NCT03886792

Brachial Plexus Birth Palsy: Reinforcement Paradigm to Augment Recovery

A Home-Based Biofeedback Program to Augment Recovery After Perinatal Brachial Plexus Injury

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chapman University · Academic / Other
• Sex: All
• Age: 3 Months – 12 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Brachial Plexus Palsy

Interventions

Type	Name	Description
BEHAVIORAL	Triggered reinforcement	This group will participate in a home-based experimental intervention for 10 minutes, twice/day for 10 days within 2 weeks. The infants will be supported in sitting with a tray secured anterior to the trunk. This intervention will involve reinforcement of biceps muscle activation in the affected arm if the infant generates a muscle contraction above a pre-set threshold (V). The threshold needed to trigger a toy to move and make sounds (reinforcement) will be set at baseline as determined by surface electromyography (SEMG). During the training time-points, the parent or care-giver will be allowed to sing or talk to the infant but are not to shake the toys or place dowel-based rattles or toys in either palm of the infant.
BEHAVIORAL	Social interaction	This group will participate in a home-based dose-equivalent control intervention for 10 minutes, twice/day for 10 days within 2 weeks. The infants will be supported in sitting with a tray. This control program will combine social interaction between infant/parent with the opportunity for self-initiated play with toys repeatedly placed on the tray. A toy will be placed in front of the infant seat and tray but it will not be connected to the SEMG unit nor will the infant have an SEMG electrode attached over the biceps. During the intervention, the parent or care-giver will be allowed to sing or talk to the infant but are not to shake the toys or place dowel-based rattles or toys in either palm of the infant.

Timeline

• Start date: 2019-02-25
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-03-22
• Last updated: 2021-01-28

Locations

1 site across 1 country: United States