Идёт набор NCT07058870

Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Mild to Moderate 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 →

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Официальное название

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

Обзор

The goal of this feasibility study is to test the safety and effectiveness of an high-intensity task oriented circuit training program, followed by three months of telerehabilitation in people with mild to moderate Multiple Sclerosis (MS). The main questions it aims to answer are: * Can high-intensity task oriented circuit training improve gait and balance functional capacity? * Can telerehabilitation mantain the benefits in gait and balance gained via circuit training for a six month period? Participants will: * Complete 10 session ( one 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, supine to stand transitions and general mobility. * Engage in 3 months of asynchronous telerehabilitation (without physiotherapist supervision)

Вмешательства

Поведенческое High Intensity Task Oriented Circuit Training + Telerehabilitation
Participants will receive 10 sessions of high-intensity, task-oriented circuit training, three times a week. Each session will last 60 minutes, with minutes of active training. Each session will include three rounds, each lasting 55 minutes. During each round, participants will rotate between stations working for four minutes at each station, followed by three minutes of rest. The stations will focus on key motor skills, including supine to stand transitions, walking speed and functional capacit

Первичные конечные точки

Change in 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 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 Dual task Cost [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)]
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 ability to modify balance while walking in the presence of external demands [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 dynamic balance during an activity requiring weight-shift and movement while in single-leg stance [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 ability to transition from a supine positon to a standing position. [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 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 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 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)]

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.