Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT03237520
Eligibility Criteria:
Inclusion Criteria:
1. Children aged \>5-18 years
2. Children with hemiparetic cerebral palsy \* (both perinatal and postnatal acquired brain injury)
3. Intelligence quotient \>70 (Binet Kamat Test/Malin's Intelligence Scale for Children)
4. Modified Ashworth scoring 1-3 for affected limb
5. Can sit independently or with support (Gross Motor Functional Classification System stage: 1-4 and Manual Ability Classification System stage: 1-3)
6. Preserved vision and hearing (with or without correction)
Exclusion Criteria:
1. Uncontrolled epilepsy as defined by seizure frequency \>1/month for preceding 3 months
2. Severe concurrent illness or diseases not associated with CP or unstable medical conditions like pneumonia
3. Genetic or syndromic associations
4. Children diagnosed with autistic spectrum disorders
5. Modified Ashworth scale score more than 3 at shoulder/elbow /wrist
6. Contractures of the affected limb
7. Severe movement disorder like dystonia, choreo-athetosis or ballismus interfering with purposeful limb movement
8. Any congenital brain malformation detected on conventional MRI brain
9. Recent orthopedic surgery/cast/splint in the affected limb
10. Botulinum toxin/phenol blocking in the affected limb in the past 6 months or are planning to receive in the study period
11. Those receiving tone modifying agents in week before enrollment(Tizanidine,baclofen,benzodiazepines,dantrolene)
12. Any contraindications for MRI - examples- presence of pacemaker, metallic implant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT03237520
Study Brief:
Protocol Section:
NCT03237520