A Novel Robotic System for Motor-cognitive Exercise for 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: Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD).
- Кому может быть актуально
- Состояния в реестре: Parkinson Disease, Idiopathic. Базовые параметры: 50 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
- Израиль
- 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 →
Обзор
The objective of this study is to test a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD). This pilot experiment will involve the collection of both subjective user evaluation measures and objective motor and cognitive measures.
Подробное описание
Participants \& Protocol:
Recruitment: Advertising ads in movement disorders units in hospitals and medical centers in the south, as well as through the help of the Parkinson's Association.
The study will be conducted with 15 PD patients, aged 50-75, at the Adi Negev Clinic. Each patient will use the robotic system five times, with each session lasting 30 minutes. The intervention plan incorporates principles of effective rehabilitation practice, including repeated practice, goal-oriented practice, variable difficulty, rhythmic cueing, and social interaction. Before the research begins, participants will sign an informed consent form.
Baseline and Pre-Post Tests:
Assessments including the MoCA, demographic data, clinical data, Color Trails Test (CTT), motor UPDRS, Box \& Blocks Test, and Cognitive Reserve Index Questionnaire (CRIq) will be collected before the first session by an occupational or physical therapist. After the fifth session, post-intervention assessments will include motor UPDRS, Box \& Blocks Test, CTT, System Usability Scale (SUS), Intrinsic Motivation Inventory (IMI), and a satisfaction questionnaire.
Hypothesis:
It is hypothesized that motor and cognitive training using the robots will improve the patients' clinical symptoms, as evidenced by pre-post test results.
Novelty \& Impact:
This is the first socially assistive robotic platform developed specifically for people with PD. If successful, this platform could be incorporated into the clinical toolbox at Adi Negev and other centres. Additionally, this study will be the first to use the Cognitive Reserve Index Questionnaire (CRIq) in Hebrew for people with PD. The potential impact of this project is twofold: testing a new rehabilitation tool and a screening tool for PD patients.
Вмешательства
- Устройство Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD)
This is the first socially assistive robotic platform developed specifically for people with PD. If successful, this platform could be incorporated into the clinical toolbox at Adi Negev and other centres.
Первичные конечные точки
- level of engagement [Срок оценки: 2 Mon]
Вторичные конечные точки (5)
- improvement in UPDRS [Срок оценки: 4 Mon]
- improvement in fine motor coordination [Срок оценки: 4 Mon]
- improvement in CTT (Color Trail Test) [Срок оценки: 4 Mon]
- Testing the usability of use of the system [Срок оценки: 4 Mon]
- Measuring the motivation to use the system [Срок оценки: 4 Mon]
Критерии участия
Критерии включения
- Signing the informed consent form
- Men and women in ages 50-75
- Hebrew speakers
- Have Idiopathic Parkinson's disease
- Hoehn and Yahr 3 and below
- Moca test 23 and above
Критерии исключения
- Patients with Parkinson's plus syndromes
- PD patients who suffer from unrelated neurological symptoms.
- Orthopedic problems of the upper limb
- Recent surgery conducted on the upper limb
- Uncorrected vision problems
- Uncorrected severe hearing loss
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
- Организация здравоохранения
Центры проведения
Израиль · 1 центр
- Adi Negev — Ofakim
Идентификаторы
NCT: NCT06730074 · 0005-NGV-24