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The Influence of 3D Printed Prostheses on Neural Activation Patterns

NCT04110730 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

  • Amniotic Band Syndrome
  • Upper Extremity Deformities, Congenital

Interventions

DEVICE

3D 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.

BEHAVIORAL

Home 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.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Jorge M Zuniga, PhD · University of Nebraska

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04110730 on ClinicalTrials.gov