NCT04882891

Brief Summary

ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 80 patients with MS, fulfilling the McDonald's 2017 criteria, of whom 40 of them show a progressive course according to the Lublin classification. The investigators have planned two visits (at baseline and 1 year later). On both visits, participants will perform few tests (timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPG), 6-minutes walk test (6MWT), Berg balance scale) and will answer to some questionaires (Godin Leisure Time Exercice Questionnaire, multiple sclerosis walking scale, modified fatigue impact scale, Hospital Anxiety and Depression Scale) After each visit, participants will wear Actimyo for three months in daily living.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
2 countries

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

February 12, 2025

Status Verified

January 1, 2025

Enrollment Period

4.9 years

First QC Date

March 11, 2021

Last Update Submit

February 10, 2025

Conditions

Multiple Sclerosis

Keywords

ActimyoAccelerometryHome monitoring

Outcome Measures

Primary Outcomes (5)

  • 95th centile of stride velocity

    95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

    1 year

  • 50th centile of stride velocity

    50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

    1 year

  • 95th centile of stride length

    95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

    1 year

  • 50th centile of stride length

    50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

    1 year

  • Stance phase time

    Stance time over full stride time for each foot obtained with a magneto-inertial sensor (Actimyo°) in real-life (percentage).

    1 year

Study Arms (1)

MS patients

EXPERIMENTAL

Ambulant patients with multiple sclerosis

Device: Actimyo

Interventions

ActimyoDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • EDSS \< or = à 5,5,

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre Hospitalier Universitaire de Liège

Liège, Liège, 4000, Belgium

Location

CHR Citadelle

Liège, Liège, 4000, Belgium

Location

Antwerp University Hospital

Antwerp, 2000, Belgium

Location

CHC Mont Legia

Liège, 4000, Belgium

Location

Saint-Luc University Clinics

Woluwe-St. Lambert, 1200, Belgium

Location

Hôpital d'instruction des Armées Percy

Clamart, 91240, France

Location

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune 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
Model Details: all patients undergo clinical evaluation and wear Actimyo device in daily living to assess their gait and its evolution.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2021

First Posted

May 12, 2021

Study Start

March 9, 2021

Primary Completion

February 15, 2026

Study Completion

February 15, 2026

Last Updated

February 12, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)BE(5)