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Clinical Trial 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).


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06218316
Study type Interventional
Source MTI University
Contact
Status Enrolling by invitation
Phase N/A
Start date October 15, 2023
Completion date January 20, 2024

See also
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Completed NCT00261131 - Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy Phase 3
Active, not recruiting NCT00356343 - Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy Phase 1
Completed NCT00255073 - Does Reducing Spasticity Permit an Increase in Strength? Phase 2
Recruiting NCT05504798 - A New Multimodal Treatment Approach for Children With Spastic Diplegic Cerebral Palsy N/A