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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04882891
• Other study ID #: ActiSEP. Part 2.
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: February 15, 2026

Study information

• Verified date: April 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: February 15, 2026
• Est. primary completion date: February 15, 2026
• 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.
• EDSS < or = à 5,5,
• Treated patient must be on a stable regimen dose and molecule for at least 2 month prior to inclusion.

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.

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Belgium	CHR Citadelle	Liège

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Liege	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 a magneto-inertial sensor (Actimyo°) in real-life (meter per second).	1 year
Primary	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
Primary	95th centile of stride length	95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).	1 year
Primary	50th centile of stride length	50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).	1 year
Primary	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