Cerebral Palsy (CP)NCT06730763
Effect of Transcranial Direct Current Stimulation on Risk of Falling in Cerebral Palsy Spastic Hemiplegic Children
A study testing Transcranial direct current stimulation and Exercise in people with Cerebral Palsy (CP), run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study was to determine: If there is an effect of transcranial direct current stimulation in improvement the functional balance in CP spastic hemiplegic children. If there are any changes in risk of falling in CP spastic hemiplegic children or not. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Transcranial direct current stimulation and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range between 8-12 years old.
- Classified on levels II and III of the Gross Motor Function Classification System (GMFCS) (Palisiano et al.,1997).
- the ability to walk without the assistance of another individual for at least 12 months prior to the onset of the study, regardless of whether a gait-assistance device was needed (GMFCS level III) or not (GMFCS level II).
- (Pediatric Balance Scale, Timed Up and Go Test 'TUGT') and acceptance of the TDCS procedure.
- Ability to understand and follow simple instructions.
- Parent or guardian consent obtained
Who cannot join
- Orthopedic deformities, a history of surgery or neurolytic block in the previous 12 months,
- Diagnosis of epilepsy or having experienced convulsive crises (whether treated with medication or not) in at least the two years prior to the onset of the study, metal implants in the skull, or the use of hearing aids.
- Previous participation in a tDCS study within the past 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, Giza Governorate, 3753450
Islam Hassan Fayed, Doctorate, 00201097279742, islamfayed@outlook.com
About this study
The purpose of this study was to determine:
- If there is an effect of transcranial direct current stimulation in improvement the functional balance in CP spastic hemiplegic children.
- If there are any changes in risk of falling in CP spastic hemiplegic children or not.
Read the detailed description
With the decline of mobility comes a drastic increase in falling. However, people of all ages with cerebral palsy can fall easily due to imbalance issues and non-voluntary movements. Individuals with cerebral palsy (CP) can experience a variety of sensorimotor impairments that impact balance, making excessive tripping and falling among the most common concerns for ambulatory individuals with CP. Approximately 53-97% of ambulatory individuals fall at least once per year, causing injury, embarrassment, frustration, activity avoidance, and isolation. Although a study of over 1000 children found fall frequency was highest in gross motor function classification system (GMFCS) level II, research has not explored if this holds across the decades of adulthood.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Transcranial direct current stimulation, Exercise
- Keywords
- cerebral palsy, spastic hemiplegia, risk of falling
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Also called transcranial, TcDc
Transcranial direct current stimulation (TDCS) is a non-invasive, painless brain stimulation treatment that uses direct electrical currents to stimulate specific parts of the brain.
ExerciseOther
Also called traditional
selected traditional physical therapy program for improve balance and decrease risk of falling
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | will receive selected traditional physical therapy program for improve balance and decrease risk of falling only. Receives: Device: Transcranial direct current stimulation; Other: Exercise |
| Group 2 | Active comparator | will receive transcranial direct current stimulation plus selected traditional physical therapy program. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fall Risk test
The fall risk test allowed identification of potential fall candidates. Test results were compared to age dependent normative data. Scores higher than normative values suggested more fall risk index
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Dec 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ahmed Fathy Mahmoud Awd, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730763
- Sponsor's protocol ID
- P.T.REC.012/005208
- Status last verified
- Feb 2025
- First submitted
- 9 Dec 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct Current Stimulation on Risk of Falling in Cerebral Palsy Spastic Hemiplegic Children
- ClinicalTrials.gov ID
- NCT06730763
- Acronym / sponsor ID
- P.T.REC.012/005208
- Conditions
- Cerebral Palsy (CP)
- Keywords
- cerebral palsy, spastic hemiplegia, risk of falling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 12 Dec 2024 (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.
The purpose of this study was to determine:
- If there is an effect of transcranial direct current stimulation in improvement the functional balance in CP spastic hemiplegic children.
- If there are any changes in risk of falling in CP spastic hemiplegic children or not.
Detailed description
With the decline of mobility comes a drastic increase in falling. However, people of all ages with cerebral palsy can fall easily due to imbalance issues and non-voluntary movements. Individuals with cerebral palsy (CP) can experience a variety of sensorimotor impairments that impact balance, making excessive tripping and falling among the most common concerns for ambulatory individuals with CP. Approximately 53-97% of ambulatory individuals fall at least once per year, causing injury, embarrassment, frustration, activity avoidance, and isolation. Although a study of over 1000 children found fall frequency was highest in gross motor function classification system (GMFCS) level II, research has not explored if this holds across the decades of adulthood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Transcranial direct current stimulation, Other: Exercisewill receive selected traditional physical therapy program for improve balance and decrease risk of falling only. |
| Group 2 | Active comparator | Other: Exercisewill receive transcranial direct current stimulation plus selected traditional physical therapy program. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age range between 8-12 years old.
- Classified on levels II and III of the Gross Motor Function Classification System (GMFCS) (Palisiano et al.,1997).
- the ability to walk without the assistance of another individual for at least 12 months prior to the onset of the study, regardless of whether a gait-assistance device was needed (GMFCS level III) or not (GMFCS level II).
- (Pediatric Balance Scale, Timed Up and Go Test 'TUGT') and acceptance of the TDCS procedure.
- Ability to understand and follow simple instructions.
Key exclusion criteria (3 listed)
- Orthopedic deformities, a history of surgery or neurolytic block in the previous 12 months,
- Diagnosis of epilepsy or having experienced convulsive crises (whether treated with medication or not) in at least the two years prior to the onset of the study, metal implants in the skull, or the use of hearing aids.
- Previous participation in a tDCS study within the past 6 months.
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 stimulationAlso: transcranial, TcDcTranscranial direct current stimulation (TDCS) is a non-invasive, painless brain stimulation treatment that uses direct electrical currents to stimulate specific parts of the brain. | Device | Group 1 |
| ExerciseAlso: traditionalselected traditional physical therapy program for improve balance and decrease risk of falling | Other | Group 1, Group 2 |
Primary outcome
The Fall Risk test
Time frame: From enrollment to the end of treatment at 8 weeks
The fall risk test allowed identification of potential fall candidates. Test results were compared to age dependent normative data. Scores higher than normative values suggested more fall risk index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Exercise in people with Cerebral Palsy (CP), run by Cairo 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 3 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed fathy Awad, Master degree (00201061263992, ahmedawdpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fall Risk test (time frame: From enrollment to the end of treatment at 8 weeks). 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 11 Feb 2025.