Study Results
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View full resultsBasic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2018-09-21
2018-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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, patient mobility, powered
Pediatric mobility device
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, patient mobility, powered
Pediatric mobility device
Interventions
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Device, patient mobility, powered
Pediatric mobility device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
36 Months
ALL
No
Sponsors
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Permobil, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karin Leire
Role: STUDY_DIRECTOR
Permobil Group
Locations
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Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Oregon State University
Corvallis, Oregon, United States
Belmont University
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Per2018P04
Identifier Type: -
Identifier Source: org_study_id
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