Effects of orthopedic insoles on postural balance in patients with chronic stroke: A randomized crossover study

Background: Orthopedic insoles (OIs) with medial arch support and heel cushion are widely used to manage lower extremity injuries, but their effects on postural balance in patients with chronic stroke have not been adequately explored. Methods: Design: Double-blinded, sham-controlled, randomized crossover trial. Participants: A total of 32 ambulatory patients (20 men and 12 women, aged between 30 and 76 years) with more than 6 months since stroke onset. Interventions: All participants received one assessment session wearing OIs and one session wearing sham insole (SI) in a random order with a 1-day interval. Outcomes: Our primary outcome was the Berg Balance Scale score. Secondary outcomes included the Functional Reach Test, Timed Up and Go test, and computerized posturography. All were performed in both sessions. Subgroup analyses regarding demographic and functional variables were conducted to identify potential responders. Results: Significant between-insole differences favoring OIs were seen in all clinical tests (P < 0.05), but were seen only in the static medial-lateral sway in computerized posturography assessment (P = 0.04). An approximate 2-point difference in the BBS score favoring OIs was observed in all subgroups, not reaching the minimal clinically important difference. Conclusion: The use of OIs generated small but significant positive effects on improving postural balance among patients with chronic stroke. Additional biomechanical and clinical studies are required to evaluate their potential for routine clinical use. Trial registration: NCT03194282