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

NCT06218316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

DRUG

botulinum toxin A

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.

DEVICE

Transcranial Magnetic Stimulation

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.

OTHER

Rehabilitation Training Protocol

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.

Sponsors & Collaborators

  • MTI University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2024-01-20
Completion
2024-08-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218316 on ClinicalTrials.gov