Status:
UNKNOWN
Evaluation of Repetitive Transcranial Magnetic Stimulation as an Adjunct to Modified Constraint Induced Movement Therapy in Improving Upper Limb Function in Children With Hemiparetic Cerebral Palsy Aged 5 - 18 Years
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Hemiparetic Cerebral Palsy
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
The investigators aim to evaluate efficacy of TMS as an adjunct to CIMT, assess its safety and tolerability and study cortical excitability with help of TMS which are both rehabilitative therapies for...
Detailed Description
Cerebral palsy is the most common motor disability of childhood and Hemiparetic cerebral palsy accounts for about one third of cases. Improving spasticity and upper limb function in these children can...
Eligibility Criteria
Inclusion
- • Age 5 - 18 years
- Hemiparetic Cerebral Palsy (perinatal brain injury)
- Intelligence Quotient \>70 (Binet Kamat Test/Malin's Intelligence Scale for Children)
- Modified Ashworth scoring 1-3 for affected limb
- Can sit independently or with support (GMFCS stage : 1-4 and Manual Ability Classification System stage: 1-3)
- Preserved vision and hearing (with or without correction)
Exclusion
- • Uncontrolled epilepsy as defined by seizure frequency \>1/month for preceding 3 months
- Severe concurrent illness or disease not associated with CP or unstable medical conditions like pneumonia
- Genetic or syndromic associations
- Children diagnosed with Autistic Spectrum Disorders
- Modified Ashworth Scale Score more than 3 at shoulder/elbow/wrist
- Contractures of affected limb
- Severe movement disorder like dystonia, choreo-athetosis or ballismus interfering with purposeful limb movement
- Any congenital brain malformation detected on conventional MRI brain
- Recent surgery/cast/splint in affected limb
- Botulinum toxin/phenol block in affected limb in past 6 months or planned to receive in study period
- Those receiving tone modifying agents within two weeks before enrolment (Tizanidine, baclofen, benzodiazepines, dantrolene)
- mCIMT received in last 6 months
- Any contraindications for TMS - implanted electronic device and non-removable metallic objects near coil e.g. Pacemaker, cochlear implant
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03792789
Start Date
January 15 2019
End Date
August 30 2020
Last Update
January 3 2019
Active Locations (1)
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1
India
New Delhi, India, 110029