Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Actimyo.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Actimyo
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.
Primary outcome measures
- Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point [Time frame: 1 year]
- Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point [Time frame: 1 year]
- Difference in 95th centile of stride length between baseline and one year follow up- or last time point [Time frame: 1 year]
- Difference in 50th centile of stride length between baseline and one year follow up- or last time point [Time frame: 1 year]
Secondary outcome measures (1)
- Upper limb function evolution in patient with ALS [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 2 centers
- Katholieke Universiteit Leuven — Leuven
- Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citade — Liège
Egypt · 1 center
- Galaa Military Medical Complex — Cairo
Identifiers
NCT: NCT06228001 · ActiALS study