Telerehabilitation Gait Modification

Not Applicable

Completed

Conditions: Osteoarthritis, Knee

Interventions: Behavioral: Foot rotation modification
Other: Waiting Period - Delayed Group

Registration Number: NCT04683913

Lead Sponsor: University of British Columbia

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Intervention: Telerehabilitation	Foot rotation modification	Immediate entry into the gait modification intervention delivered using teleconferencing methods
Delayed Intervention: Telerehabilitation	Foot rotation modification	Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods
Delayed Intervention: Telerehabilitation	Waiting Period - Delayed Group	Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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%.
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.