Osteoarthritis, Knee
Conditions
Keywords
Gait Modification, Wearable Sensors, Real-world Monitoring, Telerehabilitation
Brief summary
Excessive knee joint loads during walking can contribute to knee osteoarthritis progression. Changing the rotation of the foot (in-toeing or out-toeing) while walking can lower knee joint loads and improve pain and function. Telerehabilitation (using video or telephone communication to delivery rehabilitation) has shown promise in delivering exercise therapy for knee osteoarthritis, but it is unknown if walking modifications can be delivered using this method. This study consists of a six-week walking modification program in people with knee osteoarthritis. Performance of the modification will be measured using motion capture and wearable sensors during practice and daily life.
Detailed description
Loads on the knee joint during walking are related to worsening of knee osteoarthritis. Changing walking motions to lower these knee joint loads is an emerging management strategy for knee osteoarthritis. Multiple studies have targeted a change in the position of the foot relative to the direction of walking (toe-in or toe-out walking) and have shown this walking modification to lower knee joint loads and improve symptoms (e.g. pain) related to knee osteoarthritis within the context of a walking program. Building off the many studies that have found telerehabilitation to be an effective method of providing exercise and pain-coping physical therapy, the investigators will use this method to provide walking modification treatment. Telerehabilitation (using video or teleconferencing to conduct the physical therapy appointment) provides a convenient and cost-effective method to work with patients and coordinate their treatment plan. To monitor progress with learning the walking modification, the investigators will use a custom sensor shoe that the participants will wear during daily walking activities over the six-week intervention. Overall, this study will investigate the feasibility and effectiveness of a walking modification program delivered using video- or teleconference.
Interventions
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.
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.
Sponsors
Study design
Intervention model description
Two-arm delayed control design
Eligibility
Inclusion criteria
* 50 years of age or older * Exhibit signs of tibiofemoral osteoarthritis based on a score of ≥2 on the Kellgren and Lawrence grading scale predominantly in the medial compartment. * Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = no pain and 10 = worst pain imaginable) during most days of the previous month * Comfortable walking intermittently for 30 minutes * Fit into the available sizes of sensor shoes (between US women's 5 to men's 13) * Exhibits ≥2% reduction in knee adduction moment impulse at 10 degrees of change in toe-in or toe-out during the screening appointment.
Exclusion criteria
* Any knee surgery or intraarticular injections within the past 6 months * A history of joint replacement surgery or high tibial osteotomy * Current or recent (within 6 weeks) corticosteroid injections * Use of a gait aid * Currently on a wait list for joint replacement surgery or high tibial osteotomy * Any inflammatory arthritic condition * Any other conditions that may affect normal gait or participation in an aerobic exercise program * Cannot attend all required appointments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With the Treatment Program | Week 6 | Satisfaction with the gait modification program on a 7-point Likert scale where -3 = extremely unsatisfied and +3 = extremely satisfied. Scores of +2 or +3 will be considered satisfied and acceptable. |
| Intervention Adherence | Week 6 | Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total). |
| Compliance With Gait Modification | Week 6 | Compliance will be estimated by self-reported confidence in performing the gait modification (where 0 = no confidence and 10 = complete confidence) at follow up. Acceptable confidence ratings by week 6 are greater than or equal to 7/10. |
| Difficulty in Performing the Modification | Week 6 | Difficulty of performing the modification at week 6. Difficulty measured on an NRS scale (0 = no difficulty and 10 = most difficulty possible). Acceptable difficulty by week 6 is less than or equal to 4/10. |
| Lab-measured Performance of Gait Modification | Baseline, Week 6 | 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. |
| Real-world Performance of Gait Modification | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Joint Moments | Baseline, Week 6 | Peaks and impulse of the knee adduction moment and knee flexion moment measured via in-laboratory gait analysis (force platforms and marker-based motion capture) at baseline, and follow up. |
| Knee Joint Moment Impulse | Baseline, Week 6 | Impulse of the knee adduction and flexion moments. |
| Knee-osteoarthritis Related Symptoms | Baseline, Week 6 | Change in pain (9 items), stiffness (7 items), physical function (17 items), and quality of life (4 items) will be measured by the Knee Injury and Osteoarthritis Outcome Score at baseline, follow up and retention. Each item is rated on a 5 points Likert scale where 0 = No problems and 4 = Extreme Problems. Higher scores indicate better function. The scores are normalized to 0-100%. |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | Delayed Intervention: Telerehabilitation | Immediate Intervention: Telerehabilitation |
|---|---|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 5.5 | 67.9 years STANDARD_DEVIATION 3.2 | 66.8 years STANDARD_DEVIATION 7.2 |
| Body Mass | 75.4 kg STANDARD_DEVIATION 14.9 | 75.2 kg STANDARD_DEVIATION 11.7 | 75.7 kg STANDARD_DEVIATION 18.1 |
| Body Mass Index | 26.5 kg/m^2 STANDARD_DEVIATION 4.2 | 26.2 kg/m^2 STANDARD_DEVIATION 3.8 | 26.8 kg/m^2 STANDARD_DEVIATION 4.7 |
| Foot Progression Angle Direction Prescription Toe-in | 11 Participants | 5 Participants | 6 Participants |
| Foot Progression Angle Direction Prescription Toe-out | 9 Participants | 5 Participants | 4 Participants |
| Height | 168.3 cm STANDARD_DEVIATION 9.1 | 169.3 cm STANDARD_DEVIATION 9.1 | 167.3 cm STANDARD_DEVIATION 9.6 |
| Kellgren and Lawrence Grade Kellgren and Lawrence 2 | 7 Participants | 3 Participants | 4 Participants |
| Kellgren and Lawrence Grade Kellgren and Lawrence 3 | 7 Participants | 4 Participants | 3 Participants |
| Kellgren and Lawrence Grade Kellgren and Lawrence 4 | 6 Participants | 3 Participants | 3 Participants |
| Knee Symptom Laterality Bilateral | 14 Participants | 5 Participants | 9 Participants |
| Knee Symptom Laterality Unilateral | 6 Participants | 5 Participants | 1 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Canada | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 17 Participants | 8 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 1 Participants |
| Symptom Duration | 97.2 months STANDARD_DEVIATION 75.2 | 80.2 months STANDARD_DEVIATION 78.3 | 114.3 months STANDARD_DEVIATION 72 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 7 / 10 | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Compliance With Gait Modification
Compliance will be estimated by self-reported confidence in performing the gait modification (where 0 = no confidence and 10 = complete confidence) at follow up. Acceptable confidence ratings by week 6 are greater than or equal to 7/10.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention: Telerehabilitation | Compliance With Gait Modification | 8.7 score on a scale | Standard Deviation 1.3 |
| Delayed Intervention: Telerehabilitation | Compliance With Gait Modification | 8.4 score on a scale | Standard Deviation 1.3 |
Difficulty in Performing the Modification
Difficulty of performing the modification at week 6. Difficulty measured on an NRS scale (0 = no difficulty and 10 = most difficulty possible). Acceptable difficulty by week 6 is less than or equal to 4/10.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention: Telerehabilitation | Difficulty in Performing the Modification | 1.9 score on a scale | Standard Deviation 1.7 |
| Delayed Intervention: Telerehabilitation | Difficulty in Performing the Modification | 2.0 score on a scale | Standard Deviation 1.6 |
Intervention Adherence
Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total).
Time frame: Week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Immediate Intervention: Telerehabilitation | Intervention Adherence | 100 percent of sessions attended |
| Delayed Intervention: Telerehabilitation | Intervention Adherence | 100 percent of sessions attended |
Lab-measured Performance of Gait Modification
Change in foot rotation angle between baseline and week 6 (follow-up) appointments measured using marker-based motion capture. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted.
Time frame: Baseline, Week 6
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Intervention: Telerehabilitation | Lab-measured Performance of Gait Modification | Baseline | 6.32 degrees |
| Immediate Intervention: Telerehabilitation | Lab-measured Performance of Gait Modification | Week 6 | 11.22 degrees |
| Delayed Intervention: Telerehabilitation | Lab-measured Performance of Gait Modification | Baseline | 5.71 degrees |
| Delayed Intervention: Telerehabilitation | Lab-measured Performance of Gait Modification | Week 6 | 5.64 degrees |
Real-world Performance of Gait Modification
Change in absolute median foot rotation from baseline to each real-world walking bout (represented as a single data file on the sensor module), follow-up, and retention measured via the sensor shoe. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted, in addition to the proportion of steps with a greater than or equal to 7 degree change.
Time frame: Baseline, Week 1&2, Week 3&4, Week 5&6, Follow up (Week 6/12), Retention (Week 10/16)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention: Telerehabilitation | Real-world Performance of Gait Modification | Follow up | 11.9 degrees | Standard Deviation 6.6 |
| Immediate Intervention: Telerehabilitation | Real-world Performance of Gait Modification | Week 1&2 | 8.0 degrees | Standard Deviation 7.1 |
| Immediate Intervention: Telerehabilitation | Real-world Performance of Gait Modification | Week 3&4 | 10.8 degrees | Standard Deviation 6.7 |
| Immediate Intervention: Telerehabilitation | Real-world Performance of Gait Modification | Week 5&6 | 12.0 degrees | Standard Deviation 6.6 |
| Immediate Intervention: Telerehabilitation | Real-world Performance of Gait Modification | Retention | 5.9 degrees | Standard Deviation 3.2 |
| Delayed Intervention: Telerehabilitation | Real-world Performance of Gait Modification | Retention | 9.73 degrees | Standard Deviation 4.5 |
| Delayed Intervention: Telerehabilitation | Real-world Performance of Gait Modification | Week 5&6 | 7.7 degrees | Standard Deviation 4.4 |
| Delayed Intervention: Telerehabilitation | Real-world Performance of Gait Modification | Week 1&2 | 5.3 degrees | Standard Deviation 3.9 |
| Delayed Intervention: Telerehabilitation | Real-world Performance of Gait Modification | Follow up | 10.9 degrees | Standard Deviation 4.6 |
| Delayed Intervention: Telerehabilitation | Real-world Performance of Gait Modification | Week 3&4 | 9.26 degrees | Standard Deviation 3.4 |
Satisfaction With the Treatment Program
Satisfaction with the gait modification program on a 7-point Likert scale where -3 = extremely unsatisfied and +3 = extremely satisfied. Scores of +2 or +3 will be considered satisfied and acceptable.
Time frame: Week 6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immediate Intervention: Telerehabilitation | Satisfaction With the Treatment Program | 2.5 score on a scale |
| Delayed Intervention: Telerehabilitation | Satisfaction With the Treatment Program | 2 score on a scale |
Knee Joint Moment Impulse
Impulse of the knee adduction and flexion moments.
Time frame: Baseline, Week 6
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Intervention: Telerehabilitation | Knee Joint Moment Impulse | KAM Impulse Baseline | 0.16 Nm/kg*s |
| Immediate Intervention: Telerehabilitation | Knee Joint Moment Impulse | KFM Impulse Baseline | 0.1 Nm/kg*s |
| Immediate Intervention: Telerehabilitation | Knee Joint Moment Impulse | KAM Impulse Week 6 | 0.15 Nm/kg*s |
| Immediate Intervention: Telerehabilitation | Knee Joint Moment Impulse | KFM Impulse Week 6 | 0.11 Nm/kg*s |
| Delayed Intervention: Telerehabilitation | Knee Joint Moment Impulse | KAM Impulse Week 6 | 0.17 Nm/kg*s |
| Delayed Intervention: Telerehabilitation | Knee Joint Moment Impulse | KAM Impulse Baseline | 0.18 Nm/kg*s |
| Delayed Intervention: Telerehabilitation | Knee Joint Moment Impulse | KFM Impulse Week 6 | 0.13 Nm/kg*s |
| Delayed Intervention: Telerehabilitation | Knee Joint Moment Impulse | KFM Impulse Baseline | 0.13 Nm/kg*s |
Knee Joint Moments
Peaks and impulse of the knee adduction moment and knee flexion moment measured via in-laboratory gait analysis (force platforms and marker-based motion capture) at baseline, and follow up.
Time frame: Baseline, Week 6
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Intervention: Telerehabilitation | Knee Joint Moments | Baseline KAM1 | 0.56 Nm/kg |
| Immediate Intervention: Telerehabilitation | Knee Joint Moments | Week 6 KAM1 | 0.49 Nm/kg |
| Immediate Intervention: Telerehabilitation | Knee Joint Moments | Baseline KAM2 | 0.30 Nm/kg |
| Immediate Intervention: Telerehabilitation | Knee Joint Moments | Week 6 KAM2 | 0.28 Nm/kg |
| Immediate Intervention: Telerehabilitation | Knee Joint Moments | Baseline KFM peak | 0.70 Nm/kg |
| Immediate Intervention: Telerehabilitation | Knee Joint Moments | Week 6 KFM peak | 0.72 Nm/kg |
| Delayed Intervention: Telerehabilitation | Knee Joint Moments | Baseline KFM peak | 0.66 Nm/kg |
| Delayed Intervention: Telerehabilitation | Knee Joint Moments | Baseline KAM1 | 0.50 Nm/kg |
| Delayed Intervention: Telerehabilitation | Knee Joint Moments | Week 6 KAM2 | 0.32 Nm/kg |
| Delayed Intervention: Telerehabilitation | Knee Joint Moments | Week 6 KAM1 | 0.45 Nm/kg |
| Delayed Intervention: Telerehabilitation | Knee Joint Moments | Week 6 KFM peak | 0.68 Nm/kg |
| Delayed Intervention: Telerehabilitation | Knee Joint Moments | Baseline KAM2 | 0.33 Nm/kg |
Knee-osteoarthritis Related Symptoms
Change in pain (9 items), stiffness (7 items), physical function (17 items), and quality of life (4 items) will be measured by the Knee Injury and Osteoarthritis Outcome Score at baseline, follow up and retention. Each item is rated on a 5 points Likert scale where 0 = No problems and 4 = Extreme Problems. Higher scores indicate better function. The scores are normalized to 0-100%.
Time frame: Baseline, Week 6
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Baseline Pain | 60.6 scores on a scale |
| Immediate Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Week 6 Pain | 65.0 scores on a scale |
| Immediate Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Baseline Stiffness | 55.0 scores on a scale |
| Immediate Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Week 6 Stiffness | 65.0 scores on a scale |
| Immediate Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Baseline Physical Function | 65.9 scores on a scale |
| Immediate Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Week 6 Physical Function | 74.3 scores on a scale |
| Immediate Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Baseline Quality of Life | 41.0 scores on a scale |
| Immediate Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Week 6 Quality of Life | 47.0 scores on a scale |
| Delayed Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Week 6 Quality of Life | 48.5 scores on a scale |
| Delayed Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Baseline Pain | 59.2 scores on a scale |
| Delayed Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Baseline Physical Function | 72.9 scores on a scale |
| Delayed Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Week 6 Pain | 61.9 scores on a scale |
| Delayed Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Baseline Quality of Life | 42.0 scores on a scale |
| Delayed Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Baseline Stiffness | 60.7 scores on a scale |
| Delayed Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Week 6 Physical Function | 77.6 scores on a scale |
| Delayed Intervention: Telerehabilitation | Knee-osteoarthritis Related Symptoms | Week 6 Stiffness | 61.4 scores on a scale |