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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Actimyo°
IMU
Sponsored by
Dr. Stéphanie Delstanche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Actimyo, Accelerometry, Motion laboratory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Régional de la Citadelle
  • Laboratoire d'Analyse du Mouvement Humain

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MS patients

Arm Description

Ambulant patients with multiple sclerosis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 11, 2021
Last Updated
October 6, 2023
Sponsor
Dr. Stéphanie Delstanche
Collaborators
Sysnav, Centre Hospitalier Universitaire de Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04888689
Brief Title
Holter of Movement in Patients With Multiple Sclerosis in Controlled Environment.
Official Title
Holter of Movement in Patients With Multiple Sclerosis. Acti-SEP Study: Controlled Environment.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Stéphanie Delstanche
Collaborators
Sysnav, Centre Hospitalier Universitaire de Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Actimyo, Accelerometry, Motion laboratory

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all patients undergo clinical evaluation while wearing Actimyo device to assess their gait.
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MS patients
Arm Type
Experimental
Arm Description
Ambulant patients with multiple sclerosis
Intervention Type
Device
Intervention Name(s)
Actimyo°
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
IMU
Intervention Description
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 Outcome Measure Information:
Title
95th centile of stride velocity
Description
95th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
Time Frame
One day
Title
50th centile of stride velocity
Description
50th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
Time Frame
One day
Title
95th centile of stride length
Description
95th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
Time Frame
One day
Title
50th centile of stride length
Description
50th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
Time Frame
One day
Title
Stance phase time
Description
Stance time over full stride time for each foot obtained with magneto-inertial sensors and a motion capture device (percentage).
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaux Poleur, MD
Organizational Affiliation
CHR Citadelle-CHU liège
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Laboratoire d'Analyse du Mouvement Humain
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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