Skip to main content
OpenTrials
Completed

NCT Number: NCT04888689

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

ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. We plan to include a group of approximately 20 patients with MS.

This study include a unique evaluation in the laboratory of analysis of human movement. A set of tasks will be performed by patients wearing of two magneto-inertial sensors.

Completed

Looking for future studies?

Notify Me

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

Centre Hospitalier Régional de la Citadelle

Liège, 4000, Belgium

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.

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.

IMU

Device

IMU is a portable system of miniaturized inertial sensors for objective, instrumental, ambulatory, and validated analysis of normal and pathological human gait. Each miniaturized inertial sensor (2 cm × 0.7 cm × 0.5 cm) includes a triaxial accelerometer and a triaxial gyroscope.

These four inertial sensors are connected to a box by wires and are numbered 1 to 4. They must be attached - using adhesive tapes - on the participant's shoes.

Primary outcomes

  1. 95th centile of stride velocity

    Time frame: One day

    95th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).

  2. 50th centile of stride velocity

    Time frame: One day

    50th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).

  3. 95th centile of stride length

    Time frame: One day

    95th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).

  4. 50th centile of stride length

    Time frame: One day

    50th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).

  5. Stance phase time

    Time frame: One day

    Stance time over full stride time for each foot obtained with magneto-inertial sensors and a motion capture device (percentage).

Sponsors and collaborators

Lead sponsor

Laurent Servais

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: Controlled Environment.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 17, 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.

Related clinical trials

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