Clinical trial NCT02019108: Gait Modification Treatment for Knee Osteoarthritis
Official title: Effects of Toe-out Gait Modification on Clinical and Biomechanical Measures in People With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis
knee
walking
toeout
gait modification
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Melbourne
name: Arthritis Research Centre of Canada
First posted: 2013-12-24
Enrollment: 79
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale
timeFrame: Weeks 0, 17, 21
measure: Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.
timeFrame: Weeks 0, 17, 21
measure: Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment
timeFrame: Weeks 0, 17, 21
measure: Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment
timeFrame: Weeks 0, 17, 21
measure: Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse
timeFrame: Weeks 0, 17, 21
measure: Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA)
timeFrame: Weeks 0, 17, 21
Secondary outcomes:
measure: Change From Baseline to Week 17 and From Baseline to Week 21 in Self-reported Physical Function as Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale.
timeFrame: Weeks 0, 17, 21
measure: Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb.
timeFrame: Weeks 0, 17, 21
measure: Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment
timeFrame: Weeks 0, 17, 21
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Motion Analysis and Biofeedback Laboratory, The University of British Columbia
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Michael A Hunt, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.