Percussion Palm Cup: Safety and Usability in Infants and Children With Cystic Fibrosis

NCT04835376 | Completed

• 1 other identifier: 13112
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis in Children

Keywords

Cystic Fibrosis; Chest Physiotherapy; Percussion Palm Cup; Children and Infants

Outcome Measures

Primary Outcomes (2)

• Safety and user questionnaire

  Participants and families will be asked to report any adverse effects of the use of the PCC. These could include erythema of the skin, bruising or general discomfort using a 5-point Likert scale (1 = very disatisfied, 5 = very satisfied) and open-ended questions. A higher value on the Likert scale indicates a better outcome as the participant identifies that they were satisfied when using the cup. This will also be used to compare satisfaction between cups.

  Through study completion, average 1 year

• Usability using the Pictorial Single-Item Usability Scale (PSIUS)

  The Pictorial Single-Item Usability Scale (PSIUS) is an instrument used to measure perceived usability and satisfaction of each cup. This scale concludes three main visual elements that evaluate satisfaction and emotions experience while using a system or product. It uses visual images of disatisfaction to satisfaction, following a 9-point scale (-4 = very disatisfied, 4 = very satisfied). A higher number indicates a better experience when using the cup. This pictorial single-item scale will be used within our questionnaire to assess the overall rating of satisfaction and usability when using the Percussion Palm Cups.

  Through study completion, average 1 year

Secondary Outcomes (2)

• Quebec User Evaluation Utility Questionnaire (QUEST)

  Through study completion, average 1 year

• Overall satisfaction questionnaire

  Through study completion, average 1 year

Study Arms (3)

Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 1

EXPERIMENTAL

The standard percussor palm cups are made out of a soft vinyl material molded into shape. The outer diameter of the infant palm cup is 1-3/4 inches and there is a 1-inch diameter pocket inside this product similar to a suction cup.

Device: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis

Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 2

EXPERIMENTAL

This product was developed by MMRI personnel using a small custom 3D printed plastic handle and a 0.93-inch, single bellow, Buna-N rubber suction cup. The handle was made on the MMRI's 3D printer using ABS plastic and the suction cup was sourced from McMaster Carr (#5427A106). The handle is made up of three pieces; top, base and a pin that is designed to fix the top, base and suction cup to each other. There is a small hole through the pin which helps relieve some of the pressure that builds in the suction cup during use. It is not shown in the image to the right, but the handle will be coated in Plasti Dip for added user comfort.

Device: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis

Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 3

EXPERIMENTAL

This product was developed by MMRI personnel using a large custom 3D printed plastic handle and a 0.93-inch, single bellow, Buna-N rubber suction cup. The handle was made on the MMRI's 3D printer using ABS plastic and the suction cup was sourced from McMaster Carr (#5427A106). The handle is made up of three pieces; top, base and a pin that is designed to fix the top, base and suction cup to each other. There is a small hole through the pin which helps relieve some of the pressure that builds in the suction cup during use. It is not shown in the image to the right, but the handle will be coated in Plasti Dip for added user comfort.

Device: Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis

Interventions

Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis DEVICE

Patients/guardians/caregivers will be given 3 percussor palm cups to use over the course of 6 days. Each cup will be trialed for 2 days, allowing for equal time dedicated to each.

Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 1; Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 2; Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 3

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Park Healthcare Centre: lead

Study Sites (1)

McMaster Children's Hospital Cystic Fibrosis Clinic

Hamilton, Ontario, L8S 2A5, Canada

Location

Related Publications (15)

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MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The cups will be numbered, not identified by manufactured cup or 3D printed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized crossover intervention

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 8, 2021
• Study Start: May 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)