Training program for caregivers of infants with brachial plexus birth injury
Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
This study is testing a new training program for caregivers of infants with brachial plexus birth injury to see if it helps improve their babies' arm movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Academic / other |
| Locations | 2 sites (St. Petersburg, Florida and 1 other locations) |
| Trial ID | NCT06623357 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate a caregiver training protocol designed for those with infants suffering from brachial plexus birth injury (BPBI), a condition that can lead to arm paralysis or weakness. The study will recruit caregivers of infants up to 6 months old from two specialized clinics affiliated with Johns Hopkins Medicine. Participants will be randomly assigned to either a pilot training protocol or a standard training protocol, with the goal of improving the infants' range of motion through caregiver-led passive range of motion exercises. The study will gather preliminary data to assess the feasibility and effectiveness of the training program.
Who should consider this trial
Good fit: Ideal candidates are caregivers of infants aged 6 months or younger diagnosed with brachial plexus birth injury.
Not a fit: Patients who may not benefit include those with infants older than 6 months or those with co-morbidities that could complicate joint contractures.
Why it matters
Potential benefit: If successful, this training could enhance the motor function and quality of life for infants affected by brachial plexus birth injury.
How similar studies have performed: While this approach is novel in its specific focus on caregiver training for BPBI, similar interventions in other pediatric conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Caregiver, age 18+ of an infant age 6 months or younger with a confirmed BPBI determined by the brachial plexus clinic team at an infant's first visit Exclusion Criteria: * Caregiver of an infant older than 6 months of age scheduled at the brachial clinic Caregiver of an infant scheduled at the brachial plexus clinic with a diagnosis other than BPBI and/or co-morbidity known to cause joint contractures * Caregiver of infant with BPBI who requires surgery prior to nine months of age * Caregiver who does not speak English unless a JHMI interpreter is present at the clinic visit, at which point a short form consent will be used
Where this trial is running
St. Petersburg, Florida and 1 other locations
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (Recruiting)
- Kennedy Krieger Institute — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Matthew Elrick, MD, PhD — Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Study coordinator: Jennifer Wingrat, ScD, OTR/L
- Email: wingrat@kennedykrieger.org
- Phone: 4109679043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.