NCT04882904 Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.
| NCT ID | NCT04882904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Liege |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2020-09-25 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2020-09-25 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Margaux Poleur, MD
PRINCIPAL INVESTIGATOR
CHR Citadelle-CHU liège
Frequently Asked Questions
Who can join the NCT04882904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04882904 currently recruiting?
Yes, NCT04882904 is actively recruiting participants. Contact the research team at Laurie.Medard@citadelle.be for enrollment information.
Where is the NCT04882904 trial being conducted?
This trial is being conducted at Liège, Belgium.
Who is sponsoring the NCT04882904 clinical trial?
NCT04882904 is sponsored by Centre Hospitalier Universitaire de Liege. The principal investigator is Margaux Poleur, MD at CHR Citadelle-CHU liège. The trial plans to enroll 45 participants.
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