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

NCT07735325 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Sensorimotor insoles

Daily use of sensorimotor insoles for at least 5 hours per day over a 6-month period. The insoles will be worn during activities of daily living or sports activities and are custom-designed for each participant. At the beginning of the study, an adaptation period will be implemented during which insole wear time is progressively increased.

Sponsors & Collaborators

  • University of Salamanca

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735325 on ClinicalTrials.gov