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Biomechanical and Clinical Evaluation of a Gait Modifying Device for Treating Knee Pain
Sponsor: Scientific Motion Technologies, Inc.
Summary
The goal of this clinical trial is to determine if gait-modification therapy via custom shoe intervention can reduce knee pain and improve gait parameters in individuals experiencing chronic (\>6 month) knee pain. The main questions it aims to answer are: * Do patient-reported outcomes related to knee pain improve with the use of gait-modifying shoes? * Do gait-modifying shoes change gait parameters (speed, step length, single limb support, and symmetry)? Participants will: * Attend an initial assessment and treatment visit lasting less than 2 hours. * Wear gait-modifying shoes daily for 12 weeks, gradually increasing the duration of wear as prescribed. * Record the daily time worn and pain levels on a provided chart. * Attend three follow-up visits, each lasting less than 1 hour, for treatment adjustments and data collection.
Key Details
Gender
All
Age Range
40 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2025-01-03
Completion Date
2025-10-08
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
Gait-Modifying Shoe Intervention
The intervention involves the use of specially designed shoes intended to modify the wearer's gait. These shoes feature specific design elements aimed at reducing knee pain and improving overall gait mechanics and spatiotemporal parameters. The shoes will be modified using a one piece attachment altered systematically on a measured XYR control panel based on individual patient presentation upon assessment to optimize gait mechanics and minimize pain with ambulation. Participants will be instructed to wear the shoes for increasing periods each day over the 12-week period. Knee pain will be assessed using validated questionnaires, and gait parameters will be measured using motion capture technology at each follow-up visit.