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

Running, not recruitingNot a drug-phase studyMS (type not specified)NCT04882891

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Actimyo

What it measured

Main measures

  • 95th centile of stride velocity

    1 year

  • 50th centile of stride velocity

    1 year

  • 95th centile of stride length

    1 year

  • 50th centile of stride length

    1 year

  • Stance phase time

    1 year

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Mar 2021

      2. Main results due

        Feb 2026

      3. Finished

        Feb 2026

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