Gait Modification Treatment for Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT02019108|
Recruitment Status : Recruiting
First Posted : December 24, 2013
Last Update Posted : October 4, 2017
|Condition or disease||Intervention/treatment|
|Knee Osteoarthritis||Other: Progressive walking program with toe-out gait modification Other: Progressive walking program|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Toe-out Gait Modification on Clinical and Biomechanical Measures in People With Knee Osteoarthritis|
|Actual Study Start Date :||May 2014|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||October 2017|
Experimental: Gait Modification Group
Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait, with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well.
Other: Progressive walking program with toe-out gait modification
Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group.
Active Comparator: Walking Only Group
Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well.
Other: Progressive walking program
At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity.
- Change in Pain [ Time Frame: Weeks 0, 17, 21 ]Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = maximum pain). Lower-limb impairments will also be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies.
- Change in Knee joint loading [ Time Frame: Weeks 0, 17, 21 ]Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed, and the peak knee adduction moment (an indicator of knee joint load) from these 5 trials will be calculated and averaged. Joint contact forces will be calculated using a validated musculoskeletal model that integrates motion and muscle activation data developed by a study collaborator at Melbourne University.
- Change in Self-reported physical function [ Time Frame: Weeks 0, 17, 21 ]The physical function subscale (17 questions) of the WOMAC will be used.
- Change in Objective physical function [ Time Frame: Weeks 0, 17, 21 ]The time required to ascend and descend a flight of 10 stairs will be used as an objective measure of physical function.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019108
|Contact: Natasha M Krowchuk, BScfirstname.lastname@example.org|
|Contact: Michael A Hunt, PT, PhDemail@example.com|
|Canada, British Columbia|
|Motion Analysis and Biofeedback Laboratory, The University of British Columbia||Recruiting|
|Vancouver, British Columbia, Canada, V6T 1Z3|
|Contact: Natasha M Krowchuk, BSc 604-822-7948 firstname.lastname@example.org|
|Principal Investigator: Michael A Hunt, PT, PhD|
|Sub-Investigator: David R Wilson, DPhil, BEng|
|Sub-Investigator: Charles Goldsmith, PhD|
|Sub-Investigator: Marcus Pandy, PhD|
|Principal Investigator:||Michael A Hunt, PT, PhD||The University of British Columbia|