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

NCT ID: NCT04888689

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2021-09-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MS patients

Ambulant patients with multiple sclerosis

Group Type: EXPERIMENTAL

Actimyo°

Intervention Type: 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

Intervention Type: 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.

Interventions

Actimyo°

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

IMU

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SYSNAV

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Régional de la Citadelle

OTHER

Sponsor Role: collaborator

Laurent Servais

OTHER

Sponsor Role: lead

Responsible Party

Laurent Servais

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Margaux Poleur, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Citadelle-CHU liège

Locations

Centre Hospitalier Régional de la Citadelle

Liège, Liège, Belgium

Countries

Belgium

Other Identifiers

ActiSEP. Part 1.

Identifier Type: -

Identifier Source: org_study_id