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Completed

NCT Number: NCT07746856

Effect of Transcranial Direct Current Stimulation on Hand Recovery and Quality of Life in Hemiparetic Cerebral Palsied Children

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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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Out-patient Clinic, Faculty of Physical Therapy, October 6 University

Giza, Giza Governorate, 123, Egypt

About this study

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).

**Assessments:**

  • Height and weight scale - for body mass index (BMI) calculation
  • Modified Ashworth Scale (MAS) - for spasticity assessment
  • Digital hand held dynamometer (Jamar) - for grip strength measurement
  • Jebsen Taylor Hand Function Test (JTHFT) - for fine and gross motor hand function
  • Pediatric Quality of Life Inventory 4.0 (PedsQL) - for health-related quality of life

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.

  • Study Duration:** 1 month of treatment (12 sessions)
  • Follow-up:** No follow-up period beyond the 1-month treatment
  • Statistical Analysis:** Data will be analyzed using appropriate statistical methods to compare pre- and post-treatment outcomes within and between groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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.

Functional task training

Other

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.

Primary outcomes

  1. Change in Grip Strength of the Affected Hand

    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.

  2. Change in Hand Function - Jebsen-Taylor Hand Function Test

    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.

Secondary outcomes

  1. Change in Upper Limb Spasticity - Modified Ashworth Scale

    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.

  2. Change in Quality of Life - Physical Functioning

    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).

  3. Change in Quality of Life - Emotional, Social, and School Functioning

    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).

  4. Change in Quality of Life - Total Score

    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).

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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