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RECRUITING
NCT04997109
NA

Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

Sponsor: Emory University

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

4 Months - 13 Months

Study Type

INTERVENTIONAL

Enrollment

267

Start Date

2022-02-23

Completion Date

2027-02-28

Last Updated

2025-10-14

Healthy Volunteers

No

Conditions

Interventions

OTHER

APPLES-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.

BEHAVIORAL

Parent-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.

BEHAVIORAL

Standard 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.

Locations (4)

Emory University

Atlanta, Georgia, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

The University of Utah

Salt Lake City, Utah, United States