Novel Wearable MS Digital Biomarker
Research type
Research Study
Full title
A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Disease Condition through Home Monitoring of MS Patients
IRAS ID
326384
Contact name
Sharmilee Gnanapavan
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research 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 Multiple Sclerosis (MS) patients’ condition on a day-to-day basis.
Over the study period we will be measuring adherence to the tasks on the app and ease of use/safety, as well as usefulness to the clinician; measuring changes in gait patterns whether there is improvement, stability or worsening; and testing cognitive function and finger manual dexterity using the smart phone app thereby providing a comprehensive assessment of the MS.
The study is a single-centre study (Barts Health NHS Trust), 30 participants will be recruited from Barts Health. Participants will use the insoles and smart app for 6 months and then 10 participants will complete a further 6 months.
REC name
West of Scotland REC 5
REC reference
23/WS/0162
Date of REC Opinion
23 Nov 2023
REC opinion
Further Information Favourable Opinion