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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Scientific Rationale
The management of multiple sclerosis (MS) increasingly emphasises non-pharmacological approaches, as available pharmacological treatments have limited effect on existing damage to motor and cognitive systems. Neuroplasticity - the brain's ability to adapt and restore its functions - represents a key mechanism of functional recovery that can be stimulated through targeted rehabilitation. Functional magnetic resonance imaging (fMRI) enables the assessment of these neuroplastic processes and helps identify the relationship between changes in brain connectivity and clinical improvement. Review articles confirm that targeted motor and cognitive rehabilitation in MS modifies clinical function and leads to measurable changes in brain activity and structural connectivity, indicating neuroplasticity activation.
Among rehabilitation approaches, facilitation-based physiotherapy holds particular promise for stimulating neuroplasticity, as it directly targets activation of the central nervous system. The efficacy of one such method (Motor Programme Activating Therapy) has been demonstrated through fMRI (reorganisation of brain activity and connectivity) and clinical tests. Comprehensive rehabilitation should also encompass psychological and behavioural support, as psychotherapy helps manage stress, supports treatment adherence, and positively influences quality of life.
Pilot Study and Rationale for the Present Project
The research team validated a comprehensive therapeutic programme in a pilot study involving 20 newly diagnosed individuals with MS (Hruskova et al., 2024, Front Neurol). The pilot showed significant reduction in fatigue and an increase in life satisfaction, with effects persisting for 12 months. However, these results are based on a smaller sample focused on early-stage disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究者
Kamila Řasová
prof.
Charles University, Czech Republic