Effects of wearing textured versus smooth shoe insoles for 12 weeks on gait, foot sensation and patient-reported outcomes, in people with multiple sclerosis: a randomised controlled trial

Abstract Background: Innovative shoe insoles, designed to enhance sensory information on the plantar surface of feet, could help improve walking in people with Multiple Sclerosis. Objective: To compare effects wearing textured versus smooth measures gait, foot sensation and patient-reported outcomes, Methods: A prospective, randomised controlled trial was conducted concealed allocation, assessor blinding intention-to-treat analysis. Thirty ambulant men women multiple sclerosis (MS) (Disease Steps rating 1–4) were randomly allocated wear or insoles for 12 weeks. Self-reported insole falls diaries completed over intervention period. Laboratory assessments spatiotemporal gait patterns, proprioception, performed at Weeks 0 (Baseline 1), 4 2) 16 (Post-Intervention). The primary outcome size mediolateral base support (stride/step width) when even uneven surfaces. Independent t -tests change from baseline (average measures) post-intervention. Results: There no differences stride width between groups, surfaces ( P ≥ 0.20) between-group any secondary outcomes including (all values > 0.23), function 0.08) 0.23). Conclusions: In our small trial, prolonged did not appear alter MS who have limited loss. Further investigation is needed explore optimal design. Clinical Trial Registration: Australian New Zealand Trials Registry (ACTRN12615000421538).