Holter of Movement in Patients with Multiple Sclerosis in Uncontrolled
Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.
What it found
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
Started
Mar 2021
Main results due
Feb 2026
Finished
Feb 2026