Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06228001

Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Katholieke Universiteit Leuven, Leuven, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point

    Time frame: 1 year

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

  2. Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point

    Time frame: 1 year

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

  3. Difference in 95th centile of stride length between baseline and one year follow up- or last time point

    Time frame: 1 year

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

  4. Difference in 50th centile of stride length between baseline and one year follow up- or last time point

    Time frame: 1 year

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

Secondary outcomes

  1. Upper limb function evolution in patient with ALS

    Time frame: 1 year

    Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurie Medard

CONTACT

[email protected]

+3243218222

Margaux Poleur, MD

CONTACT

[email protected]

+3243216127

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Liege

Other

Collaborators

  • SYSNAV

Registry information

Acronym: ActiALS

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 29, 2024
Registry last updated
May 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.