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

West Park Healthcare Centre

Status: Completed

Conditions: Cystic Fibrosis in Children

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04835376

13112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 1 month to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 3 patient groups

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

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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