30 Nm/kg
Interval 0.22 to 0.37
|
0.33 Nm/kg
Interval 0.24 to 0.41
|
|
Knee Joint Moments
Week 6 KAM2
|
0.28 Nm/kg
Interval 0.18 to 0.38
|
0.32 Nm/kg
Interval 0.24 to 0.4
|
|
Knee Joint Moments
Baseline KFM peak
|
0.70 Nm/kg
Interval 0.58 to 0.81
|
0.66 Nm/kg
Interval 0.51 to 0.82
|
|
Knee Joint Moments
Week 6 KFM peak
|
0.72 Nm/kg
Interval 0.63 to 0.8
|
0.68 Nm/kg
Interval 0.53 to 0.83
|
SECONDARY outcome
Timeframe: Baseline, Week 6Impulse of the knee adduction and flexion moments.
Outcome measures
| Measure |
Immediate Intervention: Telerehabilitation
n=10 Participants
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".
|
Delayed Intervention: Telerehabilitation
n=10 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.
|
|---|---|---|
|
Knee Joint Moment Impulse
KAM Impulse Baseline
|
0.16 Nm/kg*s
Interval 0.12 to 0.2
|
0.18 Nm/kg*s
Interval 0.14 to 0.22
|
|
Knee Joint Moment Impulse
KAM Impulse Week 6
|
0.15 Nm/kg*s
Interval 0.11 to 0.18
|
0.17 Nm/kg*s
Interval 0.11 to 0.18
|
|
Knee Joint Moment Impulse
KFM Impulse Baseline
|
0.1 Nm/kg*s
Interval 0.08 to 0.12
|
0.13 Nm/kg*s
Interval 0.07 to 0.19
|
|
Knee Joint Moment Impulse
KFM Impulse Week 6
|
0.11 Nm/kg*s
Interval 0.09 to 0.12
|
0.13 Nm/kg*s
Interval 0.07 to 0.19
|
Adverse Events
Delayed Intervention: Telerehabilitation
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Immediate Intervention: Telerehabilitation
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Delayed Intervention: Telerehabilitation
n=10 participants at risk
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.
|
Immediate Intervention: Telerehabilitation
n=10 participants at risk
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".
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hip/thigh discomfort
|
60.0%
6/10 • Number of events 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.
|
50.0%
5/10 • Number of events 5 • 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.
|
|
Musculoskeletal and connective tissue disorders
Knee discomfort
|
20.0%
2/10 • Number of events 3 • 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.
|
20.0%
2/10 • Number of events 2 • 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.
|
|
Musculoskeletal and connective tissue disorders
Ankle/foot discomfort
|
10.0%
1/10 • Number of events 1 • 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.
|
50.0%
5/10 • Number of events 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place