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Clinical Trials/NCT04888689
NCT04888689CompletedNot Applicable

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

Laurent Servais1 site in 1 country21 target enrollmentStarted: February 4, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
21
Locations
1
Primary Endpoint
95th centile of stride length

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

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

Arms & Interventions

MS patients

Experimental

Ambulant patients with multiple sclerosis

Intervention: Actimyo° (Device)

MS patients

Experimental

Ambulant patients with multiple sclerosis

Intervention: IMU (Device)

Outcomes

Primary Outcomes

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).

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).

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).

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).

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Laurent Servais
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Laurent Servais

Principal investigator

Centre Hospitalier Universitaire de Liege

Study Sites (1)

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