Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.

Study Overview
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Brief Summary
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ActiSLA is a monocentric academic study. Patients with amyotrophic lateral sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 20 patients with ALS. The investigators have planned to assess patient every three months for a year. On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores. They will perform few tests ( 6-minutes walk test (6MWT), dynamometric measure, electromyography, Edinburgh Cognitive and Behavioural ALS Screen ) and will answer to some questionaires (dysphagia handicap scale, ALS-SFR-r). After each visit, participants will wear Actimyo for one month daily.

Official Title
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Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Device: Actimyo°


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically defined or probable diagnosis of ALS according to El Escorial criteria revised with Awaji's electro-diagnostic algorithm. Over 18 years old. Signed informed consent If patient on Riluzole, the dosage should be stable for 1 month and continued throughout the study period. 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. Prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion. Patients participating in an interventional clinical trial.

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All patients undergo clinical evaluation and wear Actimyo device in daily living to evaluate their evolution.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with ALS<br>Patient with amyotrophic lateral 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb function evolution in patient with ALS | Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actimyo, Accelerometry, Daily living