Human Factor Validation of Pediatric Mobility Device

Disability Physical Clinical Trial

Official title:

Human Factor Validation of Pediatric Mobility Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714256
• Other study ID #: Per2018P04
• Status: Completed
• Phase: N/A
• Start date: September 21, 2018
• Est. completion date: November 19, 2018

Study information

• Verified date: January 2021
• Source: Permobil, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Disability Physical

Intervention

Device:
• Device, patient mobility, powered
Pediatric mobility device

Locations

Country	Name	City	State
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio
United States	Oregon State University	Corvallis	Oregon
United States	Belmont University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Permobil, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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