Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-25

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Keywords

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Digital Health Technology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Digital HealthTechnology

Subject will wear the Syde® for 1 month every 6 months

Intervention Type OTHER

Other Intervention Names

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Syde®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed Elnemr, MD

Role: PRINCIPAL_INVESTIGATOR

Air Force Specialized Hospital Cairo

Locations

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Air Force Specialized Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PR5030-66

Identifier Type: -

Identifier Source: org_study_id