Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects

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:

NCT04882904

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