Effects of Sensorimotor Insoles on Stability and Gait in Patients With Multiple Sclerosis.

This study is a single-blind, randomized controlled clinical trial designed to evaluate the long-term physiological and functional effects of sensorimotor insoles (SMIs) in individuals diagnosed with Multiple Sclerosis (MS). Intervention Protocol and Device Customization Participants allocated to the experimental group receive custom-fabricated SMIs (Anatomy Line model, Springer Aktiv GmbH, Berlin, Germany). Digital foot models are generated using a mobile application (Foot Scan 3D) coupled with a specialized phone mirror device to capture three-dimensional foot morphology for custom orthosis manufacturing. To ensure patient safety, promote acclimatization, and minimize potential adverse events, a structured 1-month adaptation protocol is implemented: Adaptation Phase (Month 1): Participants wear the SMIs starting at 1 hour per day, increasing wear time by 1 hour every 3 days. SMI usage is initially restricted to indoor activities before expanding to outdoor use. Maintenance Phase (Months 2-7): Following adaptation, participants wear the custom SMIs continuously during all daily activities within their habitual footwear. The control group receives no study-specific insole intervention. To control for confounding rehabilitation effects, participants in both the experimental and control groups maintain their conventional, ongoing physical therapy regimens throughout the 7-month study period. Evaluator Blinding and Site Logistics All outcome assessments take place at baseline and immediately following the 7-month intervention period at the facilities of the Asociación Vallisoletana de Esclerosis Múltiple. To maintain single-blind integrity, outcome evaluations are conducted by assessors who are fully masked to participant group assignment. Participant recruitment, randomization, and intervention monitoring are handled by independent research team members who do not perform outcome testing.