Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Training program for caregivers of infants with brachial plexus birth injury

Official title: Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury

Run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · NCT06623357 · Data updated 2026-11-12

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.

More Brachial Plexus Birth Palsy trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
Academic / other
Locations2 sites (St. Petersburg, Florida and 1 other locations)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedJune 2026
Study endsDecember 31, 2027
Registry record updatedMarch 3, 2026
Trial IDNCT06623357 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are caregivers of infants aged 6 months or younger diagnosed with brachial plexus birth injury.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While this approach is novel in its specific focus on caregiver training for BPBI, similar interventions in other pediatric conditions have shown promising results.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.