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Clinical Trials in the UK / NCT05781113
Active, not recruiting Observational

A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Condition

NCT05781113 · tracked via the Priya Life Science UK tracker
Sponsor
Celestra Health Systems
Phase
Observational
Started
2023-07-01
Last updated
2026-03-20

Condition(s) studied

Multiple Sclerosis

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Participant Adherence — 6 months
    To measure participant adherence, with respect to the wearable smart insoles and the associated smart phone app, for the purpose of MS disease monitoring. Adherence is defined as the collection by the participant of 15-minute walking samples 3x per week using the smart insoles and the associated smart phone app. Adherence will be assessed by calculating the number of tasks completed divided by the number of tasks prompted. \> 80% is deemed high adherence.
  • Clinician Acceptance — 6 months
    To measure clinician acceptance of the solution, by confirming that the results are readily interpretable and useful to the clinician. Specifically, we will measure the satisfaction of clinicians using a 5-point Likert scale, as follows: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied.

Trial sites (3)

FacilityCityRegionStatus
Brigham and Women's Hospital Boston Massachusetts
The Ottawa Hospital Ottawa Ontario
The Royal London Hospital London United Kingdom

Other trials for the same condition

Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis Active, not recruiting
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) Active, not recruiting
An Open-label Study of AZD0120 in Adults With Multiple Sclerosis Recruiting
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS) Recruiting
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05781113 on ClinicalTrials.gov ↗ ← All trials in the UK