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

2026年5月4日 更新者: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.

研究概览

详细说明

  • 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.

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的: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:

  • Functional reaching
  • Grasp-release tasks
  • Bilateral coordination
  • Balance and postural activities
  • Each session includes 10-15 task circuits, progressing from simple to complex tasks based on child performance.
假比较器: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.
实验性的: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

  • reaching,
  • stepping,
  • virtual object manipulation,
  • coordination games.
  • Session duration: 30 to 40 minutes Difficulty automatically progresses based on performance metrics (speed, accuracy, movement amplitude)
假比较器: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
有源比较器:Conventional Physiotherapy
Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.
  • 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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Cortical Activity
大体时间: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.
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Change in Muscle Synergy Patterns
大体时间: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
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measure Gross Motor Function children.
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
GMFM-66 focusing on functional movements such as lying, sitting, standing, and walking.
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measures balance in children.
大体时间: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).
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Assesses walking speed in children
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Walking ability will be assessed using the 10-Meter Walk Test (10MWT) to calculate gait speed (m/s)
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Assesses mobility and balance in children
大体时间: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.
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measures balance and reach ability in children
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Functional Reach Test (FRT): Measures balance and reach ability. Two to three attempts are recorded in centimeters for the standard forward reach distance.
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Assesses manual dexterity in children
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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.
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measures spasticity and muscle tone in children
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Modified Tardieu Scale (MTS): Measures spasticity and muscle tone. Joint specific passive stretches are carried out at predetermined speeds (V1, V2, V3)
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measures functional performance and disability in children.
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Assesses the child's self-esteem
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Rosenberg Self-Esteem Scale (Child Version): Assesses the child's self-esteem. 10-item, 4-point Likert scale; total score represents overall self-esteem
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Waqar Ahmed Awan, PhD、Riphah International University
  • 首席研究员:Riafat Mehmood, PhD*、Riphah International University
  • 学习椅:Qamar Mehmood, PhD、Riphah international univesty

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年11月18日

研究完成 (估计的)

2028年1月14日

研究注册日期

首次提交

2026年2月17日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月8日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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