Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT06228001
• Lead Sponsor: Centre Hospitalier Universitaire de Liege

Brief Summary

ActiALS is a multicentric academic study. Patients with amyotrophic lateral sclerosis (ALS) may be included on a voluntary basis. The investigators plan to include a group of approximately 30 patients with ALS.

The investigators have planned to assess patient every three months for a year. After each visit, participants will wear Actimyo for one month daily.

Detailed Description

On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores.

Participants will perform few tests (6-minutes walk test (6MWT), dynamometric measure, electromyography, and will answer to some questionaires (dysphagia handicap scale, Revised Amyotrophic Lateral Sclerosis Functional Rating Scale).

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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-19
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point	1 year	95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Difference in 50th centile of stride length between baseline and one year follow up- or last time point	1 year	50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point	1 year	50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Difference in 95th centile of stride length between baseline and one year follow up- or last time point	1 year	95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

Secondary Outcome Measures

Name	Time	Method
Upper limb function evolution in patient with ALS	1 year	Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life.

Trial Locations

Locations (3)

Katholieke Universiteit Leuven; 🇧🇪 Leuven, Belgium

Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle; 🇧🇪 Liège, Belgium

Galaa Military Medical Complex; 🇪🇬 Cairo, Egypt