Multiple Sclerosis Clinical Trial
Official title:
Holter of Movement in Patients With Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.
Verified date | April 2024 |
Source | Centre Hospitalier Universitaire de Liege |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 80 |
Est. completion date | February 15, 2026 |
Est. primary completion date | February 15, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Centre Hospitalier Universitaire de Liège | Liège | |
Belgium | CHR Citadelle | Liège |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Liege | Centre Hospitalier Régional de la Citadelle, SYSNAV |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 95th centile of stride velocity | 95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second). | 1 year | |
Primary | 50th centile of stride velocity | 50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second). | 1 year | |
Primary | 95th centile of stride length | 95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter). | 1 year | |
Primary | 50th centile of stride length | 50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter). | 1 year | |
Primary | Stance phase time | Stance time over full stride time for each foot obtained with a magneto-inertial sensor (Actimyo°) in real-life (percentage). | 1 year |
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