Clinical trial NCT04323969: Gait Modification for Knee Osteoarthritis
Official title: Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Gait Modification
Wearable Sensors
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in baseline to week 7 foot rotation angle error during stance - in lab walking
timeFrame: Baseline, Week 7
measure: Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7
Secondary outcomes:
measure: Change in baseline to week 7 knee joint moment impulse
timeFrame: Baseline, Week 7
measure: Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, Week 7
measure: Change in baseline to week 7 knee pain on a numerical rating scale
timeFrame: Baseline, Week 7
measure: Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale
timeFrame: Week 1, 7
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Motion Analysis and Biofeedback Laboratory
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Michael Hunt, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: