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Clinical Trials in France / NCT04882891
Active, not recruiting Not applicable

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

NCT04882891 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Liege
Phase
Not applicable
Started
2021-03-09
Last updated
2025-02-12

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Actimyo

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Centre Hospitalier Universitaire de Liège Liège Liège
CHR Citadelle Liège Liège
Antwerp University Hospital Antwerp Belgium
CHC Mont Legia Liège Belgium
Saint-Luc University Clinics Woluwe-St. Lambert Belgium
Hôpital d'instruction des Armées Percy Clamart France
Pitié-Salpêtrière Hospital Paris France

More Centre Hospitalier Universitaire de Liege trials in France

Selective Versus Contiguous Connective Tissue Grafts in the Modified Tunnel Technique Recruiting

Other trials for the same condition

OFSEP Very High Definition Cohort Active, not recruiting
Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis Recruiting
MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis Recruiting
The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology. Recruiting
Grey Matter Damage at the Earliest Phase of Multiple Sclerosis : a Longitudinal 7T MRI Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04882891 on ClinicalTrials.gov ↗ ← All trials in France