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

NCT ID: NCT04882904

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-25
• Study Completion Date: 2026-12-31

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with ALS

Patient with amyotrophic lateral sclerosis

Group Type: EXPERIMENTAL

Actimyo°

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SYSNAV

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Régional de la Citadelle

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role: lead

Responsible Party

Laurent Servais

Coordinator of reference center for neuromuscular diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaux Poleur, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Citadelle-CHU liège

Locations

CHR Citadelle

Liège, Liège, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Laurie MEDARD

Role: CONTACT

Laurie.Medard@citadelle.be

43218222 ext. 0032

Facility Contacts

Laurie MEDARD

Role: primary

Laurie.Medard@citadelle.be

43218222 ext. 0032

Other Identifiers

ActiLiège. ActiSLA part.

Identifier Type: -

Identifier Source: org_study_id