Amyotrophic Lateral Sclerosis
Conditions
Keywords
Actimyo, Accelerometry, Daily living
Brief summary
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.
Interventions
DEVICEActimyo°
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.
Sponsors
SYSNAV
Centre Hospitalier Régional de la Citadelle
Centre Hospitalier Universitaire de Liege
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All patients undergo clinical evaluation and wear Actimyo device in daily living to evaluate their evolution.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 95th centile of stride velocity | 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 | 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 | 1 year | 95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter). |
| 50th centile of stride length | 1 year | 50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper limb function evolution in patient with ALS | 1 year | Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life. |
Countries
Belgium
Contacts
Primary ContactLaurie MEDARD
Outcome results
None listed