Effect of Transcranial Direct Current Stimulation Combined With Physiotherapy on Hand Function and Quality of Life in Children With Hemiparetic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Grip Strength of the Affected Hand
研究概览
简要总结
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may help improve hand function in children with cerebral palsy. This study investigates whether tDCS combined with functional task training is more effective than functional task training alone for improving hand recovery and quality of life in children with hemiparetic cerebral palsy.
Sixty children aged 7 to 12 years with hemiparetic cerebral palsy will be randomly assigned to one of two groups. The experimental group will receive anodal tDCS at 2mA for 20 minutes, 3 times per week for 1 month, combined with 40 minutes of functional task training. The control group will receive functional task training alone for 60 minutes, 3 times per week for 1 month.
Hand function will be measured using the Jebsen Taylor Hand Function Test and grip strength using a hand held dynamometer. Spasticity will be assessed using the Modified Ashworth Scale, and quality of life will be measured using the Pediatric Quality of Life Inventory 4.0 (PedsQL). All assessments will be conducted before and after the 1-month treatment period.
The findings of this study may help determine whether adding tDCS to standard rehabilitation provides additional benefits for hand recovery and quality of life in children with hemiparetic cerebral palsy.
详细描述
Cerebral palsy (CP) refers to a group of diseases characterized by persistent central dyskinesia, postural development disorder, and activity limitation syndromes caused by non-progressive brain injury in the developing fetus or infant. It is often accompanied by sensory, cognitive, and attention disorders. Routine rehabilitation methods for children with CP include physical therapy, occupational therapy, and speech therapy. In recent years, non-invasive brain stimulation (NIBS) techniques have been used to regulate cortical excitability and plasticity.
Transcranial direct current stimulation (tDCS) is a NIBS technique that is easier and more convenient to perform than other methods. It does not require patients to remain stationary for a long time, making it suitable for children. tDCS can be combined with occupational or speech therapy, reducing overall treatment time and avoiding burnout due to long treatment sessions.
This study uses a controlled, blinded, parallel-group, pre- and post-study design. A single trained investigator will evaluate all patients and collect all data to eliminate inter-investigator error. Patients will be divided into two equal groups according to the treatment procedure.
Sixty hemiparetic cerebral palsy children (both sexes, aged 7 to 12 years) will be randomly assigned to the experimental or control group.
- Experimental Group:** Participants receive anodal transcranial direct current stimulation (a-tDCS) applied to the ipsilesional hemisphere at 2mA for 20 minutes, 3 times per week for 1 month (total 12 sessions), combined with 40 minutes of functional task training directed toward hand recovery.
- Control Group:** Participants receive functional task training directed toward hand recovery for 60 minutes, 3 times per week for 1 month (total 12 sessions).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
A single trained investigator will evaluate all patients and collect all data to eliminate inter-investigator error. The evaluating investigator is blinded to group allocation. Participants and care providers are not masked due to the nature of the tDCS intervention.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 7 to 12 years old
- •Diagnosis of unilateral spastic hemiparetic cerebral palsy
- •Both sexes (male and female)
- •Able to understand and follow simple instructions
- •Able to maintain a sitting position for at least 60 minutes
- •Stable medication regimen for at least 3 months prior to study entry
排除标准
- •Blindness, sickness, or language defects impairing patient cooperation
- •Epilepsy or abnormal electroencephalography (EEG)
- •Previous brain surgery
- •Skin irritation or dysfunction at electrode placement site
- •Metallic implants within the brain
- •Inability to consent or undergo tDCS therapy
- •Presence of cardiac abnormalities
- •Received botulinum toxin injections in the upper limb within the past 6 months
研究组 & 干预措施
tDCS Combined with Functional Task Training
Anodal tDCS applied to the primary motor cortex of the affected hemisphere at an intensity of 1.5 mA for 20 minutes per session, 5 sessions per week for 4 weeks (total of 20 sessions). Active electrode (anode) placed over the motor cortex of the affected hemisphere; reference electrode (cathode) placed over the contralateral supraorbital region.
干预措施: Transcranial Direct Current Stimulation (Device)
tDCS Combined with Functional Task Training
Anodal tDCS applied to the primary motor cortex of the affected hemisphere at an intensity of 1.5 mA for 20 minutes per session, 5 sessions per week for 4 weeks (total of 20 sessions). Active electrode (anode) placed over the motor cortex of the affected hemisphere; reference electrode (cathode) placed over the contralateral supraorbital region.
干预措施: Functional Task Training (Other)
Functional Task Training Only
A structured 45-minute physiotherapy program including warm-up and mobility exercises, progressive resistance strength training, fine motor training (e.g., peg placement, object manipulation), bimanual training, and task-oriented training (e.g., grasping, stacking, utensil use). Delivered 5 sessions per week for 4 weeks.
干预措施: Functional Task Training (Other)
结局指标
主要结局
Change in Grip Strength of the Affected Hand
时间窗: Baseline and 4 weeks post-treatment
Grip strength measured using a digital hand-held dynamometer (Jamar, Preston, USA). Participants squeezed the dynamometer as hard as possible for 3-5 seconds. Three trials were performed for each hand, and the highest value was recorded. Higher values indicate better hand strength.
Change in Hand Function - Jebsen-Taylor Hand Function Test
时间窗: Baseline and 4 weeks post-treatment
Jebsen-Taylor Hand Function Test (JTHFT) measuring time in seconds to complete 7 subtests: writing, simulated page-turning, lifting small objects, simulated feeding, stacking, lifting lightweight objects, and lifting heavy objects. Lower scores indicate better hand function.
次要结局
- Change in Upper Limb Spasticity - Modified Ashworth Scale(Baseline and 4 weeks post-treatment)
- Change in Quality of Life - Physical Functioning(Baseline and 4 weeks post-treatment)
- Change in Quality of Life - Emotional, Social, and School Functioning(Baseline and 4 weeks post-treatment)
- Change in Quality of Life - Total Score(Baseline and 4 weeks post-treatment)
研究者
Walid Saber Hussain
Assistant Professor
October 6 University