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 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
33
Pediatric mobility device
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Oregon State University
Corvallis, Oregon, United States
Belmont University
Nashville, Tennessee, United States
Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling
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
Time frame: One day
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