Gait Modification for Knee Osteoarthritis

Not Applicable

Terminated

Interventions: Behavioral: Self-directed Modification
Behavioral: Specific Modification Target

Brief Summary: This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention. Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom sensorized shoe.

Detailed Description: Greater toe-in or toe-out angles during walking are potential biomechanical management strategies for medial compartment knee osteoarthritis (OA). Multi-week clinical trials demonstrate the biomechanical efficacy and potential clinical efficacy. However, walking biomechanics have only been assessed within laboratory environments and performance of the modifications during daily at-home walking is currently unknown. Furthermore, the modifications have largely been instructed using a specific target, requiring motor learning. No study has examined whether a self-directed strategy is feasible and will produce significant improvements in biomechanical and clinical outcomes. Moreover, objective real-world performance of these modifications is unknown and may explain the previous inconsistent clinical results. This study will address these gaps. The investigators hypothesize that real-world performance of the modifications will improve over the intervention and that both groups will exhibit improvements in biomechanical and clinical outcomes at follow up.

Recruitment & Eligibility

Inclusion Criteria

Be 50 years of age or greater
Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) grading scale) predominantly in the medial compartment,
Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = "no pain" and 10 = "worst pain imaginable") during most days of the previous month
Are comfortable walking intermittently for 30 minutes
Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13)
Exhibit at least a 5% reduction in knee adduction moment impulse for 10 degrees of change to foot rotation measured during a screening appointment.

Exclusion Criteria

Any knee surgery or intraarticular injections within the past 6 months
A history of joint replacement surgery or high tibial osteotomy
Current or recent (within 6 weeks) corticosteroid injections
Use of a gait aid
Currently on a wait list for joint replacement surgery or high tibial osteotomy
Any inflammatory arthritic condition
Any other conditions that may affect normal gait or participation in an aerobic exercise program
Cannot attend all required appointments.

Arm && Interventions

Group	Intervention	Description
Self-directed Modification	Self-directed Modification	A self-directed increase to foot progression angle that is "as much as is comfortable".
Specific Modification Target	Specific Modification Target	A 15 degree relative increase to foot progression angle

Primary Outcome Measures

Name	Time	Method
Change in baseline to week 7 foot rotation angle error during stance - in lab walking	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)	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	Baseline, Week 7	Knee pain rated on a 0 to 10 scale. 0 = "no pain at all" and 10 = "worst pain imaginable".
Change in baseline to week 7 knee joint moment impulse	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 week 1 to week 7 difficulty performing the modification on a numerical rating scale	Week 1, 7	Difficulty will be rated on a 0 to 10 scale. 0 = "no difficulty at all" and 10 = "most difficulty imaginable".

Locations (1): Motion Analysis and Biofeedback Laboratory
🇨🇦
Vancouver, British Columbia, Canada