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

NCT06218316 | Completed

• 1 other identifier: P.T.REC/012/004846
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Spastic Diplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• modified aswthor scale

  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

  3 months

Secondary Outcomes (1)

• Gross Motor Function Classification System

  3 months

Other Outcomes (1)

• Electromyography

  3 months

Study Arms (3)

Botox for spasticity

EXPERIMENTAL

Botox for spasticity in lower limbs in cerebral palsy children

Drug: botulinum toxin A; Other: Rehabilitation Training Protocol

transcranial magnetic stimulation for spasticity

EXPERIMENTAL

transcranial magnetic stimulation for spasticity in cerebral palsy children

Device: Transcranial Magnetic Stimulation; Other: Rehabilitation Training Protocol

Botox combined with transcranial magnetic stimulation for spasticity

EXPERIMENTAL

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

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

Interventions

botulinum toxin A DRUG

Botulinum Neurotoxin A (BoNT-A) Injections will administered directly into the bulk of the muscles, with two injection sites at each head of the gastrocnemius and two sites into the medial hamstring. one vial of BoNT-A in 2 mL of 0.9% sodium chloride solution. followed by a 3-month rehabilitation program. The entire intervention including rTMS, BoNT-A, and rehabilitation training program spanned a period of three months.

Botox combined with transcranial magnetic stimulation for spasticity; Botox for spasticity

Transcranial Magnetic Stimulation DEVICE

Repeated Transcranial Magnetic Stimulation (rTMS) Stimulation coil will strategically place on the primary motor cortex (M1), The patients received 1500 pulses per session, two sessions per week for 3 months, in a combination with 3-month rehabilitation program.

Botox combined with transcranial magnetic stimulation for spasticity; transcranial magnetic stimulation for spasticity

Rehabilitation Training Protocol OTHER

Rehabilitation Training Protocol: As part of the study protocol, all participating children underwent a comprehensive weekly routine rehabilitation training program. Training Schedule: sessions will conduct for duration of 45 minutes. Training occurred four days a week.

Botox combined with transcranial magnetic stimulation for spasticity; Botox for spasticity; transcranial magnetic stimulation for spasticity

Eligibility Criteria

• Age: 4 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

faculty of pysical therapy, MTI university

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatric physical therapy

Model Details: one-way analysis of variance (ANOVA)

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 23, 2024
• Study Start: October 15, 2023
• Primary Completion: January 20, 2024
• Study Completion: August 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

EG (1)