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 to 75 with two groups: (1) brace-only (2) brace plus 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 plus 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 plus 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 plus 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 plus 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.

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