Идёт набор NCT07058896

Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Severe Gait Impairment: A Feasibility Study

Без фазы С лечением Multiple Sclerosis

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: High intensity task oriented circuit training + Telerehabilitation.
Кому может быть актуально: Состояния в реестре: Multiple Sclerosis. Базовые параметры: 18 лет — 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: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Severe Gait Impairment Via High Intensity Task Oriented Circuit Training: A Feasibility Study

Обзор

Multiple sclerosis (MS) is a progressive neurological disorder that often leads to severe gait impairment, limiting mobility and reducing the patient's quality of life. Motor rehabilitation has shown positive effects in people with MS (PwMS), but its efficacy tends to decrease as disability severity increases. High-intensity, task-oriented circuit training based on the principles of motor learning has been proposed as a potential strategy to improve motor function in severely impaired individuals. This approach combines the benefits of high-intensity training to the motor learning principles to enhance motor skills improvement and retention. The main questions it aims to answer are: * Can high-intensity, task oriented training in PwMS with severe gait impairment be feasible, safe and effective in enhancing motor function? * Can telerehabilitation maintain the benefits in gait and balance gained via circuit training for a six month period? Participants will: * Complete 12 session ( three hour each, three times a week) of high-intensity task oriented circuit training administered in a hospital setting. The training will target key motor skills such as walking, stepping, sit to stand, wheelchair, standing and bed mobillity. * Engage in 3 months of asynchronous telerehabilitation (without physiotherapist supervision), including monthly televisits.

Вмешательства

Поведенческое High intensity task oriented circuit training + Telerehabilitation
Participants will receive 12 sessions of high-intensity, task-oriented circuit training, three times a week for four weeks. Each session will last 180 minutes, with 108 minutes of active training. Each session will include three rounds, each lasting 51 minutes. During each round, participants will rotate between stations working for six minutes at each station, followed by three minutes of rest. The stations will focus on key motor skills, including sit-to-stand transitions, walking, standing, b

Первичные конечные точки

Change in Static Balance [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]

Вторичные конечные точки (12)

Change in Walking capacity [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Change in Walking speed [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Change in mobility, balance, walking ability, and fall risk [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Change in quantitative mobility and leg function performance [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Change in auditory information processing speed and flexibility [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Changes in functional lower extremity strength [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Change in cardiovascular fitness [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Change in Subjective Trait Fatigue [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Change in impacts of multiple sclerosis in people' lifes [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Change in balance confidence [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Change in functional performance of the upper extremity [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]
Change in self perceived manual ability [Срок оценки: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)]

Критерии участия

Критерии включения

Diagnosis of primary or secondary progressive multiple sclerosis according to the McDonald criteria.
Mini-Mental State Examination (MMSE) score > 24.
Expanded Disability Status Scale (EDSS) score ≥ 6.5.