Human Factor Validation of Pediatric Mobility Device

Study Overview
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Brief Summary
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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
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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.

Official Title
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Human Factor Validation of Pediatric Mobility Device

Conditions
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Disability Physical

Intervention / Treatment
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* Device: Device, patient mobility, powered


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children 6-17 months<br>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. | Device: Device, patient mobility, powered<br>* Pediatric mobility device<br>|
| Experimental: Children 18 - 36 months<br>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. | Device: Device, patient mobility, powered<br>* Pediatric mobility device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric