Effects of Sensorimotor Insoles on Stability and Gait in Patients With Multiple Sclerosis. (NCT07735325) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Sensorimotor Insoles on Stability and Gait in Patients With Multiple Sclerosis.
Spain50 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing sensorimotor insoles for stability in people with multiple sclerosis — is improving balance and gait stability one of my most pressing concerns right now, and would my doctor think this kind of intervention makes sense for my current stage of MS?
2Since this trial is listed as 'active, not recruiting,' it's no longer enrolling new participants — are there similar studies or treatments involving sensorimotor insoles that I could still access or ask about?
3This study is Phase NA, meaning it's likely a device or rehabilitation study rather than a drug trial — what does my doctor know about the existing evidence for sensorimotor insoles in MS patients, and how strong is that evidence so far?
4The trial is focused on measuring stability as its primary outcome — given my personal history with falls or balance problems, does my doctor think a non-drug approach like specialized insoles could realistically complement my current MS treatment plan?
5If sensorimotor insoles show promise for stability in MS, is this something my doctor could already prescribe or refer me to through standard care, rather than waiting for trial results?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.