The Impact of a Sensor Based Platform on the Outcome of Medial Off-Loader Bracing in Individuals With Knee Osteoarthritis: A Pilot Randomized Clinical Trial

Objective Determine the effectiveness of a medial off-loader brace with sensor monitoring capabilities and associated phone application in improving outcomes for individuals with knee osteoarthritis (OA). Methods Randomized clinical trial of participants with knee OA, aged 40-75 with two groups: 1) brace-only 2) brace+sensor (sensor providing walking time, knee range of motion and 7-day activity streak). Both groups received a prefabricated custom-fitted medial off-loader brace and 12-week self-guided exercise therapy program. Baseline and post-intervention assessments included subjective and objective outcomes. Results 60 participants were recruited (n = 30/group). The brace+sensor group demonstrated higher study retention(88.89%) compared to the brace-only group(73.33%). Significant improvement in KOOS knee pain and other KOOS sub-scores compared to baseline was observed for both groups. However, only the brace+sensor group improved beyond the established minimal clinically important difference for KOOS pain(11.31+/-13.87). KOOS ADL was also significantly improved in the brace+sensor group compared to brace only group(p = 0.049). Both treatment groups had significant improvement in functional outcomes(10 m walk, 5x sit-to-stand, p < 0.05). Only the brace+sensor group had significant improvements in the 6-minute walk test(p = 0.02) and reduction in participant weight(p = 0.01) at 12 weeks. Conclusion Incorporating wearable technology in standard bracing for individuals with knee OA has potential in improving clinical outcomes.