Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623357
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CTP-BPBI
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 andor delivery causing the nerves to stretch or tear occurs in 09 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 andor 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 eg 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 PROMstretching 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 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 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 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
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 PROMstretching 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 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 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 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 Childrens Hospital ACH in St Petersburg Florida Both clinics are led by investigator Dr Allan Belzberg the PI Dr Matt Elrick is the neurologist at KKIs clinic Co-investigator Jennifer Wingrat is the senior occupational therapist at KKI39s 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 caregivers cell phonetablet of the clinic-therapist andor 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 participants 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 infants 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 childs first follow-up visit resulting in two total study visits per participant
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 caregivers cell phonetablet of the clinic-therapist andor 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 participants 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 infants 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 childs first follow-up visit resulting in two total study visits per participant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None