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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children With Cystic Fibrosis

Conditions
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Cystic Fibrosis in Children

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized crossover intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 1<br>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<br>* 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.<br>|
| Experimental: Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 2<br>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<br>* 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.<br>|
| Experimental: Randomized Crossover: Percussion Palm Cup Safety and Usability - Cup 3<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quebec User Evaluation Utility Questionnaire (QUEST) | The Quebec User Evaluation Utility Questionnaire (QUEST) is designed to evaluate user satisfaction and dissatisfaction with assistive devices. It is the most commonly used standardized instrument for measuring user satisfaction with a broad range of assistive technology devices. The revised QUEST 2.0 version includes a 12-item structure, with each item scored using a 5-point satisfaction scale (1= not satisfied at all, 5 = very satisfied). Additionally, the user is asked to comment on the source of their dissatisfaction or satisfaction on each item. We will use the applicable items (8 in total) Comfort, Dimensions, Simplicity of Use, Effectiveness, Durability, Adjustments, Safety, and Weight. | Through study completion, average 1 year | 
| Overall satisfaction questionnaire | Overall satisfaction and user experience will be recorded. Participants will be asked to discuss any concerns, discomfort when using the palm cup and rate percussion palm cups from least preferred to most preferred with open-ended questions to explain their reasoning with no minimum or maximum values. Each cup will be ranked as either first, second, and third choice (cup #1,2,3 = first, second or third choice in ranking). First choice indicates the best overall experience, last choice indicates the worst overall expereince or least preferred. | Through study completion, average 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Chest Physiotherapy, Percussion Palm Cup, Children and Infants