NCT04059107|UnknownDMC
Prosthetic Device in Children With Upper Congenital Limb Deficiency
Evaluation of 3D Printed Myoelectric Prosthetics in Children With Upper Congenital Limb Deficiency
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Evaluation of 3D Printed Myoelectric Prosthetics in Children With Upper Congenital Limb Deficiency
Sponsor study identifier
interventional
20
1 country
2
Study Start
July 3, 2019
Actual (reported)Primary Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2, 2019
Actual (reported)July 3, 2019
Actual (reported)August 16, 2019
Actual (reported)September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
3D Printed Myoelectric Prosthetic Device
3D Printed Myoelectric Prosthetic Device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The University of Central Florida
Orlando, Florida, 32816, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
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.
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.
Albert Chi, MD
Oregon Health and Science University
First Submitted
July 2, 2019
First Posted
August 16, 2019
Study Start
July 3, 2019
Actual (reported)Primary Completion
September 30, 2021
Estimated (date passed)SoftHand Comparison Study
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 10, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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