Human Factor Validation of Pediatric Mobility Device

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.

Inclusion criteria

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

Exclusion criteria

• 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