Human Factor Validation of Pediatric Mobility Device
- Conditions
- Disability Physical
- Interventions
- Device: Device, patient mobility, powered
- Registration Number
- NCT03714256
- Lead Sponsor
- Permobil, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Children 18 - 36 months Device, patient mobility, powered Device, patient mobility, powered: Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion. Children 6-17 months Device, patient mobility, powered Device, patient mobility, powered: Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.
- Primary Outcome Measures
Name Time Method Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Oregon State University
🇺🇸Corvallis, Oregon, United States
Belmont University
🇺🇸Nashville, Tennessee, United States