Gait Modification Treatment for Knee Osteoarthritis

NCT ID: NCT02019108

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-10-31

Brief Summary

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Progressive walking program with toe-out gait modification

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Progressive walking program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Melbourne

OTHER

Sponsor Role: collaborator

Arthritis Research Centre of Canada

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Michael Hunt

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A Hunt, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

Motion Analysis and Biofeedback Laboratory, The University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

References

Hunt MA, Charlton JM, Krowchuk NM, Tse CTF, Hatfield GL. Clinical and biomechanical changes following a 4-month toe-out gait modification program for people with medial knee osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2018 Jul;26(7):903-911. doi: 10.1016/j.joca.2018.04.010. Epub 2018 Apr 27.

Reference Type: DERIVED

PMID: 29709498 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOG-13-024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H13-02688

Identifier Type: -

Identifier Source: org_study_id