Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
- Conditions
- Cerebral Palsy
- Registration Number
- NCT04997109
- Lead Sponsor
- Emory University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 267
Inclusion Criteria:<br><br> - Aged 4 to 13 months, corrected age<br><br> - Patient at a participating neonatal intensive care unit (NICU) Early Developmental<br> Clinic, outpatient physical and occupational therapy clinic and stroke clinic<br><br> - Diagnosis of CP or classification of high-risk for CP as determined by published<br> guidelines (>95% risk of later CP)<br><br> - Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of greater than or<br> equal to 2 and/or neuroimaging consistent with perinatal involvement<br><br> - Hand Assessment for Infants (HAI) difference between hands =2, with an observable<br> and relative difference in quality or amount of movement between hands, as<br> determined by HAI-certified study therapists and/or a unimanual Bayley score<br> difference between hands >1<br><br> - Parent/legal guardian is able to provide informed consent<br><br>Exclusion Criteria:<br><br> - Congenital malformation of the brain or musculoskeletal system (MSK)<br><br> - Receipt of botulinum toxin to the affected extremity within 3 months of study entry<br><br> - Any prior long-term hard constraint programs
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score;Change in Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score
- Secondary Outcome Measures
Name Time Method Change in Infant Motor Activity Log (IMAL) How Often Score;Change in Hand Assessment in Infants (HAI) Score;Change in Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score;Change in Welch Emotional Connection Screen (WECS) Score;Change in Maternal Confidence Questionnaire (MCQ) Score