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Telerehabilitation Gait Modification (TELEMOD)

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Foot rotation modification
Waiting Period - Delayed Group
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Gait Modification, Wearable Sensors, Real-world Monitoring, Telerehabilitation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Motion Analysis and Biofeedback LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate Intervention: Telerehabilitation

Delayed Intervention: Telerehabilitation

Arm Description

Immediate entry into the gait modification intervention delivered using teleconferencing methods

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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".
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.

Full Information

First Posted
December 15, 2020
Last Updated
May 16, 2022
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04683913
Brief Title
Telerehabilitation Gait Modification
Acronym
TELEMOD
Official Title
Foot Progression Angle Modification: an Exploratory Six-week Telerehabilitation Intervention in People With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Gait Modification, Wearable Sensors, Real-world Monitoring, Telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm delayed control design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention: Telerehabilitation
Arm Type
Experimental
Arm Description
Immediate entry into the gait modification intervention delivered using teleconferencing methods
Arm Title
Delayed Intervention: Telerehabilitation
Arm Type
Experimental
Arm Description
Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods
Intervention Type
Behavioral
Intervention Name(s)
Foot rotation modification
Other Intervention Name(s)
gait modification
Intervention Description
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
Other
Intervention Name(s)
Waiting Period - Delayed Group
Other Intervention Name(s)
control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lab-measured performance of gait modification
Description
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.
Time Frame
Baseline, Week 6, Week 10
Title
Real-world performance of gait modification
Description
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.
Time Frame
Baseline, Week 6, Week 10
Title
Intervention adherence
Description
Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total).
Time Frame
Week 6
Title
Compliance with gait modification
Description
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.
Time Frame
Week 1, Week 6, Week 10
Title
Difficulty in performing the modification
Description
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.
Time Frame
Week 1, Week 6, Week 10
Title
Satisfaction with the treatment program
Description
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.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Knee-osteoarthritis related symptoms
Description
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".
Time Frame
Baseline, Week 6, Week 10
Title
Knee joint moments
Description
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.
Time Frame
Baseline, Week 6, Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Krowchuk, BSc
Phone
6048227948
Email
natasha.krowchuk@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Hunt, PT, PhD
Phone
6048274721
Email
michael.hunt@ubc.ca
Facility Information:
Facility Name
Motion Analysis and Biofeedback Laboratory
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Krowchuk, BSc
Phone
6048227948
Email
natasha.krowchuk@ubc.ca
First Name & Middle Initial & Last Name & Degree
Michael A Hunt, PT, PhD
Phone
6048274721
Email
michael.hunt@ubc.ca
First Name & Middle Initial & Last Name & Degree
Jesse Charlton, MSc
First Name & Middle Initial & Last Name & Degree
Natasha Krowchuk, BSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Telerehabilitation Gait Modification

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