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COMPLETED
NCT06598696

Biomechanical and Clinical Evaluation of a Gait Modifying Device for Treating Knee Pain

Sponsor: Scientific Motion Technologies, Inc.

View on ClinicalTrials.gov

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

DEVICE

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.