Prosthetic Device in Children With Upper Congenital Limb Deficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-03

Study Completion Date

2021-12-31

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.

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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..

Conditions

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Upper Limb Deformities, Congenital

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prosthetic Device

3D Printed Myoelectric Prosthetic Device

Group Type EXPERIMENTAL

3D Printed Myoelectric Prosthetic Device

Intervention Type DEVICE

3D Printed Myoelectric Prosthetic Device

Interventions

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3D Printed Myoelectric Prosthetic Device

Intervention Type DEVICE

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No