Comprehensive Rehabilitation Programme in People With Multiple Sclerosis: The RECONNECT-MS Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCharles University, Czech Republic

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Individual Physiotherapy
  • Group Movement Awareness
  • Group Psychotherapy
  • Nutritional Recommendations

Treatment groups

45 Participants
are divided into 1 treatment group

Sponsors and collaborators

Charles University, Czech Republic

Lead sponsor

Institute for Clinical and Experimental Medicine

Collaborator

Faculty Hospital Kralovske Vinohrady

Collaborator

Czech Ministry of Education

Collaborator