Percussion Palm Cup: Safety and Usability in Infants and Children With Cystic Fibrosis
Condition: Cystic Fibrosis in Children
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

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.
    

Intervention name(s): Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover intervention
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Chest Physiotherapy; Percussion Palm Cup; Children and Infants