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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: Actimyo°; Device: IMU

• Registration Number: NCT04888689
• Lead Sponsor: Laurent Servais

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-04
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MS patients	Actimyo°	Ambulant patients with multiple sclerosis
MS patients	IMU	Ambulant patients with multiple sclerosis

Primary Outcome Measures

Name	Time	Method
95th centile of stride velocity	One day	95th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
50th centile of stride velocity	One day	50th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
Stance phase time	One day	Stance time over full stride time for each foot obtained with magneto-inertial sensors and a motion capture device (percentage).
95th centile of stride length	One day	95th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
50th centile of stride length	One day	50th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).

Trial Locations

Locations (1)

Centre Hospitalier Régional de la Citadelle; 🇧🇪 Liège, Belgium