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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06346704
Other study ID # PR5030-66
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 25, 2024
Est. completion date November 30, 2026

Study information

Verified date May 2024
Source SYSNAV
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 61
Est. completion date November 30, 2026
Est. primary completion date November 30, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Digital HealthTechnology
Subject will wear the Syde® for 1 month every 6 months

Locations

Country Name City State
Egypt Air Force Specialized Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
SYSNAV

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Longitudinal change of 95th centile of stride velocity change between baseline and Month 6, Month 12, Month 18 and Month 24 2 years
Secondary Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT 2 years
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