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Active, Not Recruiting

NCT Number: NCT04882891

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Citadelle, Liège, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

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. 95th centile of stride velocity

    Time frame: 1 year

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

  2. 50th centile of stride velocity

    Time frame: 1 year

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

  3. 95th centile of stride length

    Time frame: 1 year

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

  4. 50th centile of stride length

    Time frame: 1 year

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

  5. Stance phase time

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Liege

Other

Collaborators

  • Centre Hospitalier Régional de la Citadelle
  • SYSNAV

Registry information

Official study title

Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.

Acronym: ActiMS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 12, 2021
Registry last updated
Feb 12, 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.

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