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

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Device: Actimyo°

• Registration Number: NCT04882904
• Lead Sponsor: Centre Hospitalier Universitaire de Liege

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-25
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with ALS	Actimyo°	Patient with amyotrophic lateral sclerosis

Primary Outcome Measures

Name	Time	Method
95th centile of stride length	1 year	95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
95th centile of stride velocity	1 year	95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
50th centile of stride velocity	1 year	50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
50th centile of stride length	1 year	50th 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 (1)

CHR Citadelle; 🇧🇪 Liège, Belgium