Actively Recruiting
Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
Led by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Updated on 2026-03-03
20
Participants Needed
2
Research Sites
82 weeks
Total Duration
On this page
Sponsors
H
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Lead Sponsor
T
Towson University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates brachial plexus birth injury BPBI, a nerve injury occurring during labor or delivery that can cause arm paralysis or weakness and lead to joint contractures. These contractures limit shoulder movement and affect sensory-motor development, daily activities, and may require surgeries. The study aims to evaluate a new caregiver training method for performing passive range of motion PROM stretches, which may improve adherence and confidence in carrying out these exercises to reduce contracture risks in infants with BPBI. Participants will be randomly assigned to two groups Group A will receive a pilot training protocol including detailed checklists and guidance for PROM exercises, alongside visual handouts and video recordings, while Group B will receive the standard training currently used in clinics. Training occurs at the initial clinic visit, and caregivers are observed and given feedback on their PROM technique at a follow-up visit. The study is conducted at two specialized clinics with up to 20 caregiver-infant pairs enrolled over about a year. Caregivers will attend two study visits the first for training and initial assessment, and the second follow-up within 1 to 6 months to evaluate adherence, confidence, and efficacy in performing PROM. Researchers will collect data via surveys, checklist observations, and active movement assessments of the infants shoulder. All information will be kept confidential and securely stored. The trial will last up to three years with rolling enrollment until the target sample is reached.
CONDITIONS
Brief Title
Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Caregiver aged 18 years or older
- Caregiver of an infant aged 6 months or younger with confirmed brachial plexus birth injury (BPBI) diagnosed by the clinic team at the infant's first visit
You will not qualify if you...
- Caregiver of an infant older than 6 months scheduled at the brachial plexus clinic
- Caregiver of an infant with a diagnosis other than BPBI or with a co-morbidity known to cause joint contractures
- Caregiver of an infant with BPBI who requires surgery before nine months of age
- Caregiver who does not speak English unless a JHMI interpreter is present at the clinic visit
Research Team
J
Jennifer Wingrat, ScD, OTR/L
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