Effects of Multimodal Neuro Rehabilitation on Cortical Activity and Muscle Syenergy in Spastic Cerebral Palsy
4 мая 2026 г. обновлено: Riphah International University
- To determine the effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on cortical activity and muscle synergy.
- To determine the retention effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on cortical activity and muscle synergy, one-month follow-up across the five groups.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
- Устройство: Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training
- Устройство: Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training
- Устройство: Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
- Устройство: Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
- Другой: Conventional Physiotherapy
Подробное описание
- To determine the effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on
- gross motor function, gait, balance, mobility, dexterity, and spasticity.
- executive functions
- self-esteem.
Тип исследования
Интервенционный
Регистрация (Оцененный)
150
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Riafat Mehmood, PhD*
- Номер телефона: 0333551063
- Электронная почта: riafat.mehmood@riphah.edu.pk
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Children aged 6-18 years.
- Neurologist-confirmed spastic cerebral palsy.
- GMFCS Levels I-III (mild to moderate motor impairment).
- Ability to understand and follow simple instructions.
- Medically stable (no planned major surgery; no recent adjustment of medications affecting cortical excitability).
- Parental/guardian written informed consent and child assent.
Exclusion Criteria:
- Active uncontrolled epilepsy or history of seizure in the last year.
- Metal implants in the head or implanted medical/electrical devices (e.g., cochlear implants, ventriculoperitoneal shunts, pacemakers).
- Significant visual or auditory impairments that would interfere with task performance.
- Severe behavioral or cognitive difficulties that would prevent safe application of tDCS or training tasks.
- Currently taking medications known to significantly alter cortical excitability (e.g., benzodiazepines, antiepileptics) if dosage is unstable.
- Participation in other experimental neurorehabilitation or brain stimulation interventions within the last 6 months.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Group A: Active Anodal Transcranial direct current stimulation + Task-Oriented Training
Participants receive active anodal transcranial direct current stimulation (tDCS) applied concurrently with task-oriented training.
|
Active anodal transcranial direct current stimulation is delivered using a certified tDCS device at a low, safe intensity according to pediatric guidelines. Stimulation is applied to the scalp for approximately 20 minutes per session and is delivered concurrently with task-oriented training. Task-oriented activities individualized to motor deficits, emphasizing:
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Фальшивый компаратор: Sham Transcranial direct current stimulation + Task-Oriented Training
Participants receive sham (inactive) transcranial direct current stimulation combined with task-oriented training.
|
Sham stimulation will mimic active tDCS for the first 30 seconds (ramp up/down) and then deliver no current for the remainder of the session, ensuring blinding.
TOT protocol is identical to Group 1.
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Экспериментальный: Active Anodal Transcranial direct current stimulation + Virtual Reality Therapy
Participants receive active anodal transcranial direct current stimulation (tDCS) combined with virtual reality based rehabilitation.
|
Active anodal transcranial direct current stimulation is delivered using a certified tDCS device at a low, safe intensity according to pediatric guidelines. Stimulation is applied to the scalp for approximately 20 minutes per session and is delivered concurrently with Virtual Reality. System: Pediatric upper-limb and balance VR rehabilitation system Activities: Interactive tasks including
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Фальшивый компаратор: Sham Transcranial direct current stimulation + Virtual Reality Therapy
Participants receive sham (inactive) transcranial direct current stimulation combined with virtual reality based rehabilitation.
|
Sham stimulation will mimic active tDCS for the first 30 seconds (ramp up/down) and then deliver no current for the remainder of the session, ensuring blinding.
VR protocol identical to Group 3
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Активный компаратор: Conventional Physiotherapy
Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Cortical Activity
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
|
Quantitative electroencephalography (EEG) parameters to assess changes in brain activity specifically cortical activity.
EEG data will be recorded using a 14-channel system with electrodes placed according to the international 10-20 system, ensuring adequate spatial coverage of relevant cortical regions.
Resting-state EEG will be obtained under eyes-open and eyes-closed conditions (5 minutes each) to evaluate baseline neural activity.
At the event-related potentials (ERPs) cortical activity will be recorded during cognitive tasks such as oddball or Go/No-Go paradigms.
Primary outcomes will include changes in power spectral density across standard frequency bands and alterations in ERP components (P3, N2, P2) in terms of amplitude and latency.
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Change in Muscle Synergy Patterns
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
|
The outcome measures for this clinical trial will include quantitative electromyography (EMG) parameters and muscle synergy analysis to evaluate neuromuscular function.
Surface EMG signals will be recorded from key upper and lower limb muscles, including tibialis anterior, gastrocnemius medialis, soleus, rectus femoris, vastus lateralis, biceps femoris, semitendinosus, gluteus medius, flexor carpi radialis, extensor carpi radialis, biceps brachii, triceps brachii, deltoid, and first dorsal interosseous, at a sampling rate of ≥1000-2000 Hz following SENIAM guidelines for electrode placement.
Primary outcomes will include normalized EMG amplitude and temporal activation patterns during functional tasks, processed band-pass filtering (20-450 Hz), rectification, and envelope smoothing.
Muscle activity will be normalized using the maximum voluntary contraction (MVC) or peak-amplitude methods.
Secondary outcomes will include muscle synergy characteristics derived using a non-negative matrix
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Measure Gross Motor Function children.
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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GMFM-66 focusing on functional movements such as lying, sitting, standing, and walking.
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Measures balance in children.
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
|
Balance will be evaluated using the Pediatric Balance Scale (PBS; Children's Modified Berg, 14 items scored 0-4).
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Assesses walking speed in children
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Walking ability will be assessed using the 10-Meter Walk Test (10MWT) to calculate gait speed (m/s)
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Assesses mobility and balance in children
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
|
Timed Up and Go (TUG): Assesses mobility and balance.
(get out of a chair, walk three meters, turn, come back, and sit); time in seconds, average of two trials.
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Measures balance and reach ability in children
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Functional Reach Test (FRT): Measures balance and reach ability.
Two to three attempts are recorded in centimeters for the standard forward reach distance.
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Assesses manual dexterity in children
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Box & Block Test (BBT): Assesses manual dexterity.
The number of 1-inch cubes moved over the partition in 60 seconds, tested independently for each hand, and one practice trial was used to measure the standard BBT.
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Measures spasticity and muscle tone in children
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Modified Tardieu Scale (MTS): Measures spasticity and muscle tone.
Joint specific passive stretches are carried out at predetermined speeds (V1, V2, V3)
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Measures functional performance and disability in children.
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Pediatric Evaluation of Disability Inventory (PEDI / PEDI-CAT): Measures functional performance and disability.
record functional skills, caregiver support, and changes in self-care, mobility, and social function
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Assesses the child's self-esteem
Временное ограничение: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Rosenberg Self-Esteem Scale (Child Version): Assesses the child's self-esteem.
10-item, 4-point Likert scale; total score represents overall self-esteem
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Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Учебный стул: Waqar Ahmed Awan, PhD, Riphah International University
- Главный следователь: Riafat Mehmood, PhD*, Riphah International University
- Учебный стул: Qamar Mehmood, PhD, Riphah international univesty
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 июня 2026 г.
Первичное завершение (Оцененный)
18 ноября 2027 г.
Завершение исследования (Оцененный)
14 января 2028 г.
Даты регистрации исследования
Первый отправленный
17 февраля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
4 мая 2026 г.
Первый опубликованный (Действительный)
8 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
8 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
4 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Повреждение головного мозга, хроническое
- Церебральный паралич
- Терапия
- Поведенческие дисциплины и деятельность
- Электрическая стимуляционная терапия
- Судорожная терапия
- Психиатрическая соматическая терапия
- Электрошок
- Психологические методы
- Транскраниальная стимуляция постоянного тока
Другие идентификационные номера исследования
- PhD/011109
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .