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

Overview

This single-blind, randomized controlled clinical trial aims to evaluate the long-term effects of using sensorimotor insoles (SMIs) on stability and gait capacity in individuals diagnosed with multiple sclerosis (MS). Secondary objectives include assessing the impact of SMIs on plantar cutaneous sensitivity, ankle muscle strength, quality of life, and overall functional status in this patient population.The study sample comprises 50 adult participants diagnosed with MS (including relapsing-remitting, primary progressive, and secondary progressive subtypes) with Expanded Disability Status Scale (EDSS) scores ranging from 2.0 to 6.0. Participants will be randomly allocated into an experimental group ($n = 25$) and a control group ($n = 25$). The experimental group will receive custom "Anatomy Line" SMIs (Springer Aktiv GmbH), fabricated using 3D digital foot models generated via the Foot Scan 3D mobile application. The intervention spans seven months, beginning with a one-month progressive adaptation period before transitioning to daily, full-day use within habitual footwear. The control group will receive no study-specific intervention, and participants in both groups will maintain their conventional physical therapy regimens throughout the study.All outcome measures will be evaluated at baseline and immediately following the 7-month intervention period by research team members who are blinded to group allocation. Primary outcomes include stability, evaluated using the Berg Balance Scale (BBS), and gait capacity, assessed via the Gait Assessment and Intervention Tool (GAIT). Secondary outcomes include plantar cutaneous sensitivity evaluated at three plantar sites using Semmes-Weinstein monofilaments, ankle muscle strength measured across four movement planes using an Activforce 2 digital handheld dynamometer, and health-related quality of life and functional status assessed through the 52-item Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.

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.