Study Purpose:
ActiSEP 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 45 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 Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
Actimyo°
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Margaux Poleur, MD, CHR Citadelle-CHU liège
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Laura Buscemi / email hidden; JavaScript is required / 43215584
Study Sponsor:
Dr. Stéphanie Delstanche
Estimated Enrollment:
45
Estimated Study Start Date:
09 / 25 / 2020
Estimated Study Completion Date:
09 / 01 / 2023
Posting Last Modified Date:
05 / 12 / 2021
Date Study Added to neals.org:
05 / 12 / 2021
Minimum Age:
18 Years
Maximum Age:
N/A
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.
CHR Citadelle | Recruiting
Laura Buscemi / 43215584 Ext. 0032 / email hidden; JavaScript is required
Liège 4000
Belgium