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NCT07666958
Comprehensive Rehabilitation Programme in People With Multiple Sclerosis: The RECONNECT-MS Study
Conditions: Multiple Sclerosis
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 45
Sponsor: Charles University, Czech Republic
Location: University Hospital Kralovske Vinohrady, Department od Rehabilitation Medicine Prague Czech Republic
Summary
The goal of this clinical trial is to learn if a comprehensive rehabilitation programme can improve physical function, reduce fatigue, and raise quality of life in adults aged 18-65 with multiple sclerosis (MS). The study will also look at whether the programme leads to changes in brain function using magnetic resonance imaging (MRI). The main questions it aims to answer are:
* Does the programme lower the overall impact of MS on daily life?
* Does the programme improve walking, balance, and hand function?
* Does the programme reduce the impact of fatigue?
* Are there changes in brain connections after the programme?
Each participant serves as their own comparison. They are tested 3 times: 2 months before the programme starts (T0), right before it starts (T1), and after 2 months of intensive treatment (T2). The period between T0 and T1, when no treatment is given, shows each person's natural changes over time.
Participants will:
* Attend individual physiotherapy twice a week for 2 months, then 3 follow-up sessions over the next month
* Take part in 3 group movement-awareness sessions
* Take part in 3 group psychotherapy sessions focused on stress management and relaxation
* Receive written nutritional guidance for autoimmune conditions
Tests include physical assessments, questionnaires about fatigue and quality of life, tremor measurement, and brain MRI scans.
The results may help improve rehabilitation care for people with MS and support their ability to stay active in everyday and working life.
Eligibility Criteria
Inclusion Criteria:
* Unambiguous clinical diagnosis of multiple sclerosis (any subtype, including relapsing-remitting, secondary progressive, and primary progressive)
* Age 18-65 years
* Predominantly motor disability with Expanded Disability Status Scale (EDSS) 2-6
* No relapse within the past month
* Able to attend outpatient physiotherapy regularly and motivated to participate in the programme
* Able and willing to complete 3 sets of clinical examinations and 3 MRI examinations
Exclusion Criteria:
* Conditions impairing mobility (e.g., severe injuries, orthopaedic problems, other neurological conditions)
* Acute inflammatory conditions or infections at the time of programme initiation that could affect the results or safety of the participant
* Change or planned change of treatment (including disease-modifying therapy or corticosteroid therapy) within the past month or during the programme
* Contraindications to MRI examination (e.g., first-trimester pregnancy, presence of a pacemaker, defibrillator, older metallic joint replacements, or other metallic implants)
* Long-term planned absence during the programme (e.g., holiday, surgical procedure)
Source: ClinicalTrials.gov (NCT07666958). StuddyBuddy aggregates publicly available trial information.