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

Not Applicable

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Device: Actimyo

• Registration Number: NCT04882891
• Lead Sponsor: Centre Hospitalier Universitaire de Liege

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-09
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-02-15
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Confirmed MS diagnosis,
• Over 18 years old,
• Ambulant patients,
• Signed informed consent,
• No clinical and / or radiological relapse within 3 months.
• EDSS < or = à 5,5,
• Treated patient must be on a stable regimen dose and molecule for at least 2 month prior to inclusion.

Exclusion Criteria

• Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
• Any other previous or present pathology having an impact on motor function.
• Recent surgery or trauma (less than 6 months) in the upper or lower limbs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MS patients	Actimyo	Ambulant patients with multiple sclerosis

Primary Outcome Measures

Name	Time	Method
95th centile of stride length	1 year	95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
50th centile of stride velocity	1 year	50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
95th centile of stride velocity	1 year	95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Stance phase time	1 year	Stance time over full stride time for each foot obtained with a magneto-inertial sensor (Actimyo°) in real-life (percentage).
50th centile of stride length	1 year	50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

Trial Locations

Locations (7)

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium

CHC Mont Legia; 🇧🇪 Liege, Belgium

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium

CHR Citadelle; 🇧🇪 Liège, Belgium

Saint-Luc University Clinics; 🇧🇪 Woluwe-St. Lambert, Belgium

Hôpital d'instruction des Armées Percy; 🇫🇷 Clamart, France

Pitié-Salpêtrière Hospital; 🇫🇷 Paris, France