Repetitive Transcranial Magnetic Stimulation Versus Botulinum Injection on Spasticity on Children With Diplegic Cerebral Palsy

MTI University

Status: Completed

Conditions: Spastic Diplegic Cerebral Palsy

Treatments: Other: Rehabilitation Training Protocol; Device: Transcranial Magnetic Stimulation; Drug: botulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT06218316

P.T.REC/012/004846

Details and patient eligibility

About

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).

Full 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

Enrollment: 75 patients

Sex: All

Ages: 4 to 4 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Botox for spasticity

Experimental group

Description:

Botox for spasticity in lower limbs in cerebral palsy children

Treatment:

Drug: botulinum toxin A

Other: Rehabilitation Training Protocol

transcranial magnetic stimulation for spasticity

Experimental group

Description:

transcranial magnetic stimulation for spasticity in cerebral palsy children

Treatment:

Device: Transcranial Magnetic Stimulation

Other: Rehabilitation Training Protocol

Botox combined with transcranial magnetic stimulation for spasticity

Experimental group

Description:

Botox combined with transcranial magnetic stimulation for spasticity in cerebral palsy children

Treatment:

Drug: botulinum toxin A

Device: Transcranial Magnetic Stimulation

Other: Rehabilitation Training Protocol