Prosthetic Device in Children With Upper Congenital Limb Deficiency

Not Applicable

• Conditions: Upper Limb Deformities, Congenital
• Interventions: Device: 3D Printed Myoelectric Prosthetic Device

• Registration Number: NCT04059107
• Lead Sponsor: Oregon Health and Science University

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 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..

Study Timeline

• Study First Submitted: 2019-07-02
• Study Start: 2019-07-03
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prosthetic Device	3D Printed Myoelectric Prosthetic Device	3D Printed Myoelectric Prosthetic Device

Primary Outcome Measures

Name	Time	Method
A self-report and parent-report sectional approach to measuring health-related quality of life.	12 months	This assessment uses four generic core scales including: physical health, emotional functioning, social functioning, and school functioning.
Primary Safety Endpoint - Measuring safety of the device through adverse event reporting.	12 months	The safety of the device will be measured through parental reporting and recorded observations of adverse events.
Children's experiences of using the myoelectric device while performing bi-manual tasks as assessed using a self-report questionnaire.	12 months	This assessment will measure the ability of the user to perform day-to-day tasks on three scales: grasp, performance time, and level of frustration.
Detects expected change in a person's ability to to do various functions while performing a specific task and scoring their motions.	12 months	This assessment will evaluate the ability of the myoelectric device use on functions that involve griping, holding, releasing, and coordinating between limbs using the Assessment of Capacity for Myoelectric Control (ACMC).
This self-report or parent-report tool is used to assess musculoskeletal health of the myoelectric device user.	12 months	This assessment contains six scales Upper Extremity Physical Function; Mobility/Transfers; Sports/Physical Function; Pain/Comfort; Happiness; and Global Function.

Trial Locations

Locations (2)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

The University of Central Florida; 🇺🇸 Orlando, Florida, United States