NCT05781113Active, not recruiting
A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Condition
A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Disease Condition Through Home Monitoring of MS Patients
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
To measure the effectiveness of a Remote Patient Monitoring solution based on the use of a smart insole wearable device (and associated smart phone app), for monitoring MS patients' condition on a day-to-day basis. The main focus is the objective measurement of gait, given that 75% of people with MS display clinically significant gait impairments. Initial gait lab "gold standard" data indicate that the Artificial Intelligence (AI)-based digital biomarker will prove to be highly effective at detecting changes in the MS patient's condition.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 27 Jan 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Celestra Health Systems
- Diseases
- Multiple sclerosis
- NCT number
- NCT05781113
What you commit to
- Study type: Observational
- Planned participants: 90
- From 1 Jul 2023 to the primary completion date, 1 Nov 2026
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| The Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.