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Набор скоро начнётся NCT07248657

Comprehensive Therapeutic Program For People With Multiple Sclerosis

Без фазы С лечением Multiple Sclerosis Neurorehabilitation Rehabilitation Rehabilitation Exercise

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Outpatient physiotherapy, group psychotherapy.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Neurorehabilitation, Rehabilitation, Rehabilitation Exercise. Базовые параметры: до 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура Outpatient physiotherapy
    Physiotherapy sessions will be individually tailored according to each participant's goals. Soft tissue and joint techniques will be used as needed to prepare the body for optimal posture activation in sitting, standing, walking, and other movements. Therapists will use reflex, mobilization, and soft-tissue techniques. The Motor Program Activating Therapy method will be the primary approach, complemented by Dynamic Muscular Stabilization and movement self-awareness techniques.
  • Процедура group psychotherapy
    In addition, all participants will attend three 90-minute group psychotherapy sessions led by a psychologist. These sessions will support mental well-being, stress management, and motivation throughout the physiotherapy process. Participants will learn practical coping strategies for emotions, pain, and psychological strain. Relaxation techniques will be demonstrated and practiced, and basic nutritional recommendations will be provided in written or online form.

Первичные конечные точки

  • The Nine Hole Peg test (NHPT) [Срок оценки: Baseline and 4 months]
  • The Four Square Step Test (FSST) [Срок оценки: baseline and endpoint at 4 months]
  • The 2-Minute Walking Test (2MWT) [Срок оценки: baseline and endpoint at 4 months]
  • The Symbol Digit Modalities Test (SDMT) [Срок оценки: baseline and endpoint at 4 months]
Вторичные конечные точки (5)
  • Multiple Sclerosis Impact Scale (MSIS-29) [Срок оценки: baseline and end-point at 4 months]
  • Modified Fatigue Impact Scale (MFIS) [Срок оценки: baseline and end-point at 4 months]
  • Activities-Specific Balance Confidence Scale (ABC scale) [Срок оценки: baseline and end-point at 4 months]
  • International Classification of Functioning, Disability and Health (ICF) assessment [Срок оценки: baseline and 4 months]
  • tremor assessment [Срок оценки: baseline and 4 months]

Критерии участия

Критерии включения

  • Confirmed clinical diagnosis of MS
  • Age ≤ 75 years
  • Predominantly motor impairment
  • EDSS 2-8
  • Ability and motivation to attend outpatient physiotherapy regularly

Критерии исключения

  • Contraindications such as severe orthopedic or cardiovascular dysfunction, or presence of another neurological disorder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Чехия · 1 центр
  • Assossiation for Body in Balance — Prague

Идентификаторы

NCT: NCT07248657 · UK3LF/57 1290 12025-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗