Human Factor Validation of Pediatric Mobility Device

January 8, 2021 updated by: Permobil, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Childrens Hospital Medical Center
    • Oregon
      • Corvallis, Oregon, United States, 97331
        • Oregon State University
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Belmont University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Children 6-17 months

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
Pediatric mobility device
EXPERIMENTAL: Children 18 - 36 months

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
Pediatric mobility device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling
Time Frame: One day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Permobil, Inc.

Investigators

  • Study Director: Karin Leire, Permobil Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 21, 2018

Primary Completion (ACTUAL)

November 19, 2018

Study Completion (ACTUAL)

November 19, 2018

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (ACTUAL)

October 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Per2018P04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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