Brachial Plexus Birth PalsyCTP-BPBINCT06623357
Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
A study testing Pilot Training Protocol and Standard Training Protocol in people with Brachial Plexus Birth Palsy and Erbs Palsy, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brachial Plexus Birth Palsy, Erbs Palsy
- What is being tested?
- Pilot Training Protocol and Standard Training Protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Jennifer Wingrat, ScD, OTR/L, 443-898-9800, wingrat@kennedykrieger.org
Matt Elrick, MD, PhD, 443-923-9525, elrick@kennedykrieger.org
- Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Lisa Tetreault, BSN, RN, CCRP, 727-767-4881, ltetrea2@jhmi.edu
Jennifer Wingrat, ScD, OTR/L, wingrat@kennedykrieger.org
About this study
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.
Read more
The objectives of this clinical trial are to:
- 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
- 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
- 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
Read the detailed description
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.
- Conditions
- Brachial Plexus Birth Palsy, Erbs Palsy
- Being tested
- Pilot Training Protocol, Standard Training Protocol
- Keywords
- Brachial Plexus Birth Injury, Brachial Plexus, Passive Range of Motion, Caregiver Education, Caregiver Training, Contracture
- Medical subject headings
- Brachial Plexus Neuropathies, Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot Training ProtocolOther
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.
Standard Training ProtocolOther
The standard training protocol uses the caregiver training methods that are currently used in our clinics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Training Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Independent t-tests will compare number of times per day PROM was performed as reported by participants in each group. 2. Correlation coefficients will be computed to assess relationship between caregiver self-reported efficacy and number of times per day that PROM was performed, and 2) care-giver self-reported confidence and number of times per day that PROM was performed
Measured: From enrollment until first follow-up visit at 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus Birth PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Towson University
- Responsible party
- Principal investigator, Matthew Elrick, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Matthew Elrick, MD, PhD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623357
- Sponsor's protocol ID
- IRB00450720
- Acronym
- CTP-BPBI
- Status last verified
- Feb 2026
- First submitted
- 30 Sep 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study outcomes will be reported in the aggregate
Publications
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.
PubMed 29710183Wingrat 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.
PubMed 39083636Wingrat 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.
PubMed 37005904DeFrancesco 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.
PubMed 29016426
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
- ClinicalTrials.gov ID
- NCT06623357
- Acronym / sponsor ID
- CTP-BPBI / IRB00450720
- Conditions
- Brachial Plexus Birth Palsy, Erbs Palsy
- Keywords
- Brachial Plexus Birth Injury, Brachial Plexus, Passive Range of Motion, Caregiver Education, Caregiver Training, Contracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- Towson University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
- 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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Pilot Protocol | Experimental | Other: Pilot Training ProtocolParticipants 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. |
| Group B - Standard Protocol | Active comparator | Other: Standard Training ProtocolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilot Training ProtocolThe pilot training protocol uses principles based on evidence-based research on factors that support caregiver learning of and adherence to home-therapy techniques/recommendations. | Other | Group A - Pilot Protocol |
| Standard Training ProtocolThe standard training protocol uses the caregiver training methods that are currently used in our clinics. | Other | Group B - Standard Protocol |
Primary outcome
Caregiver Efficacy and Self-Confidence
Time frame: From enrollment at initial visit to first follow up visit within 1-6 months
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.
1 secondary outcome
Caregiver self-report of frequency of daily PROM (stretching)
Time frame: From enrollment until first follow-up visit at 1-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 29710183Smith 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.
- Background: PubMed 39083636Wingrat 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.
- Background: PubMed 37005904Wingrat 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.
- Background: PubMed 29016426DeFrancesco 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.
- Individual participant dataSharing planned: No. All study outcomes will be reported in the aggregate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Elrick, MD, PhD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilot Training Protocol and Standard Training Protocol in people with Brachial Plexus Birth Palsy and Erbs Palsy, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Wingrat, ScD, OTR/L (4109679043, wingrat@kennedykrieger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Efficacy and Self-Confidence (time frame: From enrollment at initial visit to first follow up visit within 1-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06623357, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.