Custom insoles may steady the steps of MS patients — a trial puts them to the test
NCT ID NCT07735325
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests whether custom-designed sensorimotor insoles, worn daily for six months, can improve balance and walking in people with multiple sclerosis. Fifty adults with MS (mild to moderate disability) will be randomly assigned to receive the insoles or continue their usual care. Researchers will measure changes in stability, gait, foot sensation, ankle strength, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- custom sensorimotor insoles (Anatomy Line SMIs) worn daily for at least 5 hours over 6 months
- What this could lead to
- If effective, these insoles could offer a simple, non-drug way to improve balance and walking for people with multiple sclerosis.
- What could go wrong
- This is a small, early-stage trial with only 50 participants. The insoles may not provide meaningful benefits over standard care, and results may not apply to all MS types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Universidad de Salamanca
Salamanca, Salamanca, 37001, Spain
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Other studies related to the condition(s) this trial covers.
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