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: The aim of the study is to 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.

Methods: This is a randomized clinical trial of participants with knee osteoarthritis, aged 40-75 with two groups: 1) brace-only and 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-wk self-guided exercise therapy program. Baseline and postintervention assessments included subjective and objective outcomes.

Results: Sixty participants were recruited ( n = 30/group). The brace+sensor group demonstrated higher study retention (88.89%) compared with the brace-only group (73.33%). Significant improvement in Knee Injury and Osteoarthritis Outcome Survey knee pain and other Knee Injury and Osteoarthritis Outcome Survey subscores compared with baseline was observed for both groups. However, only the brace+sensor group improved beyond the established minimal clinically important difference for Knee Injury and Osteoarthritis Outcome Survey pain (11.31 ± 13.87). Knee Injury and Osteoarthritis Outcome Survey activities of daily living was also significantly improved in the brace+sensor group compared with brace-only group ( P = 0.049). Both treatment groups had significant improvement in functional outcomes (10-m walk, 5× sit-to-stand, P < 0.05). Only the brace+sensor group had significant improvements in the 6-min walk test ( P = 0.02) and reduction in participant weight ( P = 0.01) at 12 wks.

Conclusions: Incorporating wearable technology in standard bracing for individuals with knee osteoarthritis has potential in improving clinical outcomes.