Clinical trial NCT03714256: Human Factor Validation of Pediatric Mobility Device
Official title: Human Factor Validation of Pediatric Mobility Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disability Physical
Keywords: Pediatric
Lead sponsor: Permobil, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-22
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
city: Nashville
country: United States
facility: Belmont University
state: Tennessee
Study officials:
affiliation: Permobil Group
name: Karin Leire
role: STUDY_DIRECTOR
References: