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

NCT07735325 | Active Not Recruiting

• 1 other identifier: INV2026-68
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Keywords

Sensorimotor insoles; multiple sclerosis; gait; stability

Outcome Measures

Primary Outcomes (1)

• Stability

  Berg Balance Scale

  6 months

Secondary Outcomes (4)

• Gait

  6 months

• Plantar cutaneous sensitivity

  6 months

• Ankle strength

  6 months

• Function and Quality of life

  6 months

Study Arms (2)

Intervention group: use of sensorimotor insoles

EXPERIMENTAL

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

Comtrol group

NO INTERVENTION

Interventions

Sensorimotor insoles DEVICE

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.

Intervention group: use of sensorimotor insoles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Universidad de Salamanca

Salamanca, Salamanca, 37001, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of physical therapy

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

ES (1)