Telerehabilitation Gait Modification

NCT ID: NCT04683913

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-05-20

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate Intervention: Telerehabilitation

Immediate entry into the gait modification intervention delivered using teleconferencing methods

Group Type: EXPERIMENTAL

Foot rotation modification

Intervention Type: BEHAVIORAL

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

Group Type: EXPERIMENTAL

Foot rotation modification

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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.

Interventions

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".

Intervention Type: BEHAVIORAL

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 Type: OTHER

Other Intervention Names

gait modification; control

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Michael Hunt

Professor, Assoc Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Motion Analysis and Biofeedback Laboratory

Vancouver, British Columbia, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H20-03086

Identifier Type: -

Identifier Source: org_study_id