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

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

NCT04882891 · tracked via the Priya Life Science Belgium 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 Belgium

Treatment Preventive for Pre-eclampsia by Acetylsalicylic Acid in Women Who Underwent Frozen Embryo Transfer Recruiting
Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study Recruiting
Natural History Study for Patients With Nemaline Myopathy in Belgium Starting soon
Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility. Recruiting
Selective Versus Contiguous Connective Tissue Grafts in the Modified Tunnel Technique Recruiting

Other trials for the same condition

Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA) Active, not recruiting
A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2) Active, not recruiting
Prognostic Value of Cerebrospinal Fluid Immunoglobulin Free Light Chains in Patients With Multiple Sclerosis Recruiting
Walking Fatigability and Brain Activity in People With Multiple Sclerosis Active, not recruiting
Remote MS Care in Antwerp 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 Belgium