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Holter of Movement in Patients with Multiple Sclerosis in Uncontrolled Environment. (ActiMS)

U

University Hospital Center (CHU) of Liege

Status

Active, not recruiting

Conditions

Multiple Sclerosis

Treatments

Device: Actimyo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04882891
ActiMS - uncontrolled

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.
  • 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

MS patients
Experimental group
Description:
Ambulant patients with multiple sclerosis
Treatment:
Device: Actimyo

Trial contacts and locations

7

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Central trial contact

Laurie Medard

Data sourced from clinicaltrials.gov

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