Prosthetic Device in Children With Upper Congenital Limb Deficiency

Oregon Health & Science University (OHSU)

Status: Unknown

Conditions: Upper Limb Deformities, Congenital

Treatments: Device: 3D Printed Myoelectric Prosthetic Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04059107

OHSU IRB17087

Details and patient eligibility

About

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.

Full 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..

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Prosthetic Device

Experimental group

Description:

3D Printed Myoelectric Prosthetic Device

Treatment:

Device: 3D Printed Myoelectric Prosthetic Device