Amyotrophic Lateral Sclerosis
Conditions
Keywords
Actimyo, Accelerometry, Daily living
Brief summary
ActiALS is a multicentric academic study. Patients with amyotrophic lateral sclerosis (ALS) may be included on a voluntary basis. The investigators plan to include a group of approximately 30 patients with ALS. The investigators have planned to assess patient every three months for a year. After each visit, participants will wear Actimyo for one month daily.
Detailed description
On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores. Participants will perform few tests (6-minutes walk test (6MWT), dynamometric measure, electromyography, and will answer to some questionaires (dysphagia handicap scale, Revised Amyotrophic Lateral Sclerosis Functional Rating Scale). 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.
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 Universitaire de Liege
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
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 |
|---|---|---|
| Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point | 1 year | 95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second). |
| Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point | 1 year | 50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second). |
| Difference in 95th centile of stride length between baseline and one year follow up- or last time point | 1 year | 95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter). |
| Difference in 50th centile of stride length between baseline and one year follow up- or last time point | 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, Egypt
Contacts
Primary ContactLaurie Medard
Backup ContactMargaux Poleur, MD
Outcome results
None listed