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Prosthetic Device in Children With Upper Congenital Limb Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04059107
Recruitment Status : Enrolling by invitation
First Posted : August 16, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborators:
Limbitless Solutions
University of Central Florida
Information provided by (Responsible Party):
Albert Chi, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Upper Limb Deformities, Congenital Device: 3D Printed Myoelectric Prosthetic Device Not Applicable

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..

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of 3D Printed Myoelectric Prosthetics in Children With Upper Congenital Limb Deficiency
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Prosthetic Device
3D Printed Myoelectric Prosthetic Device
Device: 3D Printed Myoelectric Prosthetic Device
3D Printed Myoelectric Prosthetic Device




Primary Outcome Measures :
  1. Primary Safety Endpoint - Measuring safety of the device through adverse event reporting. [ Time Frame: 12 months ]
    The safety of the device will be measured through parental reporting and recorded observations of adverse events.

  2. Children's experiences of using the myoelectric device while performing bi-manual tasks as assessed using a self-report questionnaire. [ Time Frame: 12 months ]
    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.

  3. Detects expected change in a person's ability to to do various functions while performing a specific task and scoring their motions. [ Time Frame: 12 months ]
    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).

  4. This self-report or parent-report tool is used to assess musculoskeletal health of the myoelectric device user. [ Time Frame: 12 months ]
    This assessment contains six scales Upper Extremity Physical Function; Mobility/Transfers; Sports/Physical Function; Pain/Comfort; Happiness; and Global Function.

  5. A self-report and parent-report sectional approach to measuring health-related quality of life. [ Time Frame: 12 months ]
    This assessment uses four generic core scales including: physical health, emotional functioning, social functioning, and school functioning.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059107


Locations
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United States, Florida
The University of Central Florida
Orlando, Florida, United States, 32816
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Limbitless Solutions
University of Central Florida
Investigators
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Principal Investigator: Albert Chi, MD Oregon Health and Science University
Additional Information:
Publications:
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Responsible Party: Albert Chi, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT04059107    
Other Study ID Numbers: OHSU IRB17087
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Limb Deformities, Congenital
Upper Extremity Deformities, Congenital
Congenital Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases