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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

Study 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

Primary outcome measure(s)

• Change in MS-specific health impact (Multiple Sclerosis Impact Scale, MSIS-29 total score) — Change from baseline (T1, immediately before intervention start) to T2 (2-month intensive intervention phase)
  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.

Trial sites (1)

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