Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06218316 |
Other study ID # |
cairo university |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 15, 2023 |
Est. completion date |
January 20, 2024 |
Study information
Verified date |
January 2024 |
Source |
MTI University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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).
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