About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Actimyo°
DeviceActimyo° 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.
Treatment groups
Trial outcomes
Primary outcomes
95th centile of stride velocity
95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
50th centile of stride velocity
50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
95th centile of stride length
95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
50th centile of stride length
50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
Secondary outcomes
Upper limb function evolution in patient with ALS
Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life.
Sponsors and contacts
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Centre Hospitalier Universitaire de Liege
Lead sponsor
SYSNAV
Collaborator
Centre Hospitalier Régional de la Citadelle
Collaborator