Clinical trial NCT04683913: Telerehabilitation Gait Modification
Official title: Foot Progression Angle Modification: an Exploratory Six-week Telerehabilitation Intervention in People With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Gait Modification
Wearable Sensors
Real-world Monitoring
Telerehabilitation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm delayed control design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lab-measured Performance of Gait Modification
timeFrame: Baseline, Week 6
measure: Real-world Performance of Gait Modification
timeFrame: Baseline, Week 1&2, Week 3&4, Week 5&6, Follow up (Week 6/12), Retention (Week 10/16)
measure: Intervention Adherence
timeFrame: Week 6
measure: Compliance With Gait Modification
timeFrame: Week 6
measure: Difficulty in Performing the Modification
timeFrame: Week 6
measure: Satisfaction With the Treatment Program
timeFrame: Week 6
Secondary outcomes:
measure: Knee-osteoarthritis Related Symptoms
timeFrame: Baseline, Week 6
measure: Knee Joint Moments
timeFrame: Baseline, Week 6
measure: Knee Joint Moment Impulse
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Motion Analysis and Biofeedback Laboratory
state: British Columbia
Study officials:
References: