About this trial
This RCT aims to investigate the effect of repetitive transcranial magnatic stimulation (rTMS) in treating children with hemiplegoc cerebral palsy. The study will measure any improvement in spasticity after using contra-lesional inhibitory rTMS follow by intensive limb training.
Participants will attend a 10-day rTMS treatment sessions, follow by intensive training of the impaired limb. They will also undergo MRI scans before and after the treatment to investiagte the underlying neurophysiological mechanisms that lead to changes clinically by using TMS as well as MR-DKI. Researchers will compare the intervention group and the sham group to see if rTMS could result in improvement of participants' spasticity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 7 years and 18 years
Diagnosis of cerebral palsy with hemiplegia
Upper limb spasticity ≥ 1
IQ ≥ 50
Disqualifiers
Any contra-indications to rTMS
Severe spasticity (score of 4 or more in Ashworth scale)
Uncontrollable epilepsy
History of Botulinum toxin A injection in previous 6 months
Trial design
Parallel
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation
Device1 Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training
Sham Repetitive Transcranial Magnetic Stimulation
DeviceSham Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training
Treatment groups
Trial outcomes
Primary outcomes
Modified Ashworth Scale
Clinical measure of spasticity. Scores range from 0 to 4, with a higher score indicate worse in muscle tone
The range of motion scores
ROM of thumb adduction, wrist dorsal flexion and extension, and elbow dorsal flexion and extension. Patients' range of motion score will be compared to the normative values
Secondary outcomes
Zancolli scale
Severity of forearm alignment. Scores range from 0 to 3 with a higher score indicate worse hand function
House functional classification scale
Rating of functional use of the impaired upper limb. Scale consists of nine grades from 0 (does not use) to 8 (full spontaneous use)
Gross motor function measure
Changes in motor function. A 4-point Likert scale with higher score indicates better motor function
Assisting hand assessment
Test of hand function
Sponsors and contacts
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