- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03714256
Human Factor Validation of Pediatric Mobility Device
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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. |
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. |
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
Sponsor
Investigators
- Study Director: Karin Leire, Permobil Group
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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