Telerehabilitation Gait Modification

NCT04683913 | Completed Results

• 1 other identifier: H20-03086
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Gait Modification; Wearable Sensors; Real-world Monitoring; Telerehabilitation

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline, Week 6

• 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.

  Baseline, Week 1&2, Week 3&4, Week 5&6, Follow up (Week 6/12), Retention (Week 10/16)

• Intervention Adherence

  Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total).

  Week 6

• 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.

  Week 6

• 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.

  Week 6

• 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.

  Week 6

Secondary Outcomes (3)

• Knee-osteoarthritis Related Symptoms

  Baseline, Week 6

• Knee Joint Moments

  Baseline, Week 6

• Knee Joint Moment Impulse

  Baseline, Week 6

Study Arms (2)

Immediate Intervention: Telerehabilitation

EXPERIMENTAL

Immediate entry into the gait modification intervention delivered using teleconferencing methods

Behavioral: Foot rotation modification

Delayed Intervention: Telerehabilitation

EXPERIMENTAL

Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods

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

Interventions

Foot rotation modification 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".

Also known as: gait modification

Delayed Intervention: Telerehabilitation; Immediate Intervention: Telerehabilitation

Waiting Period - Delayed Group 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.

Also known as: control

Delayed Intervention: Telerehabilitation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Motion Analysis and Biofeedback Laboratory

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Michael Hunt
• Organization: University of British Columbia

michael.hunt@ubc.ca

604-827-4721

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Assoc Dean

Model Details: Two-arm delayed control design

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 24, 2020
• Study Start: January 1, 2021
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: December 4, 2024
• Results First Posted: December 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)