Human Factor Validation of Pediatric Mobility Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling
研究概览
简要总结
The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users.
详细描述
The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users. The human factors validation study will be conducted in children with mobility impairments as categorised by Hays (1987) in the age range of 6 months to 36 months under realistic use conditions.The study is an open label, un-blinded, non-randomized study which consists of one visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary users:
- •Informed consent signed by parents or guardian
- •Aged 6-36 months
- •Unable to mobilize independently for exploratory play and peer interaction, as categorized by Hays (1987)
- •Adequate trunk and head control to remain upright in the device, including regain head control
- •Adequate hand/ arm (distal) control to reach for objects in front of them
- •Secondary users:
- •Signed informed consent
- •Physiotherapist/Occupational Therapist or parent/guardian of the child included in the test
排除标准
- •Primary users:
- •Weight >16 kg/35 Ibs
- •Length >100 cm/39 In
- •Children that lack head control in such a severe manner that they cannot regain control if it is lost
- •Children who do not show awareness of or respond to toys, objects, sounds and/or people in their environment
- •Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test.
- •Secondary users:
- •Hearing/vision loss or limited cognitive skills impacting the ability to take instructions and perform the tasks of the test
- •Ability to understand oral and written English as product labelling will in this Human Factor validation test only be available in English
- •Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test
结局指标
主要结局
Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling
时间窗: One day
The tasks in this Human factors validation test, that will be performed by the users are: charge battery and disconnect it, adjust seat and table height, adjust the speed, place the child in device, adjust cushion and other support. The summary of identified errors, captured through observation and interview, will be counted and define the primary outcome
次要结局
未报告次要终点