CClinicalTrials.gg
RecruitingNCT04882904Updated Dec 5, 2025

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

An interventional study of Actimyo° in Amyotrophic Lateral Sclerosis, sponsored by Centre Hospitalier Universitaire de Liege. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Centre Hospitalier Universitaire de Liege · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2020, registered Mar 2021).
  • Started Sep 2020; still recruiting 6 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • Actimyo
  • Accelerometry
  • Daily living
03

In context

Amyotrophic Lateral Sclerosis

981 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 282 are open to participants now.

This study's planned enrollment of 45 is above the median of 36 across 667 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

Centre Hospitalier Universitaire de Liege is the lead sponsor of 37 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Patient with ALS

    Patient with amyotrophic lateral sclerosis

    Device: Actimyo°

Interventions

  • DeviceActimyo°

    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.

06

What researchers measure

Primary outcomes

  1. 95th centile of stride velocity

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

    Time frame: 1 year

  2. 50th centile of stride velocity

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

    Time frame: 1 year

  3. 95th centile of stride length

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

    Time frame: 1 year

  4. 50th centile of stride length

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

    Time frame: 1 year

Secondary outcomes

  1. Upper limb function evolution in patient with ALS

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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04882904
Lead sponsor
Centre Hospitalier Universitaire de Liege
Collaborators
SYSNAV, Centre Hospitalier Régional de la Citadelle
Responsible party
Laurent Servais (Coordinator of reference center for neuromuscular diseases, Centre Hospitalier Universitaire de Liege) — Principal investigator
First posted
May 12, 2021
Start date
Sep 25, 2020
Primary completion
Sep 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 5, 2025

Study contacts

Laurie MEDARD
Contact
Laurie.Medard@citadelle.be
43218222 ext. 0032
Margaux Poleur, MD
principal investigator · CHR Citadelle-CHU liège

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion