Effect of Transcranial Direct Current Stimulation on Risk of Falling in Cerebral Palsy Spastic Hemiplegic Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial direct current stimulation, Exercise.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy (CP). Basic parameters: 8 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Transcranial direct current stimulation
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. - Other Exercise
selected traditional physical therapy program for improve balance and decrease risk of falling
Primary outcome measures
- The Fall Risk test [Time frame: From enrollment to the end of treatment at 8 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Giza
Identifiers
NCT: NCT06730763 · P.T.REC.012/005208