Currently submitted to: JMIR Research Protocols
Date Submitted: Jan 22, 2026
Open Peer Review Period: Jan 26, 2026 - Mar 23, 2026
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Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury: Protocol for a Multi-Center Randomized Clinical Trial
ABSTRACT
Background:
Brachial plexus birth injury (BPBI) occurs in approximately one of 1,000 live births resulting in long-term limitations in upper extremity function including shoulder contracture. Early intervention with passive range of motion (PROM) performed by caregivers multiple times per day is commonly recommended to prevent the development of shoulder contracture. Research shows that common barriers to adherence to this daily PROM recommendation includes caregiver lack of confidence and fear of hurting their child. Objectives: 1) determine whether caregivers who receive a Coaching training protocol for performing PROM demonstrate improved efficacy in performing PROM compared to caregivers who receive standard training; and 2) determine whether caregivers who receive a Coaching training protocol for performing PROM demonstrate improved self-confidence in performing PROM compared to caregivers who receive standard training.
Methods:
This prospective, multi-site randomized clinical trial will evaluate the efficacy of a caregiver training protocol that uses principles of coaching and guided discovery to enhance confidence and problem-solving needed to overcome barriers to adherence. Caregivers of infants with BPBI will be randomized to receive either standard PROM training or the Coaching-based protocol. Caregiver efficacy, self-reported self-confidence, self-reported frequency of performing PROM, and facilitators and barriers to adherence will be compared between the two groups. Findings will be used to determine whether the Coaching protocol is superior for facilitating caregiver efficacy and confidence and subsequently supports daily PROM adherence. Conclusion: If effective, this protocol will be integrated into a larger non-inferiority trial to assess the minimum daily frequency of PROM needed to decrease the risk of shoulder contracture. This study addresses a critical gap in evidence-based standards for early intervention for infants with BPBI and aims to improve long-term functional outcomes for affected infants and their families.
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