NCT04882891Active, not recruiting
Holter of Movement in Patients with Multiple Sclerosis in Uncontrolled Environment.
Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.
Source: ClinicalTrials.gov · Last updated 12 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 11 Mar 2021
- Start date
- 9 Mar 2021
- Primary completion date
- 15 Feb 2026
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Diseases
- Multiple sclerosis
- NCT number
- NCT04882891
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 9 Mar 2021 to the primary completion date, 15 Feb 2026
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerp University Hospital Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| CHC Mont Légia Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| CHR Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Saint-Luc University Clinics Coordinator of this site? Confirm its status | Woluwe-St. Lambert | Belgium | Unknown status |
| Hopital D Instruction Des Armées Percy Coordinator of this site? Confirm its status | Clamart | France | Unknown status |
| Pitié Salpêtrière Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.