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

NCT04882904 | Recruiting

• 1 other identifier: ActiLiège. ActiSLA part.
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Actimyo; Accelerometry; Daily living

Outcome Measures

Primary Outcomes (4)

• 95th centile of stride velocity

  95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

  1 year

• 50th centile of stride velocity

  50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

  1 year

• 95th centile of stride length

  95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

  1 year

• 50th centile of stride length

  50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

  1 year

Secondary Outcomes (1)

• Upper limb function evolution in patient with ALS

  1 year

Study Arms (1)

Patient with ALS

EXPERIMENTAL

Patient with amyotrophic lateral sclerosis

Device: Actimyo°

Interventions

Actimyo° 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.

Patient with ALS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients participating in an interventional clinical trial.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead
• SYSNAV: collaborator
• Centre Hospitalier Régional de la Citadelle: collaborator

Study Sites (1)

CHR Citadelle

Liège, Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Margaux Poleur, MD

  CHR Citadelle-CHU liège

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie MEDARD

CONTACT

43218222; Laurie.Medard@citadelle.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of reference center for neuromuscular diseases

Model Details: All patients undergo clinical evaluation and wear Actimyo device in daily living to evaluate their evolution.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: May 12, 2021
• Study Start: September 25, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)