Cerebral PalsytDCS-HAND-CPNCT07746856
Effect of Transcranial Direct Current Stimulation on Hand Recovery and Quality of Life in Hemiparetic Cerebral Palsied Children
A study testing Transcranial Direct Current Stimulation and Functional Task Training in people with Cerebral Palsy, run by October 6 University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Transcranial Direct Current Stimulation and Functional Task Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Out-patient Clinic, Faculty of Physical Therapy, October 6 University
Giza, Giza Governorate, 123
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Cerebral Palsy
- Being tested
- Transcranial Direct Current Stimulation, Functional Task Training
- Keywords
- Hemiparetic Cerebral Palsy, Transcranial Direct Current Stimulation, Hand Function, Quality of Life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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 TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Functional Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 4 weeks post-treatment
Secondary outcomes (4)
Change in Upper Limb Spasticity - Modified Ashworth Scale
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.
Measured: Baseline and 4 weeks post-treatment
Change in Quality of Life - Physical Functioning
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).
Measured: Baseline and 4 weeks post-treatment
Change in Quality of Life - Emotional, Social, and School Functioning
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).
Measured: Baseline and 4 weeks post-treatment
Change in Quality of Life - Total Score
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).
Measured: Baseline and 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Oct 2025
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel groups: tDCS + functional task training, or functional task training alone.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Saber Hussain, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746856
- Sponsor's protocol ID
- O6U.PT.REC/024/002014
- Acronym
- tDCS-HAND-CP
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07746856
- Acronym / sponsor ID
- tDCS-HAND-CP / O6U.PT.REC/024/002014
- Conditions
- Cerebral Palsy
- Keywords
- Hemiparetic Cerebral Palsy, Transcranial Direct Current Stimulation, Hand Function, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups: tDCS + functional task training, or functional task training alone.
| Arm | Type | Receives |
|---|---|---|
| tDCS Combined with Functional Task Training | Experimental | Device: Transcranial Direct Current Stimulation, Other: Functional Task TrainingAnodal 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 Only | Active comparator | Other: Functional Task TrainingA 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAnodal 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 | tDCS Combined with Functional Task Training |
| Functional Task TrainingA 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 Only, tDCS Combined with Functional Task Training |
Primary outcome
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.
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.
4 secondary outcomes
Change in Upper Limb Spasticity - Modified Ashworth Scale
Time frame: Baseline and 4 weeks post-treatment
Change in Quality of Life - Physical Functioning
Time frame: Baseline and 4 weeks post-treatment
Change in Quality of Life - Emotional, Social, and School Functioning
Time frame: Baseline and 4 weeks post-treatment
Change in Quality of Life - Total Score
Time frame: Baseline and 4 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation and Functional Task Training in people with Cerebral Palsy, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Grip Strength of the Affected Hand (time frame: Baseline and 4 weeks post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.