Repetitive Transcranial Magnetic Stimulation Versus Botulinum Injection on Spasticity on Children With Diplegic Cerebral Palsy
- Conditions
- Spastic Diplegic Cerebral Palsy
- Interventions
- Device: Transcranial Magnetic StimulationOther: Rehabilitation Training Protocol
- Registration Number
- NCT06218316
- Lead Sponsor
- MTI University
- Brief Summary
This trial will enroll 75 children with spastic diplegic cerebral palsy both matched in age, sex, degree of disability and cognitive functions with the same exclusion criteria undergoing the same physical therapy. All enrolled children will undergo routine physical therapy program and will be divided into three groups (n = 25 per group) according treatment methods. Group A: children will be given local injections of botulinum toxin type ,Group B: children will be given repetitive transcranial magnetic stimulation on the affected side; Group C: children will be given local injections of botulinum toxin type A combined with repetitive transcranial magnetic stimulation , the three groups will take physical therapy (PT) of 45 minutes duration 4 days a week for 3 months .The grade of spasticity will be assessed by using Modified Ashworth scale and M/H ratio by using EMG. The grade of motor function will assessed by using Gross Motor Function Classification System (GMFCS).
- Detailed Description
This trial will enrol 75 children with spastic diaplegic cerebral palsy with both sex, degree of disability and cognitive functions with the same exclusion criteria and the same physical therapy program. All enrolled children will undergo routine physical therapy program and will be divided into three groups (n = 25 per group) according treatment methods. Group A: children will be given local injections of botulinum toxin type ,Group B: children will be given repetitive transcranial magnetic stimulation on the affected side; Group C: children will be given local injections of botulinum toxin type A combined with repetitive transcranial magnetic stimulation , the three groups will take physical therapy (PT) of 45 minutes duration 4 days a week for 3 months.
They will diagnosed based on history taking including perinatal, developmental, and family history, general and neurological examination. The included children with clinical diagnosis of moderate spastic diplegic cerebral palsy with a MAS (1, 1+, 2) and GMFCS (II, III, IV) will participated in this study. On the contrary, children with dyskinetic CP, mental retardation, previous ankle or knee surgery, uncontrolled epileptic seizure or contracture will excluded
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 75
- were diagnosed based on history taking including perinatal, developmental, and family history, general and neurological examination.
The included children with clinical diagnosis of moderate spastic dialogic cerebral palsy with a MAS (1, 1+, 2) and GMFCS (II, III, IV) were participated in this study
Children who's contraindicated to rTMS treatment have metal implants such as internal pacemakers and intracranial scaffolds, and/or a history of epilepsy.
- Children who's Contraindicated for BTX-A treatment: hypersensitivity and local infection at the injection site.
- Children which have received a local injection of BTX-A within 3 months.
- Children with dyskinetic CP,
- Mental retardation,
- previous, seizure or contracture were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botox combined with transcranial magnetic stimulation for spasticity Rehabilitation Training Protocol Botox combined with transcranial magnetic stimulation for spasticity in cerebral palsy children Botox for spasticity Rehabilitation Training Protocol Botox for spasticity in lower limbs in cerebral palsy children transcranial magnetic stimulation for spasticity Transcranial Magnetic Stimulation transcranial magnetic stimulation for spasticity in cerebral palsy children transcranial magnetic stimulation for spasticity Rehabilitation Training Protocol transcranial magnetic stimulation for spasticity in cerebral palsy children Botox combined with transcranial magnetic stimulation for spasticity Transcranial Magnetic Stimulation Botox combined with transcranial magnetic stimulation for spasticity in cerebral palsy children Botox for spasticity botulinum toxin A Botox for spasticity in lower limbs in cerebral palsy children Botox combined with transcranial magnetic stimulation for spasticity botulinum toxin A Botox combined with transcranial magnetic stimulation for spasticity in cerebral palsy children
- Primary Outcome Measures
Name Time Method modified aswthor scale 3 months Modified Ashworth Scale (MAS): The MAS measures the resistance and spasticity in the joint during passive movement. The resistance is scored from 0 to 5 (0 the least severe to 5 the most severe
- Secondary Outcome Measures
Name Time Method Gross Motor Function Classification System 3 months Gross Motor Function Classification System (GMFCS): The GMFCS provides a standardized system to classify the gross motor function of children with CP into five levels (level I the least severe to level V the most severe)
Trial Locations
- Locations (1)
faculty of pysical therapy, MTI university
🇪🇬Cairo, Egypt