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

NCT04888689 | Completed

• 1 other identifier: ActiSEP. Part 1.
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Actimyo; Accelerometry; Motion laboratory

Outcome Measures

Primary Outcomes (5)

• 95th centile of stride velocity

  95th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).

  One day

• 50th centile of stride velocity

  50th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).

  One day

• 95th centile of stride length

  95th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).

  One day

• 50th centile of stride length

  50th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).

  One day

• 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

Study Arms (1)

MS patients

EXPERIMENTAL

Ambulant patients with multiple sclerosis

Device: Actimyo°; Device: IMU

Interventions

Actimyo° 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.

MS patients

IMU 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.

MS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed MS diagnosis,
• Over 18 years old,
• Ambulant patients,
• Signed informed consent,
• No clinical and / or radiological relapse within 3 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laurent Servais: lead
• SYSNAV: collaborator
• Centre Hospitalier Régional de la Citadelle: collaborator

Study Sites (1)

Centre Hospitalier Régional de la Citadelle

Liège, Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Margaux Poleur, MD

  CHR Citadelle-CHU liège

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: all patients undergo clinical evaluation while wearing Actimyo device to assess their gait.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: May 17, 2021
• Study Start: February 4, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)