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NCT06623357 · ClinicalTrials.gov registry record · NA
Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
A NA study of Brachial Plexus Birth Palsy and Erbs Palsy, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06623357: Recruiting NA study of Brachial Plexus Birth Palsy and Erbs Palsy, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
NCT06623357 is a NA study of Brachial Plexus Birth Palsy and Erbs Palsy that is actively recruiting participants, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06623357, a NA study of Brachial Plexus Birth Palsy and Erbs Palsy, is actively recruiting participants, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
The brachial plexus is a network of nerves that exit the spinal cord from the C5-T1 nerve roots and provide all motor and sensory function to the arm from the shoulder to the fingers. Injury to the brachial plexus due to traction forces during labor and/or delivery causing the nerves to stretch or tear occurs in 0.9 out of 1000 live births. As many as 30% of infants with brachial plexus birth injury (BPBI) have paralysis or weakness in one arm resulting in lifelong impairment in arm function with joint contractures, the shortening of tendons, ligaments and muscles, leading to reduced range of motion (ROM), being a common complication and major source of disability. A primary goal of early management of BPBI is to use passive range of motion (PROM) (stretching) to improve and/or maintaining shoulder ROM due to the known risk of shoulder contracture within the first year of life. Infants who develop contractures face challenges in overall sensory-motor development and are less able to participate in meaningful occupations and activities of daily living due to limited upper extremity ROM. They are also at risk for subsequent surgeries throughout their lives. Occupational therapy practitioners (OTPs) and physicians who specialize in treating infants with BPBI recommend caregivers to perform PROM at every diaper change, which is every 1-3 hours in the first months of life, and every 4-6 hours by age one. A survey study by one of the investigators on this proposed project found that 85% of OTPs who specialize in BPBI make this recommendation for performing PROM at every diaper change; however, there is no research to support this frequency to prevent or decrease contractures. Clinical observations suggest that infants who receive consistent daily PROM seem to avoid development of shoulder contractures while those who receive no or infrequent PROM seem to develop early and significant contractures. In a retrospective pilot study we found that children whose parents consist
Primary Outcome
Caregiver efficacy and self-confidence will be measured using surveys completed after their initial training and again at their child\'s follow-up clinic visit. Average scores will be computed for all surveys and independent t-tests will compare differences in mean scores for caregiver efficacy and self-confidence for the group receiving the pilot training and the group receiving the standard training.
Conditions Studied
Interventions
- OTHER Pilot Training Protocol
- OTHER Standard Training Protocol
Study Locations (2)
Florida
- Johns Hopkins All Children's Hospital - St. Petersburg
Maryland
- Kennedy Krieger Institute - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT06623357 shows while recruiting
NCT06623357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Brachial Plexus Birth Palsy appearing as the primary indexed condition, and to 2 interventions - of which Pilot Training Protocol is the first listed.
NCT06623357 reports a single indexed study location in Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT06623357 about?
NCT06623357 is a clinical study titled "Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury". The brachial plexus is a network of nerves that exit the spinal cord from the C5-T1 nerve roots and provide all motor and sensory function to the arm from the shoulder to the fingers. Injury to the brachial plexus due to traction forces during labor and/or delivery causing the nerves to stretch or t...
What is the current status of trial NCT06623357?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-01-01. Estimated completion is 2027-12-31.
What conditions does trial NCT06623357 study?
This clinical trial studies the following conditions: Brachial Plexus Birth Palsy, Erbs Palsy.
What interventions are being tested in trial NCT06623357?
The interventions under investigation include: Pilot Training Protocol (OTHER), Standard Training Protocol (OTHER).
Who is sponsoring clinical trial NCT06623357?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06623357 being conducted?
This trial has 2 study locations across Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06623357's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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