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Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

NCT04997109 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2025-10-14

No results posted yet for this study

Summary

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

Conditions

  • Cerebral Palsy

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Nathalie Maitre, MD, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
4 Months
Max Age
13 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2026-08-31
Completion
2027-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997109 on ClinicalTrials.gov