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Assessment of Neural and Motor Performance

NCT04241588 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-09-03

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. With the use of low-cost 3D printed prosthetics, the purpose of this study is to examine the assessment of primary motor cortex activation and the representation of gray and white matter in a child with congenital limb loss. This will be accomplished by cross-examining results from fNIR and Anatomical Magnetic Resonance Imaging (MRI). The proposed research uses anatomical MRI to test if children with unilateral congenital partial hand reductions demonstrate less gray and white matter in the motor representation zones. Moreover, the proposed research will focus on an assessment of motor performance using continuous and discrete tasks with a robotic manipulandum. Assessment of motor performance and neural networking are critical to increasing our limited knowledge of how the child increases the number of motor repertoires.

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 the 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. The device will be given to participants so that they may practice using the device at home.

OTHER

Control

A 3D printed hand with be fitted to simulate a prosthesis.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Jorge M Zuniga, PhD · University of Nebraska

Eligibility

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

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2022-11-22
Completion
2022-11-22
FDA Device
Yes

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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 NCT04241588 on ClinicalTrials.gov