Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury

The proposed project is a prospective multi-site randomized trial. Participants will be recruited from two JHMI affiliated multidisciplinary brachial plexus clinics: Kennedy Krieger Institute (KKI) and Johns Hopkins All Children's Hospital (ACH) in St. Petersburg, Florida. Both clinics are led by investigator, Dr. Allan Belzberg; the PI Dr. Matt Elrick is the neurologist at KKI's clinic. Co-investigator Jennifer Wingrat is the senior occupational therapist at KKI's clinic and Lisa Tetreault is Clinic Coordinator at ACH. Both clinics meet monthly with an average of two new patients and up to 10 follow-up patients per clinic each month. Caregivers of all new patients up to 6 months of age will be eligible to enroll in the study, with enrollment continuing until we reach 20 participants, which we anticipate will occur within 12 months. The sample size of 20 was chosen due to the feasibility of recruiting participants based on the typical demographics of the two clinics from which participants are being recruited; because this is a pilot study, the sample size should be sufficient to provide preliminary data. As recruitment will occur on a rolling basis, no interim data analyses are planned.

When a new patient is scheduled at either of the JHMI brachial plexus clinics, J. Wingrat or Lisa Tetreault will contact the primary caregiver via phone or email to describe the study and to obtain verbal consent; virtual meeting via FaceTime or Zoom will be offered to provide information about the study if desired. Signed consent will be obtained when the caregiver brings their child to their first scheduled clinic appointment. Enrolled caregivers will be randomly assigned to one of two equally sized intervention groups. Group A will be instructed in the pilot PROM training protocol and Group B will receive standard training. Caregiver instruction in PROM provided by the occupational therapist is part of routine care for all infants with a BPBI seen in the clinic.

Per routine clinic protocol, all caregivers 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 clinic-therapist and/or caregiver performing PROM on the infant. The caregivers of infants in group A, the pilot training group, will receive supplemental training including a step-by-step checklist for each of the shoulder stretches that are recommended. Caregivers in Group A will be instructed to refer to the checklist each time they perform PROM at home. J. Wingrat and or L. Tetreault will provide the training at each participant's first clinic visit.

Caregivers 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 the efficacy of caregivers' demonstrated PROM which includes assessment of positioning, hand placement, and number of cues needed to facilitate accuracy. Caregivers in Group A (the pilot group) will receive specific feedback based on the checklist. Caregivers' perception of self-confidence will be measured using a survey after initial training is provided and at their infant's next follow-up visit; the follow-up survey will also ask caregivers to self-report how frequently they performed PROM. Per routine clinic protocol, active range of motion will be assessed and documented for all infants using the Active Movement Scale at the initial visit and again at the follow-up visit. All data will be entered into a de-identified data record form and stored in a password-protected file in the JHMI SAFE Desktop application. The study will be stopped early if the researchers become aware of new evidenced-based data on a caregiver training protocol for PROM for infants with BPBI.

Study duration will be up to three years with rolling enrollment of caregivers of newly referred infants as they are referred to either of the two clinics. Caregivers of infants between birth and 6 months of age will be eligible for enrollment and will remain enrolled until their child's first follow-up visit, resulting in two total study visits per participant.

Inclusion criteria

• 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

Exclusion criteria

• 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