Out-patient Clinic, Faculty of Physical Therapy, October 6 University
Giza, Giza Governorate, 123, Egypt
NCT Number: NCT07746856
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.
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Notify Me7 year–12 year
All sexes
Interventional
Not applicable
Giza, Giza Governorate, 123, Egypt
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.
**Assessments:**
The JTHFT consists of seven subsets: writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large lightweight and heavy objects. The test has good to excellent test-retest reliability and is easy to administer in clinical settings using readily available materials.
The PedsQL 4.0 Generic Core Scales consist of 23 items applicable for healthy school and community populations, as well as pediatric populations with acute and chronic health conditions. It has demonstrated reliability and validity in both healthy and patient populations.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 4 weeks post-treatment
Modified Ashworth Scale (MAS) - 6-point scale measuring muscle spasticity (0=no increase in muscle tone, 1=barely discernible increase, 1+=slight increase, 2=moderate increase, 3=profound increase, 4=complete rigidity). Lower values indicate reduced spasticity.
Time frame: Baseline and 4 weeks post-treatment
Pediatric Quality of Life Inventory 4.0 (PedsQL) Generic Core Scales - Physical Functioning domain. 8 items measuring physical health-related quality of life in children. Higher scores indicate better quality of life (0-100 scale).
Time frame: Baseline and 4 weeks post-treatment
Pediatric Quality of Life Inventory 4.0 (PedsQL) Generic Core Scales - Emotional (5 items), Social (5 items), and School (5 items) functioning domains. Higher scores indicate better quality of life (0-100 scale).
Time frame: Baseline and 4 weeks post-treatment
Pediatric Quality of Life Inventory 4.0 (PedsQL) Generic Core Scales - Total score (23 items combined). Higher scores indicate better quality of life (0-100 scale).
October 6 University
Other
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
Acronym: tDCS-HAND-CP
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