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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Sensorimotor insoles

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Salamanca
    • Salamanca, Salamanca, Spain, 37001
      • Universidad de Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Medical diagnosis of multiple sclerosis (MS), including relapsing-remitting, primary progressive, or secondary progressive subtypes.
• Age > 18 years.
• Expanded Disability Status Scale (EDSS) score between 2.0 and 6.0 (ranging from minimal disability to requiring a cane to walk).
• Signed written informed consent.

Exclusion Criteria:

• Cognitive impairment.
• Visual or vestibular disorders that could impair stability.
• Changes in disease-specific medication within the 2 months prior to study baseline.
• MS relapse within the 2 months prior to study baseline (for relapsing-remitting MS cases).
• Lower-limb capsuloligamentous injury within the 2 months prior to study baseline (such as ankle or knee sprains) that could affect stability or gait pattern.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group: use of 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.	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.
No Intervention: Comtrol group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability	Berg Balance Scale	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait	Gait Assessment and Intervention Tool	6 months
Plantar cutaneous sensitivity	Pressure treshold	6 months
Ankle strength	Manual dynamometry	6 months
Function and Quality of life	Functional Assessment of Multiple Sclerosis	6 months

Collaborators and Investigators

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 23, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: gait; multiple sclerosis; stability; Sensorimotor insoles
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: INV2026-68

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No