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Smart insoles could revolutionize MS monitoring at home

NCT ID NCT05781113

Knowledge-focused Sponsor: Celestra Health Systems Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a smart insole and phone app that track walking patterns in people with multiple sclerosis (MS). The goal is to see if this wearable device can reliably detect changes in a person's condition during daily life. 90 adults with MS will use the device at home for 6 months while researchers measure how well they stick with the routine and whether doctors find the data useful.

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.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of 90 PwMS equally spread across 3 sites / geographies, with approximately 10% of patients in the EDSS 0 to 2.5 range, 45% of patients in EDSS range 3-4.5 and 45% of patients in EDSS range 5 to 6.5 (some patients within this latter group will use walking supports in the form of AFOs, electronic foot braces, etc.).

Ages

18 to 60 years

Sex

Anyone

Show 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: * Participants must have a diagnosis of Multiple Sclerosis (MS) based on the McDonald criteria, within an age range of 18 to 60. * The participant must have an Extended Disability Status Scale (EDSS) score at screening less than or equal to 6.5, inclusive. * The participant cohort will include at least 3 participants at each site exhibiting one of the following gait phenotypes: ataxic, hemiplegic and spastic. (Some participants may exhibit more than one phenotype). * The participant cohort will include at least 3 participants at each site with a progressive form of MS. Exclusion Criteria: * Participants that are currently suffering from a musculoskeletal injury (e.g., sprain, fracture, strain, etc.) that limits their ability to use their full range of motion of any joint at the time of recruitment. * Inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • The Ottawa Hospital

    Ottawa, Ontario, K1H8L6, Canada

  • The Royal London Hospital

    London, E1 IFR, United Kingdom

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