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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Individual Physiotherapy

    Behavioral

    Facilitation-based individual physiotherapy (Motor Programme Activating Therapy, Dynamic Neuromuscular Stabilisation, soft-tissue and mobilisation techniques). 50 minute sessions, twice weekly for 8 weeks, then 3 maintenance sessions at progressively extended intervals during weeks 9-12. Delivered by two alternating physiotherapists.

  • Group Movement Awareness

    Behavioral

    Three small-group sessions (6-8 participants) of Feldenkrais Awareness Through Movement (ATM).

  • Group Psychotherapy

    Behavioral

    Three 60-minute small-group sessions focused on stress management, emotion regulation, relaxation techniques, and psychoeducation.

  • Nutritional Recommendations

    Other intervention

    Written / online evidence-based nutritional recommendations for autoimmune disease.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Comprehensive Rehabilitation ProgrammeExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Change in MS-specific health impact (Multiple Sclerosis Impact Scale, MSIS-29 total score)

The MSIS-29 is a 29-item patient-reported outcome assessing the physical (20 items) and psychological (9 items) impact of multiple sclerosis on daily life over the past 2 weeks. Each item is rated on a 5-point scale; the total score is transformed to a 0-100 metric (higher scores indicate greater impact of MS). MSIS-29 was selected as the primary outcome because it captures the comprehensive impact of MS on the participant's life and is the most representative measure of the study's primary aim. Also assessed at T0 (2 months before T1) to characterise within-subject stability during the no-intervention control period. Sample size (n=45) was not determined on MSIS-29, but conservatively on MFIS, the only pilot-study outcome non-significant at n=20 (MCID 4, SD 8.6, α=0.05, 1-β=0.8); MSIS-29 was significant in the pilot at n=20.

Time frame
Change from baseline (T1, immediately before intervention start) to T2 (2-month intensive intervention phase)

Secondary outcomes

1

Change in dynamic balance and stepping (Four Square Step Test, FSST)

Time (in seconds) required to step over four canes arranged in a square pattern in clockwise and counter-clockwise direction. Higher times indicate worse dynamic balance. Also assessed at T0 to characterise within-subject stability.

Time frame
Change from baseline (T1) to T2 (2 months of intensive intervention)
2

Change in walking endurance (Two-Minute Walk Test, 2MWT)

Distance (in meters) walked at a self-selected fast pace during 2 minutes. Higher distance indicates better walking capacity and endurance. Also assessed at T0.

Time frame
Change from baseline (T1) to T2 (2 months of intensive intervention)
3

Change in upper limb fine motor function (Nine Hole Peg Test, NHPT)

Time (in seconds) required to insert and remove 9 pegs from a board, performed separately with the dominant and non-dominant hand. Higher times indicate worse fine motor function. Also assessed at T0.

Time frame
Change from baseline (T1) to T2 (2 months of intensive intervention)
4

Change in upper limb tremor dominant frequency (inertial sensors)

Frequency (in Hz) for which the smoothed power spectral density is maximal (fmax), derived from the frequency characteristics of upper limb tremor measured using inertial sensors (a 3-axis accelerometer and a 3-axis gyroscope). A ring-shaped sensor is placed on the index finger of the upper limb in a defined posture; measured separately for each limb with the eyes open and closed. Also assessed at T0.

Time frame
Change from baseline (T1) to T2 (2 months of intensive intervention)

Other outcomes

1

Change in functioning, disability, and health profile (ICF Brief Core Set for Multiple Sclerosis)

Functioning, disability, and contextual factors assessed using the WHO International Classification of Functioning, Disability and Health (ICF) Brief Core Set for Multiple Sclerosis (Czech translation provided by ÚZIS), supplemented by additional categories focused on fine motor skills and upper limb control. Each category is rated using ICF qualifiers (0-4 for impairment severity; 0-4 / 8 / 9 for activities and participation). Assessment is conducted by an independent assessor through a structured interview, drawing on anamnestic data, clinical tests, questionnaires, and input from other specialists.

Time frame
Baseline (T0, 2 months before intervention start) and post-intensive phase (T2, 2 months of intensive intervention) - spanning 4 months total
2

Participant-reported satisfaction and acceptability of the programme

A brief structured questionnaire administered at the end of the 3-month programme. Items assess the participant's perceived benefit of intensive physiotherapy, comparison with prior spa-based rehabilitation, awareness of new self-management strategies, affordability of comparable therapy intensity without grant subsidy, and perceived importance of comprehensive care for people with MS. Responses are collected on item-specific Likert-type scales supplemented by an open-ended qualitative item. No single summary score is derived; items are analysed individually.

Time frame
End of 3-month programme

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charles University, Czech Republic

Lead sponsor

Institute for Clinical and Experimental Medicine

Collaborator

Faculty Hospital Kralovske Vinohrady

Collaborator

Czech Ministry of Education

Collaborator

This trial is not recruiting at the moment. You can still explore other options: