Measuring daily activity in patients with ALS and healthy controls
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects
NA · Centre Hospitalier Universitaire de Liege · NCT04882904
This study is testing how active people with ALS are compared to healthy individuals by using a special device to track their daily movements over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Liege (other) |
| Locations | 1 site (Liège, Liège) |
| Trial ID | NCT04882904 on ClinicalTrials.gov |
What this trial studies
This study aims to continuously measure the activity levels of patients diagnosed with amyotrophic lateral sclerosis (ALS) and compare them with healthy control subjects. Approximately 20 ALS patients will be enrolled voluntarily and assessed every three months over a year. Participants will undergo various clinical examinations and tests, including the 6-minute walk test and electromyography, and will wear a device called Actimyo daily for one month to monitor their activity levels. The study seeks to gather comprehensive data on the daily living activities of ALS patients to better understand the disease's impact.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a clinically defined or probable diagnosis of ALS.
Not a fit: Patients with significant cognitive disorders or other pathologies affecting motor function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the daily activity patterns of ALS patients, potentially leading to improved management strategies.
How similar studies have performed: While similar studies have explored activity measurement in ALS, this specific approach using continuous monitoring with Actimyo is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Liège, Liège
- CHR Citadelle — Liège, Liège, Belgium (RECRUITING)
Study contacts
- Principal investigator: Margaux Poleur, MD — CHR Citadelle-CHU liège
- Study coordinator: Laurie MEDARD
- Email: Laurie.Medard@citadelle.be
- Phone: 43218222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amyotrophic Lateral Sclerosis, Actimyo, Accelerometry, Daily living