CHR Citadelle
Liège, 4000, Belgium
Location status: Recruiting
Recruiting
NCT Number: NCT04882904
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
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.
Primary outcomes
-
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).
Secondary outcomes
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire de Liege
Other
Collaborators
- Centre Hospitalier Régional de la Citadelle
- SYSNAV
Registry information
Official study title
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects
Important dates
- Study start
- 2020
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 12, 2021
- Registry last updated
- Dec 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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