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
Celestra Health Systems
90 participants
Jul 1, 2023
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
Inclusion Criteria4
- 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 Criteria2
- 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.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05781113