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

NCT07746856 | Completed

• 1 other identifier: O6U.PT.REC/024/002014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

Hemiparetic Cerebral Palsy; Transcranial Direct Current Stimulation; Hand Function; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Change in Grip Strength of the Affected Hand

  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.

  Baseline and 4 weeks post-treatment

• Change in Hand Function - Jebsen-Taylor Hand Function Test

  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.

  Baseline and 4 weeks post-treatment

Secondary Outcomes (4)

• 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

Study Arms (2)

tDCS Combined with Functional Task Training

EXPERIMENTAL

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.

Device: Transcranial Direct Current Stimulation; Other: Functional Task Training

Functional Task Training Only

ACTIVE COMPARATOR

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.

Other: Functional Task Training

Interventions

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.

tDCS Combined with Functional Task Training

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.

Functional Task Training Only; tDCS Combined with Functional Task Training

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

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

Giza, Giza Governorate, 123, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are randomly assigned to one of two parallel groups: tDCS + functional task training, or functional task training alone.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)