Gait Modification for Knee Osteoarthritis (SENSMOD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04323969|
Recruitment Status : Terminated (COVID-related laboratory shutdown.)
First Posted : March 27, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Behavioral: Specific Modification Target Behavioral: Self-directed Modification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis|
|Actual Study Start Date :||February 20, 2020|
|Actual Primary Completion Date :||March 12, 2020|
|Actual Study Completion Date :||March 12, 2020|
Experimental: Specific Modification Target
A 15 degree relative increase to foot progression angle
Behavioral: Specific Modification Target
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.
Experimental: Self-directed Modification
A self-directed increase to foot progression angle that is "as much as is comfortable".
Behavioral: Self-directed Modification
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.
- Change in baseline to week 7 foot rotation angle error during stance - in lab walking [ Time Frame: Baseline, Week 7 ]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 [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7 ]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.
- Change in baseline to week 7 knee joint moment impulse [ Time Frame: Baseline, Week 7 ]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) [ Time Frame: Baseline, Week 7 ]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 [ Time Frame: Baseline, Week 7 ]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 [ Time Frame: Week 1, 7 ]Difficulty will be rated on a 0 to 10 scale. 0 = "no difficulty at all" and 10 = "most difficulty imaginable".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323969
|Canada, British Columbia|
|Motion Analysis and Biofeedback Laboratory|
|Vancouver, British Columbia, Canada, V6T 1Z3|
|Principal Investigator:||Michael Hunt, PT, PhD||University of British Columbia|