Clinical trial NCT04835376: Percussion Palm Cup: Safety and Usability in Infants and Children With Cystic Fibrosis
Official title: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis in Children
Keywords: Cystic Fibrosis
Chest Physiotherapy
Percussion Palm Cup
Children and Infants
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover intervention
Primary purpose: TREATMENT

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 alternative(s) 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 Children's Hospital in Hamilton, Ontario.

Patients/guardians/caregivers 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.

Eligibility criteria: Inclusion Criteria:

* Infants and children with CF under the age of 6 and their parent/guardian/caregiver to perform chest percussions using percussor palm cups.
* Participants must currently require regular chest physiotherapy.

Exclusion Criteria:

* A comorbid condition that is a contraindication for the use of percussor palm cups.
* Inability of parent/guardian/caregiver to complete written questionnaires due to visual or cognitive impairment.

Primary outcomes:
measure: Safety and user questionnaire
timeFrame: Through study completion, average 1 year
measure: Usability using the Pictorial Single-Item Usability Scale (PSIUS)
timeFrame: Through study completion, average 1 year
Secondary outcomes:
measure: Quebec User Evaluation Utility Questionnaire (QUEST)
timeFrame: Through study completion, average 1 year
measure: Overall satisfaction questionnaire
timeFrame: Through study completion, average 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital Cystic Fibrosis Clinic
state: Ontario
Study officials:
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