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Completed
NCT04997109
Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
Conditions: Cerebral Palsy
Sex: All
Ages: 4 Months – 13 Months
Healthy volunteers: No
Phase: NA
Enrollment: 269
Sponsor: Emory University
Location: Emory University Atlanta Georgia
Summary
This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.
Eligibility Criteria
Inclusion Criteria:
* Aged 4 to 13 months, corrected age
* Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (\>95% risk of later CP)
* Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of greater than or equal to 2 and/or neuroimaging consistent with perinatal involvement
* Hand Assessment for Infants (HAI) difference between hands ≥2, with an observable and relative difference in quality or amount of movement between hands, as determined by HAI-certified study therapists and/or a unimanual Bayley score difference between hands \>1
* Parent/legal guardian is able to provide informed consent
Exclusion Criteria:
* Congenital malformation of the brain or musculoskeletal system (MSK)
* Receipt of botulinum toxin to the affected extremity within 3 months of study entry
* Any prior long-term hard constraint programs
Source: ClinicalTrials.gov (NCT04997109). StuddyBuddy aggregates publicly available trial information.