Prosthetic Device in Children With Upper Congenital Limb Deficiency

Upper Limb Deformities, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04059107
• Other study ID #: OHSU IRB17087
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Upper Extremity Deformities, Congenital
• Upper Limb Deformities, Congenital

Intervention

Device:
• 3D Printed Myoelectric Prosthetic Device
3D Printed Myoelectric Prosthetic Device

Locations

Country	Name	City	State
United States	The University of Central Florida	Orlando	Florida
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	Limbitless Solutions, University of Central Florida

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

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