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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888689
• Other study ID #: ActiSEP. Part 1.
• Status: Completed
• Phase: N/A
• Start date: February 4, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Régional de la Citadelle	Liège
Belgium	Laboratoire d'Analyse du Mouvement Humain	Liège

Sponsors (3)

Lead Sponsor	Collaborator
Laurent Servais	Centre Hospitalier Régional de la Citadelle, SYSNAV

Country where clinical trial is conducted

Belgium, 

Outcome

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