Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.
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|ClinicalTrials.gov Identifier: NCT04882904|
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : May 12, 2021
ActiSEP 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 45 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.
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Device: Actimyo°||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients undergo clinical evaluation and wear Actimyo device in daily living to evaluate their evolution.|
|Masking:||None (Open Label)|
|Official Title:||Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects|
|Actual Study Start Date :||September 25, 2020|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: Patient with ALS
Patient with amyotrophic lateral sclerosis
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.
- 95th centile of stride velocity [ Time Frame: 1 year ]95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
- 50th centile of stride velocity [ Time Frame: 1 year ]50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
- 95th centile of stride length [ Time Frame: 1 year ]95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
- 50th centile of stride length [ Time Frame: 1 year ]50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
- Upper limb function evolution in patient with ALS [ Time Frame: 1 year ]Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04882904
|Contact: Laura Buscemi||43215584 ext 0032||Laura.Buscemi@chrcitadelle.be|
|Liège, Belgium, 4000|
|Contact: Laura Buscemi 43215584 ext 0032 Laura.Buscemi@chrcitadelle.be|
|Principal Investigator:||Margaux Poleur, MD||CHR Citadelle-CHU liège|