Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation in Patients with Parkinson's Disease
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: Action Observation Training, Action Observation and Motor Imagery, Exercise.
- Кому может быть актуально
- Состояния в реестре: Parkinson Disease. Базовые параметры: Без ограничений · 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
Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation on Mobility, Posture and Brain Plasticity in Patients with Parkinson's Disease
Обзор
The goal of this clinical trial is to investigate the efficacy on motor and postural tasks of Action Observation Training (AOT) and Action Observation combined with Motor Imagery (AOMI) delivered by telerehabilitation in patients with Parkinson Disease. * The primary endpoint will be mobility measured with the Timed Up and Go (TUG) test (differences before and after telerehabilitation treatment period). * In addition, clinical and functional measures, instrumental analysis of gait and posture, and Magnetic Resonance Imaging (MRI) correlates will be assessed. Participants will be asked to undergo 24 telerehabilitation sessions, cadenced 3 per week, over an 8-week period. In the two experimental groups (AOT and AOMI), each telerehabilitation session will encompass 4 motor tasks, each containing the observation of a video clip immediately followed by the patient's execution or imagination of the same exercises. Patients in the control group will be instructed to perform the same exercises after watching videos showing landscapes
Подробное описание
The project is a a single center randomised controlled trial and aims to investigate the efficacy of Action Observation Training (AOT) and Action Observation with Motor Imagery (AOMI) delivered via telerehabilitation for improving motor and postural functions in patients with Parkinson's Disease (PD). Additionally, the study seeks to explore the cortical plasticity induced by AOMI using neuroimaging techniques. The primary outcome measure will be the Timed Up and Go (TUG) test, evaluating changes in mobility before and after the 8-week telerehabilitation intervention. Secondary outcomes include clinical and functional assessments, gait and gait initiation analysis and posture analysis. For gait and gait initiation analysis and posture analysis a sex and age matched healthy subjects cohort will be included. It will be also assessed postural motor resonance in AOT group and control group during action observation at all time point and results compared to sex and age match healthy cohort. Finally last 15 recruited patients of AOMI and control group will undergo fMRI investigation.
The study will enroll 60 PD patients, each meeting specific criteria. Participants will be randomly assigned to one of three groups: 1) AOT, 2) AOMI, or 3) a control group. The intervention will consist of 24 telerehabilitation sessions over 8 weeks (3 sessions per week). Each AOT and AOMI session will include four motor tasks, where patients will watch 3-minute video clips, followed by either performing (AOT) or imagining (AOMI) the exercise for 1 minute. Each task will be repeated twice, resulting in a 32-minute session. Exercises will focus on gait and balance, commonly used in PD rehabilitation. The control group will perform similar exercises after watching videos of neutral content, such as landscapes.
Assessments will be conducted by blinded evaluators at three time points: baseline (T0), immediately after the intervention period (T8W), and three months post-intervention (T5M).
Вмешательства
- Другое Action Observation Training
Action Observation Training (AOT) consists of patients observing videos of specific movements, followed by practice of those movements - Другое Action Observation and Motor Imagery
Action Observation and Motor Imagery (AOMI) consists of patients observing videos of specific movements, followed by mental rehearsal of those movements - Другое Exercise
After watching a landscape video, patients will have to perform specific postural and balance exercises
Первичные конечные точки
- Timed Up and Go test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
Вторичные конечные точки (12)
- Timed Up and Go test [Срок оценки: From enrollment to the end of follow-up at 3 months after end of training]
- Timed Up and Go test [Срок оценки: From end of training to the end of follow-up at 3 months after end of training]
- Movement Disorders Society Unified PD Rating Scale [Срок оценки: From enrollment to the end of treatment at 8 weeks]
- Movement Disorders Society Unified PD Rating Scale [Срок оценки: From enrollment to the end follow-up (3 months after end of training)]
- Movement Disorders Society Unified PD Rating Scale [Срок оценки: From end of training to the end follow-up (3 months after end of training)]
- Functional Independence Measure (FIM) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
- Functional Independence Measure (FIM) [Срок оценки: From enrollment to the end follow-up (3 months after end of training)]
- Functional Independence Measure (FIM) [Срок оценки: From end of treatment to the end of follow-up (3 months after end of treatment)]
- Parkinson's disease Questionnaire - 39 items (PDQ-39) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
- Parkinson's disease Questionnaire - 39 items (PDQ-39) [Срок оценки: From enrollment to the end follow-up (3 months after end of treatment)]
- Parkinson's disease Questionnaire - 39 items (PDQ-39) [Срок оценки: From end of treatment to the end of follow-up (3 months after end of treatment)]
- Mini-BEST Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
Критерии участия
Критерии включения
- diagnosis of clinically definite PD according to the Movement Disorders Society criteria
- Hoehn and Yahr scale <4
- Montreal Cognitive Assessment, MoCA ≥ 26
- a stable medication regimen for at least 4 weeks.
Критерии исключения
- Systemic, psychiatric, or other neurological illnesses influencing motor or functional performance
- a history of substance abuse influencing cognition or compliance
- visual disturbances
- head tremor
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Италия · 1 центр
- Istituto Clinico Humanitas — Rozzano
Идентификаторы
NCT: NCT06814782 · CLF24/01 · PRIN: 2022FABKJ5_2