RecruitingNot ApplicableNCT04997109

Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

Sponsor

Emory University

Enrollment

267 participants

Start Date

Feb 23, 2022

Study Type

INTERVENTIONAL

Conditions

Cerebral Palsy

Summary

This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.

Eligibility

Min Age: 4 MonthsMax Age: 13 Months

Inclusion Criteria5

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 Criteria3

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

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Interventions

OTHERAPPLES-tele

The APPLES-tele intervention is 5 weekly telehealth sessions of therapist-demonstrated tasks, delivered over a 6 week period. Infant participants wear a soft-constraint harness (C-Mitt) on their less affected arm for 6 hours per day, while their parent encourages them to use their more affected arm to complete play-based activities as instructed by the study therapist. As the infant experiences success, heavier objects are provided. During times when the C-Mitt is not worn, parents engage therapist-demonstrated bimanual play of increasing difficulty.

BEHAVIORALParent-centered Approach (PCA) Support Intervention

The PCA support intervention is 5 weekly telehealth sessions delivered over a 6 week period. The PCA curriculum includes 5 basic principles of positive parenting from Triple P: ensuring a safe engaging environment, creating a positive learning environment, using assertive discipline, having reasonable expectations, and looking after yourself as a parent. All of these elements, when taught to parents in an individualized manner, can help promote responsivity, structure and expectations that are tailored to their child's condition and developmental stage. In addition, a curriculum of CP-specific knowledge will address the challenges unique to parents of children with CP, such as understanding principles of infant learning of new movements, challenges and solutions for self-directed activity in infants with CP.

BEHAVIORALStandard of Care

Participants will receive the usual care from being followed in high-risk infant follow-up (HRIF) programs in the Early Detection and Intervention (EDI) Network.