Multiple Sclerosis
Conditions
Keywords
Digital Health Technology
Brief summary
The study aims to assess the validity of real-world activity monitoring by the Syde® wearable device in subjects with multiple slclerosis. The Syde® collected data will be compared to on-site conventional clinical endpoints for MS pathology (EDSS, FSS and T25FWT). Subjects with multiple sclerosis will be assessed every 6 months for 2 years.
Interventions
OTHERDigital HealthTechnology
Subject will wear the Syde® for 1 month every 6 months
Sponsors
SYSNAV
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
1. Male or female subject aged from 18 to 65 years old. 2. Signed informed consent and ability to comply with study and follow-up. 3. Diagnosed with MS base on 2017 McDonald criterion 4. EDSS ≤ 5.5 5. No clinical or radiological relapse within the last 3 months 6. For patient under treatment, the molecule and its dose should be stable about 2 months before inclusion 7. Subject willing and able to comply to all study procedures including the Syde® related ones
Exclusion criteria
1. Patient with a cognitive or communicational disorder disturbing the understanding of the tasks or data collection 2. Previous or current disorder with an impact on current ambulation or motor function 3. Patient who have had surgery or traumatic injury in upper or lower limb within the last 6 months before the inclusion or patients who have had major surgery or trauma within the last 6 months before the inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal change of 95th centile of stride velocity | 2 years | change between baseline and Month 6, Month 12, Month 18 and Month 24 |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT | 2 years |
Countries
Egypt
Outcome results
None listed