Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835376
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2021-04-01
Brief Title:
Percussion Palm Cup Safety and Usability in Infants and Children With Cystic Fibrosis
Sponsor:
West Park Healthcare Centre
Organization:
West Park Healthcare Centre
Study Overview
Official Title:
Percussion Palm Cup Safety and Usability of Newly Designed Products in Infants and Children With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPC
Brief Summary:
Cystic Fibrosis is the most prevalent fatal genetic disease affecting Canadian children and it primarily characterized by a thickening of pulmonary secretions and impaired mucociliary clearance Chest physiotherapy has been widely used as a standard treatment for sputum mobilization and clearance for individuals with CF Percussion is one such technique of chest physiotherapy for loosening trapped music within the lungs and can be completed manually or facilitated with a percussion cup Unfortunately the exclusive Canadian supplier for the widely use percussor cup has stopped distributing the cups leaving many hospitals and therapy clinics searching for alternatives to continue airway clearance treatment The goal of this project is to compare alternative palm cup solutions to the standard and recommend safe alternatives that caregivers can have easy access to
Detailed Description:
An average adult hand may be too large and taxing for percussion on infants and children therefore percussor palm cups facilitate caregivers and physiotherapists The palm cup mimics the air compressed through cupped hands and can be used in conjunction with other physiotherapy techniques and has been shown to have a positive impact on symptoms Engineers at McMaster University have developed 3D-printed prototypes to use with percussor cups that are made with material similar in consistency and flexibility to the no longer manufactured standard cup These cups will be tested in infants and children with cystic fibrosis recruited from the Cystic Fibrosis Clinic at McMaster Childrens Hospital in Hamilton Ontario
Patientsguardianscaregivers will be given 3 percussor palm cups to use over the course of 6 days one standard cup and two 3D-printed Each cup will be trialed for 2 days allowing for equal time dedicated to each Demographic data and characteristics will be collected at baseline and measures of safety and usability will be completed at the end of the week of use Overall satisfaction will be recorded at the end of the questionnaire Participants will be asked to rate percussion palm cups from least preferred to most preferred and an open-ended question to explain their reasoning on the experience
Thus the purpose of the study is to examine the safety usability and user experience of newly designed percussion palm cups using 3-D printing The results of this study will have important implication to the management of infants and children with CF given the percussion palm cup shortage
Patientsguardianscaregivers will be given 3 percussor palm cups to use over the course of 6 days one standard cup and two 3D-printed Each cup will be trialed for 2 days allowing for equal time dedicated to each Demographic data and characteristics will be collected at baseline and measures of safety and usability will be completed at the end of the week of use Overall satisfaction will be recorded at the end of the questionnaire Participants will be asked to rate percussion palm cups from least preferred to most preferred and an open-ended question to explain their reasoning on the experience
Thus the purpose of the study is to examine the safety usability and user experience of newly designed percussion palm cups using 3-D printing The results of this study will have important implication to the management of infants and children with CF given the percussion palm cup shortage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None