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Prosthetic Device in Children With Upper Congenital Limb Deficiency

Primary Purpose

Upper Limb Deformities, Congenital

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D Printed Myoelectric Prosthetic Device
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Limb Deformities, Congenital

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • The University of Central Florida
  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prosthetic Device

Arm Description

3D Printed Myoelectric Prosthetic Device

Outcomes

Primary Outcome Measures

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.
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.
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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2019
Last Updated
March 9, 2021
Sponsor
Oregon Health and Science University
Collaborators
Limbitless Solutions, University of Central Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04059107
Brief Title
Prosthetic Device in Children With Upper Congenital Limb Deficiency
Official Title
Evaluation of 3D Printed Myoelectric Prosthetics in Children With Upper Congenital Limb Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Limbitless Solutions, University of Central Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Limb Deformities, Congenital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prosthetic Device
Arm Type
Experimental
Arm Description
3D Printed Myoelectric Prosthetic Device
Intervention Type
Device
Intervention Name(s)
3D Printed Myoelectric Prosthetic Device
Intervention Description
3D Printed Myoelectric Prosthetic Device
Primary Outcome Measure Information:
Title
Primary Safety Endpoint - Measuring safety of the device through adverse event reporting.
Description
The safety of the device will be measured through parental reporting and recorded observations of adverse events.
Time Frame
12 months
Title
Children's experiences of using the myoelectric device while performing bi-manual tasks as assessed using a self-report questionnaire.
Description
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.
Time Frame
12 months
Title
Detects expected change in a person's ability to to do various functions while performing a specific task and scoring their motions.
Description
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).
Time Frame
12 months
Title
This self-report or parent-report tool is used to assess musculoskeletal health of the myoelectric device user.
Description
This assessment contains six scales Upper Extremity Physical Function; Mobility/Transfers; Sports/Physical Function; Pain/Comfort; Happiness; and Global Function.
Time Frame
12 months
Title
A self-report and parent-report sectional approach to measuring health-related quality of life.
Description
This assessment uses four generic core scales including: physical health, emotional functioning, social functioning, and school functioning.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Chi, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17051527
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. doi: 10.1002/bdra.20294.
Results Reference
background
PubMed Identifier
20803406
Citation
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.
Results Reference
background
Links:
URL
https://www.cdc.gov/ncbddd/birthdefects/ul-limbreductiondefects.html
Description
Facts about Upper and Lower Limb Reduction Defects
URL
http://limbitless-solutions.org/about-us/
Description
Limbitless Solutions

Learn more about this trial

Prosthetic Device in Children With Upper Congenital Limb Deficiency

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