Telerehabilitation Gait Modification

Osteoarthritis, Knee Clinical Trial

— TELEMOD  

Official title:

Foot Progression Angle Modification: an Exploratory Six-week Telerehabilitation Intervention in People With Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04683913
• Other study ID #: H20-03086
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 2022

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: Natasha Krowchuk, BSc
• Phone: 6048227948
• Email: natasha.krowchuk[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• 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".

Other:
• 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.

Locations

Country	Name	City	State
Canada	Motion Analysis and Biofeedback Laboratory	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lab-measured performance of gait modification	Change in foot rotation angle between baseline and both week 6 (follow-up) and week 10 (retention) 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, Week 10
Primary	Real-world performance of gait modification	Change in 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 6, Week 10
Primary	Intervention adherence	Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total).	Week 6
Primary	Compliance with gait modification	Change in compliance will be estimated by self-reported confidence in performing the gait modification (where 0 = "no confidence" and 10 = "complete confidence") and will be assessed on a weekly basis within the diary. Acceptable confidence ratings by week 6 are greater than or equal to 7/10. Change will be compared from week 1 to week 6 and week 10.	Week 1, Week 6, Week 10
Primary	Difficulty in performing the modification	Change in difficulty of performing the modification from week 1 to week 6 and week 10. 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 1, Week 6, Week 10
Primary	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.	Baseline, Week 6
Secondary	Knee-osteoarthritis related symptoms	Change in pain, stiffness, physical function, and quality of life will be measured by the Knee Injury and Osteoarthritis Outcome Score at baseline, follow up and retention. Each question is rated on a 5 points Likert scale where 0 = "never" and 4 = "always".	Baseline, Week 6, Week 10
Secondary	Knee joint moments	Change in 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, follow up and retention.	Baseline, Week 6, Week 10