Gait Modification Treatment for Knee Osteoarthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of British Columbia
Sponsor:
Collaborators:
University of Melbourne
Arthritis Research Centre of Canada
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02019108
First received: December 5, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

Knee osteoarthritis (OA) is a costly health condition affecting more than 10% of Canadian adults. Excessive and unbalanced loads passing through the knee joint have been implicated in the progression of OA. Typical conservative treatment of OA has focused on increasing daily activity, without consideration for the underlying joint loading. This study aims to compare a 4-month walking program that aims to increase the angle of the foot (toe-out angle) during walking - a measure shown to reduce joint loading and OA disease progression - while increasing walking time/distance, with a standard walking program that aims to increase walking time/distance. It is predicted that the walking program focusing on increasing toe-out will provide greater reductions in self-reported knee pain and a greater reduction in unfavorable knee joint loading.


Condition Intervention
Knee Osteoarthritis
Other: Progressive walking program with toe-out gait modification
Other: Progressive walking program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Toe-out Gait Modification on Clinical and Biomechanical Measures in People With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in Pain [ Time Frame: Weeks 0, 17, 21 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Self-reported physical function [ Time Frame: Weeks 0, 17, 21 ] [ Designated as safety issue: No ]
    The physical function subscale (17 questions) of the WOMAC will be used.

  • Change in Objective physical function [ Time Frame: Weeks 0, 17, 21 ] [ Designated as safety issue: No ]
    The time required to ascend and descend a flight of 10 stairs will be used as an objective measure of physical function.


Estimated Enrollment: 80
Study Start Date: May 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 50 years and older
  • radiographically confirmed medial compartment tibia-femoral knee osteoarthritis
  • available for weekly training sessions in the Vancouver British Columbia Canada region
  • able to safely perform treadmill walking under therapist supervision

Exclusion Criteria:

  • articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
  • inflammatory arthritic condition
  • history of knee replacement or arthroscopic knee surgery
  • recent use of corticosteroids (oral or via injection)
  • inability to ambulate without a gait aid
  • non-English speaking
  • planning to commence a new treatment approach within the next 4 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019108

Contacts
Contact: Christopher K Cochrane, BSc 604-822-7948 chris.cochrane@ubc.ca
Contact: Michael A Hunt, PT, PhD 604-827-4721 michael.hunt@ubc.ca

Locations
Canada, British Columbia
Motion Analysis and Biofeedback Laboratory, The University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Contact: Christopher K Cochrane, BSc    604-822-7948    chris.cochrane@ubc.ca   
Principal Investigator: Michael A Hunt, PT, PhD         
Sub-Investigator: David R Wilson, DPhil, BEng         
Sub-Investigator: Charles Goldsmith, PhD         
Sub-Investigator: Marcus Pandy, PhD         
Sponsors and Collaborators
University of British Columbia
University of Melbourne
Arthritis Research Centre of Canada
Investigators
Principal Investigator: Michael A Hunt, PT, PhD The University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02019108     History of Changes
Other Study ID Numbers: H13-02688, SOG-13-024
Study First Received: December 5, 2013
Last Updated: May 8, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
osteoarthritis
knee
walking
toeout
gait modification

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014