Holter of Movement in Patients With Multiple Sclerosis in Controlled 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. We plan to include a group of approximately 20 patients with MS. This study include a unique evaluation in the laboratory of analysis of human movement. A set of tasks will be performed by patients wearing of two magneto-inertial sensors.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Actimyo°
* Device: IMU


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. 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 while wearing Actimyo device to assess their gait.
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>Device: IMU<br>* IMU is a portable system of miniaturized inertial sensors for objective, instrumental, ambulatory, and validated analysis of normal and pathological human gait. Each miniaturized inertial sensor (2 cm × 0.7 cm × 0.5 cm) includes a triaxial accelerometer and a triaxial gyroscope. These four inertial sensors are connected to a box by wires and are numbered 1 to 4. They must be attached - using adhesive tapes - on the participant's shoes.<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 magneto-inertial sensors and a motion capture device (meter/second). | One day | 
| 50th centile of stride velocity | 50th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second). | One day | 
| 95th centile of stride length | 95th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter). | One day | 
| 50th centile of stride length | 50th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter). | One day | 
| Stance phase time | Stance time over full stride time for each foot obtained with magneto-inertial sensors and a motion capture device (percentage). | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actimyo, Accelerometry, Motion laboratory