Comprehensive Therapeutic Program For People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The Nine Hole Peg test (NHPT)
研究概览
简要总结
This study investigates the effectiveness of an intensive multidisciplinary rehabilitation program for people with multiple sclerosis (PwMS). The program integrates intensive outpatient physiotherapy, psychotherapeutic consultations, and nutritional counseling to enhance motor and cognitive functions, promote neuroplasticity, and improve overall well-being as well as physical performance in PwMS. Through clinical assessments and standardized questionnaires, the study aims to provide scientific evidence on the benefits of comprehensive, non-pharmacological therapy as a core element in MS treatment.
详细描述
Multiple sclerosis (MS) is a chronic neurological disease predominantly affecting young adults and often leads to significant limitations in both professional and social life. Current therapeutic approaches apart from pharmacotherapy, emphasize non-pharmacological interventions, rehabilitation, and holistic lifestyle modifications (Duan, 2023).
This study provides individuals with MS the opportunity to participate in an intensive 4-month single-arm therapeutic program that combines specialized outpatient physiotherapy, psychotherapy, and nutritional counseling. The physiotherapy component is based on a scientifically validated approach-Motor Program Activating Therapy-which directly targets motor control and central nervous system function (Řasová, 2015).The program was developed by two physiotherapists specializing in MS during their doctoral studies (Procházková, 2020; Prokopiusová, 2020), whose research focused on factors influencing disease progression and the efficacy of physiotherapeutic interventions. In this prospective study participants will undergo outpatient program aiming to enhance neuroplasticity, improve physical and psychological functions, physical performance and contribute to long-term health maintenance.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of MS
- •Age ≤ 75 years
- •Predominantly motor impairment
- •Ability and motivation to attend outpatient physiotherapy regularly
排除标准
- •Contraindications such as severe orthopedic or cardiovascular dysfunction, or presence of another neurological disorder
研究组 & 干预措施
COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS
This is a prospective single-arm study. Participants will undergo a four-month rehabilitation program consisting of physiotherapy sessions twice per week for the first two months (50 minutes each), once weekly during the third month, and once every two weeks in the fourth month. All participants will receive a combined outpatient intervention consisting of individually tailored physiotherapy and group psychotherapy.
Physiotherapy will focus on posture correction, movement control, and functional mobility using the Motor Program Activating Therapy method, complemented by Dynamic Muscular Stabilization, manual, and soft-tissue techniques. Additionally, participants will attend three 90-minute group psychotherapy sessions aimed at supporting mental well-being, stress management, and motivation during rehabilitation, including education on coping strategies, relaxation, and nutrition.
干预措施: Outpatient physiotherapy (Procedure)
COMPREHENSIVE THERAPEUTIC PROGRAM FOR PEOPLE WITH MULTIPLESCLEROSIS
This is a prospective single-arm study. Participants will undergo a four-month rehabilitation program consisting of physiotherapy sessions twice per week for the first two months (50 minutes each), once weekly during the third month, and once every two weeks in the fourth month. All participants will receive a combined outpatient intervention consisting of individually tailored physiotherapy and group psychotherapy.
Physiotherapy will focus on posture correction, movement control, and functional mobility using the Motor Program Activating Therapy method, complemented by Dynamic Muscular Stabilization, manual, and soft-tissue techniques. Additionally, participants will attend three 90-minute group psychotherapy sessions aimed at supporting mental well-being, stress management, and motivation during rehabilitation, including education on coping strategies, relaxation, and nutrition.
干预措施: group psychotherapy (Procedure)
结局指标
主要结局
The Nine Hole Peg test (NHPT)
时间窗: Baseline and 4 months
measures speed (in seconds) of this fine hand movement task
The Four Square Step Test (FSST)
时间窗: baseline and endpoint at 4 months
Time (in seconds) to reach clockwise and counterclockwise stepping task
The 2-Minute Walking Test (2MWT)
时间窗: baseline and endpoint at 4 months
The distance one is able walk in two minutes, including noting stops needed and mobility aids (e.g., crutches, canes, or walkers)
The Symbol Digit Modalities Test (SDMT)
时间窗: baseline and endpoint at 4 months
A brief neuropsychological test assessing attention, visual scanning, processing speed, and working memory. Participants match symbols to numbers according to a reference key within a limited time - 90 seconds - the final score is result
次要结局
- Multiple Sclerosis Impact Scale (MSIS-29)(baseline and end-point at 4 months)
- Modified Fatigue Impact Scale (MFIS)(baseline and end-point at 4 months)
- Activities-Specific Balance Confidence Scale (ABC scale)(baseline and end-point at 4 months)
- International Classification of Functioning, Disability and Health (ICF) assessment(baseline and 4 months)
- tremor assessment(baseline and 4 months)
研究者
Kamila Řasová
prof. PhDr. Kamila Rasova, Ph.D.
Charles University, Czech Republic