- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07629011
Effects of Mental Imagery Training Combined With Task Oriented Training by EMG-Driven Soft Robotic Hand Stroke in Stroke
Обзор исследования
Статус
Условия
Подробное описание
The World Health Organization (WHO) defines stroke as a condition marked by the sudden onset of clinical symptoms reflecting a focal or global disturbance in brain function, lasting more than 24 hours or leading to death, with no apparent cause other than a vascular origin. WHO estimates that approximately 15 million people worldwide experience a stroke each year. It continues term disability .Stroke remains a widespread concern in developing nations, but it continues to be largely overlooked. One of the most affected areas following stroke is the impairment of motor skill.
Motor deficits, especially hemiparesis, are frequently seen in stroke survivors and greatly hinder their ability to carry out daily activities, which in turn negatively influences their overall quality of life. Upper limb motor deficits are frequently seen in stroke survivors, with nearly 78% affected. Approximately 50% of them struggle particularly with hand function needed for daily living activities. Compensatory movements are frequently seen during upper extremity tasks, often involving proximal joints compensating for limited distal joint function. Most notable improvements in upper extremity motor function usually take place within the first six months after stroke onset. However, around 65% of stroke survivors continue to experience difficulty using their affected hand during the chronic stage. As a result, restoring upper extremity function especially hand function is crucial for chronic stroke survivors to achieve independence in daily activities.
Previous research has shown that task-oriented training can greatly improve upper extremity motor function, even in individuals with chronic stroke. The task- oriented approach is a functional activity-based method that emphasizes practicing specific tasks repeatedly to improve performance. The task-oriented approach incorporates such functional tasks, making it a practical intervention for patients. This treatment focuses on enhancing motor function by encouraging active use of the affected upper limb because patients use the unaffected side more during arm action, it is necessary to apply therapy to the affected arm.
Another technique used with stroke patients is Mental imagery(MI) /Mental Practice(MP) technique does not require great economic investments and can be performed anywhere, because no special equipment is needed. It is safe, given that the technique can be repeated many times without great physical effort. MI is a technique in which individuals imagine themselves performing physical tasks without any actual movement. Theory suggests that Mental rehearsal of a task activates the similar regions of the brain as activated by physical performance of the same task. Recent research indicates that when MI is combined with physical practice, it can significantly improve the recovery of motor functions. In MI, reactivation occurs when a movement is mentally simulated rather than physically executed, reflecting a voluntary effort. This allows individuals to develop and refine motor skills without actual movement.
Recently, wearable robotic hands have attracted considerable interest as rehabilitation tools in hospitals and therapy centers. These robotic devices help stroke patients perform repetitive hand functions such as opening and grasping. Research has demonstrated that rehabilitation using wearable robotic hands or gloves, which are activated by surface electromyography signals, combining with TOT can improve motor performance and reduce abnormal muscle tone patterns.
This study proposes integrating MI with TOT using soft robotic hand to potentially enhance motor learning and functional recovery by simultaneously engaging both cognitive and sensorimotor pathways. The combination could provide a synergistic effect, maximizing cortical activation and functional gains in stroke survivors with upper limb deficits. By investigating this approach, the study aims to contribute to more effective rehabilitation protocols for improving UL function post-stroke. This combination may lead to faster recovery and better motor performance without extra financial burden. This information can help rehabilitation professionals assess upper limb motor recovery, monitor progress, and develop targeted interventions.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Arshad Nawaz Malik, PhD Rehab
- Номер телефона: 03334503754
- Электронная почта: arshad.nawaz@riphah.edu.pk
Места учебы
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Punjab Province
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Rawalpindi, Punjab Province, Пакистан, 44000
- Рекрутинг
- Railway General Hospital
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Контакт:
- Arshad Nawaz Malik, PhD Rehab
- Номер телефона: 03334503754
- Электронная почта: arshad.nawaz@riphah.edu.pk
-
Главный следователь:
- Ayesha Umer, MS-NMPT*
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Participants clinically diagnosed with stroke in chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after stroke.
- 18-70 years of age.
- Sufficient cognition to follow simple instructions and understand the content and purpose of study (MMSE score 28)
- Able to sit up for at least 45 minutes.
- Detectable residual signals from the affected side's Flexor digitorum (FD) and Extensor Digitorum (ED) muscles.
- Modified Ashworth Scale (MAS) score of finger extensor less than or to 3
- Ability to provide informed consent
Exclusion Criteria:
- Patients with severe dysphasia with inadequate communication.
- Any additional medical or psychological condition affecting their ability to comply with the study protocol.
- History of other neurological disease or psychiatric disorders, including alcoholism and substance abuse
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Mental imagery training with Robotic hand training Group
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Participants will receive combined training of robotic hand-assisted task practice and mental imagery training over 7 weeks, 3 sessions per week, totaling 20 sessions. Each session (~60 minutes) conducted in a quiet room with the patient seated upright (hips, knees, ankles at 90°, forearms on table). Training involves real-life object handling tasks using three grip types:
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Активный компаратор: Robotic hand training
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Each session included a 5-minute warm-up, followed by three 15-minute EMG-driven, robot-assisted task blocks and two 5-minute breaks. Robotic Hand Tasks include: Real-life object handling using three grip types:
Muscle Monitoring: EMG signals recorded from flexor digitorum, extensor digitorum, biceps brachii, and triceps brachii. Maximum Voluntary Contraction assessed before each session; EMG activation threshold set at 3×SD above baseline. Training Activities will include: Grasping, lifting, holding, transporting, and releasing objects with robotic assistance and verbal guidance. Each 15-minute block included ~30-40 repetitions per task. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Fugl-Meyer Assessment Upper Extremity (FMA-UE).
Временное ограничение: 6 weeks
|
Evaluate sensorimotor impairment after stroke, especially in the upper limb. 3 Sections, (A) UPPER EXTREMITY
(B) Wrist Stability at 15 dorsiflexion (DF) (Elbow at 90)Repeated (DF) (Elbow at 90) Stability at 15 dorsiflexion (DF) (Elbow at 0) Circumduction (C)Hand Mass Flexion ,Mass Extension GRASP Finger mass flexion /Finger mass extension Thumb adduction ,Opposition, Cylindrical grip ,Spherical grip Normal = Score 0-66 A UE /36 B Wrist /10 C Hand /14 |
6 weeks
|
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Action research arm test (ARAT)
Временное ограничение: 6 weeks
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The ARAT is an observer-rated, performance-based assessment designed to measure upper extremity function and dexterity, especially after stroke or other cortical injuries. 4 Subscale
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6 weeks
|
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Box and block Test (BBT)
Временное ограничение: 6 weeks
|
Measures gross manual dexterity and speed Equipment: Wooden box (≈ 53.7 × 25.4 × 8.5 cm) with a partition, plus 150-152 blocks (≈ 2.5 cm cubes) Primary score: Number of blocks successfully transferred in 60 seconds (per hand).Only blocks completely transferred count; dropped blocks are excluded
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6 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Modified ashworth scale (MAS)
Временное ограничение: 6 weeks
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Measure muscle spasticity by assessing resistance during passive soft-tissue stretching. 0-4 Point scale Used to measure spasticity of finger, wrist, elbow Scoring 0,1,1+,2,3,4 |
6 weeks
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Ayesha Umer, MS-NMPT*, Riphah International Unversity
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 02261/ Ayesha Umer
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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