Status:
UNKNOWN
Comparing Virtual Reality Therapy With Modified-CIMT Versus Modified-CIMT Alone in Hemiparetic Children
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Hemiparesis
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
This study intends to compare the efficacy of of virtual reality therapy(VRT) with modified constraint induced movement therapy(mCIMT) versus modified constraint induced movement therapy alone for chi...
Detailed Description
Sample size: Based on the previous studies, on CIMT in hemiparetic CP children using QUEST scores, * Anticipated increase in total QUEST scores at 2 months in the mCIMT group: 10 + 5(mean + SD) * ...
Eligibility Criteria
Inclusion
- Children aged \>5-18 years
- Children with hemiparetic cerebral palsy \* (both perinatal and postnatal acquired 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 (Gross Motor Functional Classification System 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 diseases 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 the 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 orthopedic surgery/cast/splint in the affected limb
- Botulinum toxin/phenol blocking in the affected limb in the past 6 months or are planning to receive in the study period
- Those receiving tone modifying agents in week before enrollment(Tizanidine,baclofen,benzodiazepines,dantrolene)
- Any contraindications for MRI - examples- presence of pacemaker, metallic implant
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03237520
Start Date
September 1 2017
End Date
August 1 2018
Last Update
August 10 2017
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