search
Back to results

Gait Modification for Knee Osteoarthritis (SENSMOD)

Primary Purpose

Osteoarthritis, Knee

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Specific Modification Target
Self-directed Modification
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

Eligibility Criteria

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

Inclusion Criteria:

  • Be 50 years of age or greater
  • Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) 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
  • Are comfortable walking intermittently for 30 minutes
  • Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13)
  • Exhibit at least a 5% reduction in knee adduction moment impulse for 10 degrees of change to foot rotation measured during a 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 Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Specific Modification Target

Self-directed Modification

Arm Description

A 15 degree relative increase to foot progression angle

A self-directed increase to foot progression angle that is "as much as is comfortable".

Outcomes

Primary Outcome Measures

Change in baseline to week 7 foot rotation angle error during stance - in lab walking
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot (heel to toe) and the walking direction. Foot rotation will be measured via standard marker-based motion capture and sensor-based motion capture during baseline, follow up, and each practice session.
Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot and the walking direction. Foot rotation will be measured via sensor-based motion capture over each week of the intervention. Median and inter-quartile ranges will be taken as the primary summary statistic.

Secondary Outcome Measures

Change in baseline to week 7 knee joint moment impulse
Knee flexion and adduction moment impulses will be calculated. Participants will walk on an instrumented walkway (2 force platforms) while 14 high speed cameras track the trajectories of markers placed on boney landmarks. Moments will be calculated using an inverse dynamics approach.
Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)
Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis. The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.
Change in baseline to week 7 knee pain on a numerical rating scale
Knee pain rated on a 0 to 10 scale. 0 = "no pain at all" and 10 = "worst pain imaginable".
Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale
Difficulty will be rated on a 0 to 10 scale. 0 = "no difficulty at all" and 10 = "most difficulty imaginable".

Full Information

First Posted
February 3, 2020
Last Updated
October 15, 2020
Sponsor
University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT04323969
Brief Title
Gait Modification for Knee Osteoarthritis
Acronym
SENSMOD
Official Title
Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-related laboratory shutdown.
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

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
This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention. Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom sensorized shoe.
Detailed Description
Greater toe-in or toe-out angles during walking are potential biomechanical management strategies for medial compartment knee osteoarthritis (OA). Multi-week clinical trials demonstrate the biomechanical efficacy and potential clinical efficacy. However, walking biomechanics have only been assessed within laboratory environments and performance of the modifications during daily at-home walking is currently unknown. Furthermore, the modifications have largely been instructed using a specific target, requiring motor learning. No study has examined whether a self-directed strategy is feasible and will produce significant improvements in biomechanical and clinical outcomes. Moreover, objective real-world performance of these modifications is unknown and may explain the previous inconsistent clinical results. This study will address these gaps. The investigators hypothesize that real-world performance of the modifications will improve over the intervention and that both groups will exhibit improvements in biomechanical and clinical outcomes at follow up.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specific Modification Target
Arm Type
Experimental
Arm Description
A 15 degree relative increase to foot progression angle
Arm Title
Self-directed Modification
Arm Type
Experimental
Arm Description
A self-directed increase to foot progression angle that is "as much as is comfortable".
Intervention Type
Behavioral
Intervention Name(s)
Specific Modification Target
Intervention Description
Participants will be instructed to increase their baseline foot progression angle by 15 degrees. Visual feedback during practice will be delivered using a mirror and guideline (tape placed on mirror). Verbal feedback will be incorporated to encourage participants to perform the modified foot progression angle as accurately as possible.
Intervention Type
Behavioral
Intervention Name(s)
Self-directed Modification
Intervention Description
Participants will be instructed to modify their foot progression angle as much as is comfortable. A mirror will be used during practice for visual feedback, but no specific target or guide will be provided.
Primary Outcome Measure Information:
Title
Change in baseline to week 7 foot rotation angle error during stance - in lab walking
Description
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot (heel to toe) and the walking direction. Foot rotation will be measured via standard marker-based motion capture and sensor-based motion capture during baseline, follow up, and each practice session.
Time Frame
Baseline, Week 7
Title
Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions
Description
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot and the walking direction. Foot rotation will be measured via sensor-based motion capture over each week of the intervention. Median and inter-quartile ranges will be taken as the primary summary statistic.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7
Secondary Outcome Measure Information:
Title
Change in baseline to week 7 knee joint moment impulse
Description
Knee flexion and adduction moment impulses will be calculated. Participants will walk on an instrumented walkway (2 force platforms) while 14 high speed cameras track the trajectories of markers placed on boney landmarks. Moments will be calculated using an inverse dynamics approach.
Time Frame
Baseline, Week 7
Title
Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis. The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.
Time Frame
Baseline, Week 7
Title
Change in baseline to week 7 knee pain on a numerical rating scale
Description
Knee pain rated on a 0 to 10 scale. 0 = "no pain at all" and 10 = "worst pain imaginable".
Time Frame
Baseline, Week 7
Title
Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale
Description
Difficulty will be rated on a 0 to 10 scale. 0 = "no difficulty at all" and 10 = "most difficulty imaginable".
Time Frame
Week 1, 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be 50 years of age or greater Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) 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 Are comfortable walking intermittently for 30 minutes Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13) Exhibit at least a 5% reduction in knee adduction moment impulse for 10 degrees of change to foot rotation measured during a 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hunt, PT, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motion Analysis and Biofeedback Laboratory
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gait Modification for Knee Osteoarthritis

We'll reach out to this number within 24 hrs