Brachial Plexus Birth Palsy: Reinforcement Paradigm to Augment Recovery

NCT03886792 | Unknown

• 1 other identifier: 1408
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brachial Plexus Palsy

Outcome Measures

Primary Outcomes (1)

• Change in the integral of biceps brachii muscle activation post-intervention

  Change in the magnitude of biceps muscle activation (Volts x time) post-intervention

  Baseline, Immediately post-intervention, 1-month post-intervention, 3-months post-intervention

Secondary Outcomes (2)

• Change in day-long arm activity based on the resultant acceleration (ms*m/s2)

  Baseline, Immediately post-intervention, 1-month post-intervention, 3-months post-intervention

• Parent Perception Questionnaire to examine feasibility of parent-run intervention - self designed

  Immediately post-intervention

Study Arms (2)

Triggered Reinforcement

EXPERIMENTAL

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: Triggered reinforcement

Social Interaction

SHAM COMPARATOR

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.

Behavioral: Social interaction

Interventions

Triggered reinforcement BEHAVIORAL

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.

Triggered Reinforcement

Social interaction BEHAVIORAL

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.

Social Interaction

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Chapman University: lead
• American Society for Surgery of the Hand: collaborator

Study Sites (1)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Related Publications (4)

• Duff SV, Sargent B, Kutch JJ, Berggren J, Leiby BE, Fetters L. Using Contingent Reinforcement to Augment Muscle Activation After Perinatal Brachial Plexus Injury: A Pilot Study. Phys Occup Ther Pediatr. 2017 Oct 20;37(5):555-565. doi: 10.1080/01942638.2017.1290733. Epub 2017 Apr 20.

  PMID: 28426263 RESULT

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.

  PMID: 27965879 RESULT

• Foad SL, Mehlman CT, Ying J. The epidemiology of neonatal brachial plexus palsy in the United States. J Bone Joint Surg Am. 2008 Jun;90(6):1258-64. doi: 10.2106/JBJS.G.00853.

  PMID: 18519319 RESULT

• Sullivan GM, Artino AR Jr. Analyzing and interpreting data from likert-type scales. J Grad Med Educ. 2013 Dec;5(4):541-2. doi: 10.4300/JGME-5-4-18. No abstract available.

  PMID: 24454995 RESULT

MeSH Terms

Interventions

Drug Interactions

Intervention Hierarchy (Ancestors)

Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Susan V Duff, EdD,PTOT,CHT

  Chapman University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan V Duff, EdD, PT, OT

CONTACT

(714) 977-6704; duff@chapman.edu

Jamie Berggren, OTR/L

CONTACT

(323) 361-4165; jberggren@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blind to treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility Randomized Controlled Trial with one experimental and one control group

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 22, 2019
• Study Start: February 25, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)