Holter of Movement in Patients With Amyotrophic Lateral Sclerosis. (ActiALS)

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Device: Actimyo

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Margaux Poleur, MD; Phone Number: +3243216127; Email: margaux.poleur@citadelle.be
• Study Contact Backup: Name: Laurie Medard; Phone Number: +3243218222; Email: laurie.medard@citadelle.be

Study Locations

• Belgium
  • Leuven, Belgium, 1425
    • Recruiting
    • Katholieke Universiteit Leuven
  • Liège, Belgium, 4000
    • Recruiting
    • Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
    • Principal Investigator: Stephanie Delstanche
    • Contact: Laurie Médard; Phone Number: 043218222; Email: Laurie.Medard@citadelle.be
• Egypt
  • Cairo, Egypt
    • Active, not recruiting
    • Galaa Military Medical Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with amyotrophic lateral sclerosis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Liege
• Collaborators: SYSNAV
• Investigators: Principal Investigator: Stéphanie Delstanche, MD, Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Accelerometry; Actimyo; Daily living
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: ActiALS study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No