Brachial Plexus Birth Palsy: Reinforcement Paradigm to Augment Recovery

NAUnknownINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 25, 2019

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2021

Conditions
Brachial Plexus Palsy
Interventions
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.

Trial Locations (1)

90027

RECRUITING

Children's Hospital of Los Angeles, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

American Society for Surgery of the Hand

OTHER

lead

Chapman University

OTHER

NCT03886792 - Brachial Plexus Birth Palsy: Reinforcement Paradigm to Augment Recovery | Biotech Hunter | Biotech Hunter