Human Factor Validation of Pediatric Mobility Device
Completed · Not applicable
Conditions studied: Disability Physical
In brief
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.
Key facts
- Study ID
- NCT03714256
- Run by
- Permobil, Inc.
- People needed
- 33
- Starts
- 2018-09-21
- Expected to finish
- 2018-11-19
- Last updated by the study team
- 2021-01-14
Who can join
Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
- Oregon State University — Corvallis, Oregon, United States
- Belmont University — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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