Gait Modification for Knee Osteoarthritis (SENSMOD)

University of British Columbia

Status: Terminated

Conditions: Osteoarthritis, Knee

Treatments: Behavioral: Self-directed Modification; Behavioral: Specific Modification Target

Study type: Interventional

Funder types: Other

Identifiers

NCT04323969

H19-02621

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 2 patient groups

Specific Modification Target

Experimental group

Description:

A 15 degree relative increase to foot progression angle

Treatment:

Behavioral: Specific Modification Target

Self-directed Modification

Experimental group

Description:

A self-directed increase to foot progression angle that is "as much as is comfortable".

Treatment:

Behavioral: Self-directed Modification