Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury

NCT06623357 | Recruiting

• 1 other identifier: IRB00450720
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The brachial plexus is a network of nerves that exit the spinal cord from the C5-T1 nerve roots and provide all motor and sensory function to the arm from the shoulder to the fingers. Injury to the brachial plexus due to traction forces during labor and/or delivery causing the nerves to stretch or tear occurs in 0.9 out of 1000 live births. As many as 30% of infants with brachial plexus birth injury (BPBI) have paralysis or weakness in one arm resulting in lifelong impairment in arm function with joint contractures, the shortening of tendons, ligaments and muscles, leading to reduced range of motion (ROM), being a common complication and major source of disability. A primary goal of early management of BPBI is to use passive range of motion (PROM) (stretching) to improve and/or maintaining shoulder ROM due to the known risk of shoulder contracture within the first year of life. Infants who develop contractures face challenges in overall sensory-motor development and are less able to participate in meaningful occupations and activities of daily living due to limited upper extremity ROM. They are also at risk for subsequent surgeries throughout their lives. Occupational therapy practitioners (OTPs) and physicians who specialize in treating infants with BPBI recommend caregivers to perform PROM at every diaper change, which is every 1-3 hours in the first months of life, and every 4-6 hours by age one. A survey study by one of the investigators on this proposed project found that 85% of OTPs who specialize in BPBI make this recommendation for performing PROM at every diaper change; however, there is no research to support this frequency to prevent or decrease contractures. Clinical observations suggest that infants who receive consistent daily PROM seem to avoid development of shoulder contractures while those who receive no or infrequent PROM seem to develop early and significant contractures. In a retrospective pilot study we found that children whose parents consistently performed PROM two times daily starting before age two months were less likely to develop shoulder contractures than children whose parents were inconsistent in performing PROM. These findings, along with our clinical observations suggest that frequency of PROM might be less important than consistency. In order to assess the efficacy of different levels of frequency (e.g., at every diaper change vs. two times per day), it is imperative to identify methods that support caregivers in performing PROM every day. Therefore, the proposed study will pilot a caregiver training method which, if successful in facilitating daily adherence, will be used as part of a larger planned study that will compare differences in recommended frequencies of stretching. In a survey study and scoping literature review performed by one of the co-investigators on this project, caregiver adherence to home therapy recommendations was found to be facilitated by confidence in the training they received and by their confidence in ability to carry-out recommendations; lack of confidence in performing the home therapy recommendations was found to be a common barrier. Therefore, the objective of the proposed work is to assess the efficacy of a pilot training protocol for caregivers of infants with BPBI. Our central hypothesis is that the pilot training protocol will improve caregiver efficacy and increase their confidence in performing the recommended PROM/stretching procedure, thus facilitating adherence which we hope to later demonstrate will decrease the risk of shoulder contracture in infants with BPBI. The significance of this work is that it will evaluate and provide evidence for the use of the pilot training protocol so that this training protocol can later be used in a larger study on the efficacy of different frequencies of PROM to reduce the development of shoulder contracture in infants with BPBI, and thus contribute to developing evidenced-based standards of care for this population. The objectives of this clinical trial are to:

1. 1.determine whether caregivers who receive a pilot training protocol for performing PROM demonstrate improved efficacy in performing PROM compared to caregivers who receive standard training
2. 2.determine whether caregivers who receive a pilot training protocol for performing PROM demonstrate improved self-confidence in performing PROM compared to caregivers who receive standard training
3. 3.determine whether caregivers who receive a pilot training protocol for performing PROM report better daily adherence to daily PROM compared to caregivers who receive standard training

Conditions

Brachial Plexus Birth Palsy; Erbs Palsy

Keywords

Brachial Plexus Birth Injury; Brachial Plexus; Passive Range of Motion; Caregiver Education; Caregiver Training; Contracture

Outcome Measures

Primary Outcomes (1)

• Caregiver Efficacy and Self-Confidence

  Caregiver efficacy and self-confidence will be measured using surveys completed after their initial training and again at their child\'s follow-up clinic visit. Average scores will be computed for all surveys and independent t-tests will compare differences in mean scores for caregiver efficacy and self-confidence for the group receiving the pilot training and the group receiving the standard training.

  From enrollment at initial visit to first follow up visit within 1-6 months

Secondary Outcomes (1)

• Caregiver self-report of frequency of daily PROM (stretching)

  From enrollment until first follow-up visit at 1-6 months

Study Arms (2)

Group A - Pilot Protocol

EXPERIMENTAL

Participants in Group A will receive training in PROM techniques via a visual handout with pictures and written instructions and video recording using the caregiver's cell phone/tablet of the trainer and/or caregiver performing PROM on the infant. Participants in Group A will also receive supplemental training including a step-by-step checklist for each of the shoulder stretches that are recommended and will be instructed to refer to the checklist each time they perform PROM at home. Participants will be observed performing PROM at their initial visit where training occurs and at their infants' next follow-up visit. The standardized checklist will be used to assess efficacy of caregivers' demonstrated PROM including assessment of positioning, hand placement, and number of cues needed to facilitate accuracy; specific feedback will be given as needed.

Other: Pilot Training Protocol

Group B - Standard Protocol

ACTIVE COMPARATOR

Participants in Group B will receive training in PROM techniques via the same visual handout with pictures and written instructions provided to Group A as well as video recording using the caregiver's cell phone/tablet of the trainer and/or caregiver performing PROM on the infant.

Other: Standard Training Protocol

Interventions

Pilot Training Protocol OTHER

The pilot training protocol uses principles based on evidence-based research on factors that support caregiver learning of and adherence to home-therapy techniques/recommendations.

Group A - Pilot Protocol

Standard Training Protocol OTHER

The standard training protocol uses the caregiver training methods that are currently used in our clinics.

Group B - Standard Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver, age 18+ of an infant age 6 months or younger with a confirmed BPBI determined by the brachial plexus clinic team at an infant's first visit

You may not qualify if:

• Caregiver of an infant older than 6 months of age scheduled at the brachial clinic Caregiver of an infant scheduled at the brachial plexus clinic with a diagnosis other than BPBI and/or co-morbidity known to cause joint contractures
• Caregiver of infant with BPBI who requires surgery prior to nine months of age
• Caregiver who does not speak English unless a JHMI interpreter is present at the clinic visit, at which point a short form consent will be used

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Towson University: collaborator

Study Sites (2)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (4)

• Smith BW, Daunter AK, Yang LJ, Wilson TJ. An Update on the Management of Neonatal Brachial Plexus Palsy-Replacing Old Paradigms: A Review. JAMA Pediatr. 2018 Jun 1;172(6):585-591. doi: 10.1001/jamapediatrics.2018.0124.

  PMID: 29710183 BACKGROUND

• Wingrat J, Price C, Wright T. Facilitators of and Barriers to Caregiver Adherence to Home Therapy Recommendations for Infants and Children With Neuromotor and Neuromuscular Diagnoses: A Scoping Review. Am J Occup Ther. 2024 Sep 1;78(5):7805205070. doi: 10.5014/ajot.2024.050567.

  PMID: 39083636 BACKGROUND

• Wingrat J, Elrick MJ. Frequency, facilitators, and barriers for range of motion to prevent shoulder contracture in brachial plexus birth injury: A pilot study. J Pediatr Rehabil Med. 2023;16(2):331-336. doi: 10.3233/PRM-220090.

  PMID: 37005904 BACKGROUND

• DeFrancesco CJ, Shah DK, Rogers BH, Shah AS. The Epidemiology of Brachial Plexus Birth Palsy in the United States: Declining Incidence and Evolving Risk Factors. J Pediatr Orthop. 2019 Feb;39(2):e134-e140. doi: 10.1097/BPO.0000000000001089.

  PMID: 29016426 BACKGROUND

MeSH Terms

Conditions

Brachial Plexus Neuropathies; Contracture

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases

Study Officials

• Matthew Elrick, MD, PhD

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Wingrat, ScD, OTR/L

CONTACT

4109679043; wingrat@kennedykrieger.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Neurologist

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)