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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04888689

Enrollment

Registered

2021-05-17

Start date

2021-02-04

Completion date

2021-09-30

Last updated

2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Actimyo, Accelerometry, Motion laboratory

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.

Interventions

DEVICEActimyo°

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.

DEVICEIMU

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026