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

Study Overview
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Brief Summary
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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.

Official Title
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Holter of Movement in Patients With Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Actimyo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: all patients undergo clinical evaluation and wear Actimyo device in daily living to assess their gait and its evolution.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MS patients<br>Ambulant patients with multiple sclerosis | Device: Actimyo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actimyo, Accelerometry, Home monitoring