Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- 50th centile of stride velocity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Patient with ALS
Patient with amyotrophic lateral sclerosis
Intervention: Actimyo° (Device)
Outcomes
Primary Outcomes
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).
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 length
Time Frame: 1 year
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(1 year)
Investigators
Laurent Servais
Coordinator of reference center for neuromuscular diseases
Centre Hospitalier Universitaire de Liege