Effects of Multimodal Neuro Rehabilitation on Cortical Activity and Muscle Syenergy in Spastic Cerebral Palsy
- 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
地位
条件
干预/治疗
- 设备:Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training
- 设备:Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training
- 设备:Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
- 设备:Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
- 其他:Conventional Physiotherapy
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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Riafat Mehmood, PhD*
- 电话号码:0333551063
- 邮箱:riafat.mehmood@riphah.edu.pk
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
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
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 |
|---|---|
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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.
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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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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.
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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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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.
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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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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.
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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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有源比较器:Conventional Physiotherapy
Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.
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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 |
|---|---|---|
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Change in Cortical Activity
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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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
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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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.
大体时间: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.
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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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
大体时间: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
大体时间:Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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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
大体时间: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
大体时间: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
大体时间: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.
大体时间: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
大体时间: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
|
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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合作者和调查者
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
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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