RecruitingNot ApplicableNCT04110730

The Influence of 3D Printed Prostheses on Neural Activation Patterns

The Influence of 3D Printed Prostheses on Neural Activation Patterns of the Primary Motor Cortex in Children With Unilateral Congenital Upper-limb Reductions


Sponsor

University of Nebraska

Enrollment

40 participants

Start Date

Jan 10, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The neural basis underlying motor performance in children using a prosthesis has been severely understudied resulting in minimal empirical evidence. The use of functional near-infrared spectroscopy (fNIRS) in conjunction with customized and visually appealing 3D printed prostheses would provide the unique opportunity to quantitatively assess the influence of upper-limb prostheses in the neural activation patterns of the primary motor cortex and motor performance of children. This information would increase the investigators limited knowledge of how prosthesis usage influences the primary motor cortex of growing children and use this information to develop rehabilitation programs aimed at reducing prosthesis rejection and abandonment.


Eligibility

Min Age: 3 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring how wearing a 3D-printed prosthetic or assistive device for the hand, arm, or shoulder affects brain activity and nerve activation patterns in children who are missing limbs or have upper limb differences. Researchers use brain imaging techniques to understand how these devices change the way the nervous system responds, which could help design better prosthetics in the future. You may be eligible if: - You are between 3 and 18 years old - You are missing fingers, a hand, an arm, or have dysfunction of the upper limb(s) You may NOT be eligible if: - You are outside the age range of 3 to 18 years - You had an upper extremity injury within the past month - You have a medical condition that makes it unsafe to wear a prosthetic or assistive device, such as skin abrasions or musculoskeletal injuries in the upper limbs Talk to your child's pediatric orthopedic or rehabilitation specialist if your child has an upper limb difference or amputation and you want to understand how prosthetic devices might benefit their brain development and function.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE3D Printed Upper-limb Prosthesis

The fingers and thumb were made of polylactic acid polymer manufactured using industrial 3D printers. The palm, socket, forearm brace, and leveraging structure were made of polylactic acid which has properties similar to thermoplastic that facilitate post manufacturing adjustments. Elastic cords placed inside the dorsal aspect of the fingers provided passive finger extension. Finger flexion was driven by non-elastic cords along the palmar surface of each finger and was activated through 20-30 degrees of wrist or elbow flexion.

BEHAVIORALHome Intervention

An occupational therapy student will perform 3 home visits a week and will direct a training protocol that consists of completing three trials of a series of 6 block building activities (i.e., block-stacking) for each hand separated by 30 seconds of rest (a total of 18 block building activities per hand). The block stacking activity consists in building a 4 block train, 3 cube bridge, 4 block wall, 3 block tower, 6 block steps, and 6 block pyramid. All subjects including the control group will perform the same home training protocol.


Locations(1)

University of Nebraska at Omaha

Omaha, Nebraska, United States

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NCT04110730


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