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Effect of Specialised Physiotherapy and Supportive Psychotherapy on Clinical Status, Neuroplasticity, and Quality of Life in People With Multiple Sclerosis: A Prospective Interventional Study With a Self-Controlled Design
Not yet recruitingNot a drug-phase studyRelapsing and progressiveNCT07666958

What it found

Still running

No result yet.

What was tested

Treatment tested

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

What it measured

Main measures

  • 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)

    MRI lesionsFatigueQuality of life (reported by participants)

Other measures (14)

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

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

    Walking and mobility

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

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

    Walking and mobility

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

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

    Arm and hand function

  • Change in upper limb tremor dominant frequency (inertial sensors)

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

    Arm and hand functionPhysical function

  • Change in upper limb tremor spectral power (inertial sensors)

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

    Arm and hand functionPhysical function

  • Change in cognitive processing speed (Symbol Digit Modalities Test, SDMT)

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

    Thinking and memory

  • Change in self-reported fatigue impact (Modified Fatigue Impact Scale, MFIS total score)

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

    Thinking and memoryFatigue

  • Change in balance self-efficacy (Activities-specific Balance Confidence Scale, ABC)

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

    Walking and mobility

  • Change in generic health-related quality of life (EQ-5D-5L)

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

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • PwMS-rated global impression of change in gait and balance (7-point scale)

    At T2 (2 months of intensive intervention)

    Walking and mobility

Who could take part

Relapsing and progressive · 18 to 65

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)

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jul 2026

    2. Main results due

      Feb 2028

    3. Finished

      Jun 2028

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