Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Safety and user questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The cups will be numbered, not identified by manufactured cup or 3D printed.
入排标准
- 年龄范围
- 1 Month 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Safety and user questionnaire
时间窗: Through study completion, average 1 year
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.
Usability using the Pictorial Single-Item Usability Scale (PSIUS)
时间窗: Through study completion, average 1 year
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.
次要结局
- Overall satisfaction questionnaire(Through study completion, average 1 year)
- Quebec User Evaluation Utility Questionnaire (QUEST)(Through study completion, average 1 year)
研究者
Dina Brooks
Principal Investigator
West Park Healthcare Centre