Clinical trial NCT03886792: Brachial Plexus Birth Palsy: Reinforcement Paradigm to Augment Recovery
Official title: A Home-Based Biofeedback Program to Augment Recovery After Perinatal Brachial Plexus Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brachial Plexus Palsy
Lead sponsor: Chapman University
Sponsor class: OTHER
Collaborators: name: American Society for Surgery of the Hand
First posted: 2019-03-22
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility Randomized Controlled Trial with one experimental and one control group
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age of 3 to 12 months with upper trunk brachial plexus birth palsy confirmed by an attending Hand and Upper Extremity Surgeon;
2. Full-term at birth;
3. A minimum score of '1' (0-7 scale) in elbow flexion of affected arm (isometric contraction) based on the Active Movement Scale (AMS);
4. Score ≥ 25th percentile on the motor subtest of the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSITD-III®);
5. Ability to sustain attention/arousal for a 10 minute training period based on criteria from the Neonatal Behavioral Assessment for an awake-alert state.

Exclusion Criteria:

1. Visual/auditory deficits;
2. Nerve repair/shoulder surgery;
3. Excessive crying during session(s);
4. Shoulder, elbow, or wrist joint contractures \> 20° in the affected arm;
5. An inability to trigger the musical-toy to play at baseline.

Primary outcomes:
measure: Change in the integral of biceps brachii muscle activation post-intervention
timeFrame: Baseline, Immediately post-intervention, 1-month post-intervention, 3-months post-intervention
Secondary outcomes:
measure: Change in day-long arm activity based on the resultant acceleration (ms*m/s2)
timeFrame: Baseline, Immediately post-intervention, 1-month post-intervention, 3-months post-intervention
measure: Parent Perception Questionnaire to examine feasibility of parent-run intervention - self designed
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
Study officials:
affiliation: Chapman University
name: Susan V Duff, EdD,PTOT,CHT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.