Prosthetic Device in Children With Upper Congenital Limb Deficiency

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Upper Limb Deformities, Congenital
• Intervention / Treatment: Device: 3D Printed Myoelectric Prosthetic Device

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • The University of Central Florida
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prosthetic Device; 3D Printed Myoelectric Prosthetic Device	Device: 3D Printed Myoelectric Prosthetic Device; 3D Printed Myoelectric Prosthetic Device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: University of Central Florida; Limbitless Solutions
• Investigators: Principal Investigator: Albert Chi, MD, Oregon Health and Science University

Publications and helpful links

General Publications

• Canfield MA, Honein MA, Yuskiv N, Xing J, Mai CT, Collins JS, Devine O, Petrini J, Ramadhani TA, Hobbs CA, Kirby RS. National estimates and race/ethnic-specific variation of selected birth defects in the United States, 1999-2001. Birth Defects Res A Clin Mol Teratol. 2006 Nov;76(11):747-56. doi: 10.1002/bdra.20294.
• Blough DK, Hubbard S, McFarland LV, Smith DG, Gambel JM, Reiber GE. Prosthetic cost projections for servicemembers with major limb loss from Vietnam and OIF/OEF. J Rehabil Res Dev. 2010;47(4):387-402. doi: 10.1682/jrrd.2009.04.0037.

Helpful Links

• Facts about Upper and Lower Limb Reduction Defects
• Limbitless Solutions

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Upper Extremity Deformities, Congenital
• Other Study ID Numbers: OHSU IRB17087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No