Effects of Multimodal Neuro Rehabilitation on Cortical Activity and Muscle Syenergy in Spastic Cerebral Palsy

Обзор

* 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.

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.

Вмешательства

• Устройство Active Anodal Transcranial Direct Current Stimulation (tDCS) + 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: * Functional reaching * Grasp-release tasks * Bilateral coordination * Balance and postural activities * Each session includes 10-15 t
• Устройство Sham Active Anodal Transcranial Direct Current Stimulation + 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.
• Устройство Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
  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 * reaching, * stepping, * virtual object manipulation, * coordination games. * Session duration: 30 to 40 m
• Устройство Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
  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
• Другое Conventional Physiotherapy
  * Stretching of spastic muscle groups * Strengthening exercises for weak muscle groups * Balance and gait training * Functional mobility practice * Session duration: 45 minutes. Delivered by a trained pediatric physiotherapist following standard clinical guidelines.

Первичные конечные точки

• Change in Cortical Activity [Срок оценки: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
• Change in Muscle Synergy Patterns [Срок оценки: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
• Measure Gross Motor Function children. [Срок оценки: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
• Measures balance in children. [Срок оценки: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
• Assesses walking speed in children [Срок оценки: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
• Assesses mobility and balance in children [Срок оценки: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
• Measures balance and reach ability in children [Срок оценки: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
• Assesses manual dexterity in children [Срок оценки: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
• Measures spasticity and muscle tone in children [Срок оценки: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
• Measures functional performance and disability in children. [Срок оценки: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07574996 · PhD/011109

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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