NCT04882891

Holter of Movement in Patients with Multiple Sclerosis in Uncontrolled Environment.

Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Liege · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 80 patients with MS, fulfilling the McDonald's 2017 criteria, of whom 40 of them show a progressive course according to the Lublin classification. The investigators have planned two visits (at baseline and 1 year later). On both visits, participants will perform few tests (timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPG), 6-minutes walk test (6MWT), Berg balance scale) and will answer to some questionaires (Godin Leisure Time Exercice Questionnaire, multiple sclerosis walking scale, modified fatigue impact scale, Hospital Anxiety and Depression Scale) After each visit, participants will wear Actimyo for three months in daily living.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Actimyo	Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.

Timeline

• Start date: 2021-03-09
• Primary completion: 2026-02-15
• Completion: 2026-02-15
• First posted: 2021-05-12
• Last updated: 2025-02-12

Locations

7 sites across 2 countries: Belgium, France