RecruitingNCT05781113

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


Sponsor

Celestra Health Systems

Enrollment

90 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable device can detect changes in walking patterns in people with multiple sclerosis (MS). The goal is to validate a digital biomarker — a measurable signal from a wearable — that could track disease progression or treatment response more precisely than standard clinical assessments. **You may be eligible if:** - You have a confirmed diagnosis of multiple sclerosis (MS) and are between 18 and 60 years old - Your disability level is moderate or below (EDSS score ≤6.5) - Your walking pattern falls into one of the following categories: ataxic (uncoordinated), hemiplegic (weakness on one side), or spastic (stiffness) - You may have a progressive form of MS **You may NOT be eligible if:** - Your EDSS disability score is above 6.5 - You do not have a walking impairment in one of the specified categories - You fall outside the age range of 18–60 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Brigham and Women's Hospital

Boston, Massachusetts, United States

The Ottawa Hospital

Ottawa, Ontario, Canada

The Royal London Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05781113


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