Brachial Plexus Birth Palsy: Reinforcement Paradigm to Augment Recovery
Status unconfirmed · Not applicable
Conditions studied: Brachial Plexus Palsy
In brief
Infants who sustain an injury to the brachial plexus in the perinatal period are at high-risk for long-term neuromuscular deficits and prehensile dysfunction. If recovery is delayed because of slow axonal regrowth, disuse atrophy and secondary musculoskeletal deficits may develop. The investigators' hypothesis is that early, intensive intervention designed to foster muscle activation is essential to optimize outcomes after brachial plexus injury and may supplement rehabilitation and microsurgery. This proposal targets infants who are non-surgical candidates. Yet, future studies will examine whether the investigators' experimental intervention can hasten recovery from microsurgery and will examine which post-operative time-point is best to employ it. The investigators' intervention shows promise to increase muscle activation and improve arm function in infants with brachial plexus birth palsy (BPBP) through contingent reinforcement based on a pilot study.
Key facts
- Study ID
- NCT03886792
- Run by
- Chapman University
- People needed
- 24
- Starts
- 2019-02-25
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2021-01-28
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age of 3 to 12 months with upper trunk brachial plexus birth palsy confirmed by an attending Hand and Upper Extremity Surgeon;
- Full-term at birth;
- A minimum score of '1' (0-7 scale) in elbow flexion of affected arm (isometric contraction) based on the Active Movement Scale (AMS);
- Score ≥ 25th percentile on the motor subtest of the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSITD-III®);
- Ability to sustain attention/arousal for a 10 minute training period based on criteria from the Neonatal Behavioral Assessment for an awake-alert state.
You may not qualify if…
- Visual/auditory deficits;
- Nerve repair/shoulder surgery;
- Excessive crying during session(s);
- Shoulder, elbow, or wrist joint contractures > 20° in the affected arm;
- An inability to trigger the musical-toy to play at baseline.
Where it is running
- Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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