Prosthetic Device in Children With Upper Congenital Limb Deficiency

NCT04059107 | Unknown DMC

• 1 other identifier: OHSU IRB17087
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Upper Limb Deformities, Congenital

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Prosthetic Device

EXPERIMENTAL

3D Printed Myoelectric Prosthetic Device

Device: 3D Printed Myoelectric Prosthetic Device

Interventions

3D Printed Myoelectric Prosthetic Device DEVICE

3D Printed Myoelectric Prosthetic Device

Prosthetic Device

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Limbitless Solutions: collaborator
• University of Central Florida: collaborator

Study Sites (2)

The University of Central Florida

Orlando, Florida, 32816, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• 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.

  PMID: 17051527 BACKGROUND

• 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.

  PMID: 20803406 BACKGROUND

Related Links

• Limbitless Solutions

MeSH Terms

Conditions

Upper Extremity Deformities, Congenital

Condition Hierarchy (Ancestors)

Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Albert Chi, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: August 16, 2019
• Study Start: July 3, 2019
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)