NCT04059107

Prosthetic Device in Children With Upper Congenital Limb Deficiency

Evaluation of 3D Printed Myoelectric Prosthetics in Children With Upper Congenital Limb Deficiency

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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 year at the following intervals: baseline, 3 month, 6 month, 12 months. In following the protocol, each study visit will use the Assessment of Capacity for Myoelectric Control (ACMC) functional testing. The study participants will also complete several parent-child reported health related quality of life and musculoskeletal questionnaires. Specifically, the Pediatric Outcomes Data Collection Instrument (PODCI), the Pediatric Quality of Life Inventory (PedsQL), and the Children's Hand-Use Experience Questionnaire (CHEQ) will be used to measure efficacy of the myoelectric devices..

Conditions

• Upper Limb Deformities, Congenital

Interventions

Type	Name	Description
DEVICE	3D Printed Myoelectric Prosthetic Device	3D Printed Myoelectric Prosthetic Device

Timeline

• Start date: 2019-07-03
• Primary completion: 2021-09-30
• Completion: 2021-12-31
• First posted: 2019-08-16
• Last updated: 2021-03-10

Locations

2 sites across 1 country: United States