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Active, not recruitingNCT04882891ActiMSUpdated Feb 12, 2025

Holter of Movement in Patients with Multiple Sclerosis in Uncontrolled Environment.

An interventional study of Actimyo in Multiple Sclerosis, sponsored by Centre Hospitalier Universitaire de Liege. Active, not recruiting at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.

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

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 80 patients with MS, fulfilling the McDonald's 2017 criteria, of whom 40 of them show a progressive course according to the Lublin classification.

The investigators have planned two visits (at baseline and 1 year later). On both visits, participants will perform few tests (timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPG), 6-minutes walk test (6MWT), Berg balance scale) and will answer to some questionaires (Godin Leisure Time Exercice Questionnaire, multiple sclerosis walking scale, modified fatigue impact scale, Hospital Anxiety and Depression Scale) After each visit, participants will wear Actimyo for three months in daily living.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Actimyo
  • Accelerometry
  • Home monitoring
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple 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.

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Who can participate

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

Inclusion criteria

  • Confirmed MS diagnosis,
  • Over 18 years old,
  • Ambulant patients,
  • Signed informed consent,
  • No clinical and / or radiological relapse within 3 months.
  • EDSS \< or = à 5,5,
  • Treated patient must be on a stable regimen dose and molecule for at least 2 month prior to inclusion.

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
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Study design

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

Study arms

  • Experimental
    MS patients

    Ambulant patients with multiple 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

  5. Stance phase time

    Stance time over full stride time for each foot obtained with a magneto-inertial sensor (Actimyo°) in real-life (percentage).

    Time frame: 1 year

07

Study locations

7 sites
  • Antwerp University Hospital
    Antwerp, 2000, Belgium
  • CHC Mont Legia
    Liege, 4000, Belgium
  • Centre Hospitalier Universitaire de Liège
    Liège, 4000, Belgium
  • CHR Citadelle
    Liège, 4000, Belgium
  • Saint-Luc University Clinics
    Woluwe-St. Lambert, 1200, Belgium
  • Hôpital d'instruction des Armées Percy
    Clamart, 91240, France
  • Pitié-Salpêtrière Hospital
    Paris, 75013, France
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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 Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04882891
Lead sponsor
Centre Hospitalier Universitaire de Liege
Collaborators
SYSNAV, Centre Hospitalier Régional de la Citadelle
Responsible party
Laurent Servais (Professor, Centre Hospitalier Universitaire de Liege) — Principal investigator
First posted
May 12, 2021
Start date
Mar 9, 2021
Primary completion
Feb 15, 2026 (estimated)
Completion
Feb 15, 2026 (estimated)
Last update
Feb 12, 2025

Study contacts

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 ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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