Clinical trial NCT04882891: Holter of Movement in Patients with Multiple Sclerosis in Uncontrolled Environment.
Official title: Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Actimyo
Accelerometry
Home monitoring
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
Collaborators: name: SYSNAV
name: Centre Hospitalier Régional de la Citadelle
First posted: 2021-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all patients undergo clinical evaluation and wear Actimyo device in daily living to assess their gait and its evolution.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 95th centile of stride velocity
timeFrame: 1 year
measure: 50th centile of stride velocity
timeFrame: 1 year
measure: 95th centile of stride length
timeFrame: 1 year
measure: 50th centile of stride length
timeFrame: 1 year
measure: Stance phase time
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
city: Liege
country: Belgium
facility: CHC Mont Legia
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Liège
country: Belgium
facility: CHR Citadelle
city: Woluwe-St. Lambert
country: Belgium
facility: Saint-Luc University Clinics
city: Clamart
country: France
facility: Hôpital d'instruction des Armées Percy
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
Study officials:
affiliation: CHR Citadelle-CHU liège
name: Margaux Poleur, MD
role: PRINCIPAL_INVESTIGATOR
References: