Status:
UNKNOWN
Prosthetic Device in Children With Upper Congenital Limb Deficiency
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Limbitless Solutions
University of Central Florida
Conditions:
Upper Limb Deformities, Congenital
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
This is a study being performed to evaluate the safety and effectiveness of 3D printed myoelectric prosthetic devices in children with a congenital upper limb deficiency.
Detailed Description
The purpose of this study is to learn more about whether myoelectric prosthetic devices would be beneficial and useful for children. The study protocol specifies 4 study visits over the course of a ye...
Eligibility Criteria
Inclusion
- Children between the ages of 6 to 17 with congenital/infant upper limb deficiency identified by Limbitless Solutions will be referred to OHSU for evaluation and selection.
- All approved and consented subjects will receive a Limbitless 3D printed myoelectric device as delivered by established protocol.
- Preference will be given to children with long term previous experience with Limbitless Solutions' bionic systems.
Exclusion
- Non English-speaking children and families. Due to the entirely volunteer nature of this project, the investigators are unable to hire appropriate translation services or create translated forms and surveys in other languages currently.
- Shoulder or wrist disarticulation will be excluded.
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04059107
Start Date
July 3 2019
End Date
December 31 2021
Last Update
March 10 2021
Active Locations (2)
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1
The University of Central Florida
Orlando, Florida, United States, 32816
2
Oregon Health & Science University
Portland, Oregon, United States, 97239