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Clinical Trial Summary

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.


Clinical Trial Description

The investigator's study objectives are to (1) test the feasibility of a parent-lead in-home 2-week intervention for infants with BPBP; and (2) determine the effect size for the primary outcome measure(s) in preparation for a future definitive randomized controlled trial (RCT). In this feasibility RCT, the investigators will compare two in-home interventions in 3 to 12-month-old infants with upper trunk BPBP; n=12 per group: (1) experimental; and (2) dose-equivalent active control. For the experimental intervention, infants will trigger a musical toy to move and play via biceps contraction above a preset individual threshold. For the control intervention, toys will be available to play with, yet, there will be no reinforcement for biceps activation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03886792
Study type Interventional
Source Chapman University
Contact Susan V Duff, EdD, PT, OT
Phone (714) 977-6704
Email duff@chapman.edu
Status Recruiting
Phase N/A
Start date February 25, 2019
Completion date December 31, 2021

See also
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Completed NCT06415747 - Early Pain Finding in Infants With Brachial Plexus Birth Injury
Completed NCT04243590 - Turkish Version of Hand-Use-at-Home Questionnaire