Prosthetic Device in Children With Upper Congenital Limb Deficiency

Study Overview
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Brief Summary
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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
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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..

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

Conditions
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Upper Limb Deformities, Congenital

Intervention / Treatment
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* Device: 3D Printed Myoelectric Prosthetic Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prosthetic Device<br>3D Printed Myoelectric Prosthetic Device | Device: 3D Printed Myoelectric Prosthetic Device<br>* 3D Printed Myoelectric Prosthetic Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint - Measuring safety of the device through adverse event reporting. | The safety of the device will be measured through parental reporting and recorded observations of adverse events. | 12 months | 
| Children's experiences of using the myoelectric device while performing bi-manual tasks as assessed using a self-report questionnaire. | 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. | 12 months | 
| Detects expected change in a person's ability to to do various functions while performing a specific task and scoring their motions. | 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). | 12 months | 
| This self-report or parent-report tool is used to assess musculoskeletal health of the myoelectric device user. | This assessment contains six scales Upper Extremity Physical Function; Mobility/Transfers; Sports/Physical Function; Pain/Comfort; Happiness; and Global Function. | 12 months | 
| A self-report and parent-report sectional approach to measuring health-related quality of life. | This assessment uses four generic core scales including: physical health, emotional functioning, social functioning, and school functioning. | 12 months |