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Prosthesis

3D Printed Prostheses for Upper Extremity Deformities

N/A

Recruiting

Led By Jorge M Zuniga, PhD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 3-18 years

Any dysfunction of the upper limbs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline of movement duration at 8 weeks.

Awards & highlights

Study Summary

This trial will use fNIRS to study how a prosthesis affects the primary motor cortex of children, and whether this information can be used to improve rehabilitation programs for children using prostheses.

Who is the study for?

This trial is for children and teens aged 3-18 with missing digits or parts of their arm due to conditions like Amniotic Band Syndrome. They should be able to wear a prosthetic but can't join if they have recent injuries, skin issues, or other medical problems that make using a prosthetic difficult.Check my eligibility

What is being tested?

The study tests how cool-looking, custom-made 3D printed upper-limb prostheses affect brain activity related to movement in kids. Researchers will use special imaging (fNIRS) to see changes in the motor cortex when these prostheses are used.See study design

What are the potential side effects?

Since this trial involves non-invasive home interventions and wearing a prosthesis, side effects might include discomfort from wearing the device or skin irritation at contact points.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 18 years old.

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I have problems with the movement or function of my arms or hands.

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I am missing a digit, hand, arm, or shoulder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline of mean values of brain hemodynamic responses at 8 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline of mean values of brain hemodynamic responses at 8 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline of mean values of brain hemodynamic responses at 8 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change of hemispheric dominance

Change of mean values of brain hemodynamic responses

Change of movement duration

+1 more

Secondary outcome measures

Satisfaction assessed by the Orthotics Prosthetics Users' Survey (OPUS).

Satisfaction assessed by the Project-Prosthesis Satisfaction Inventory (CAPP-PSI).

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 3D Prostheses UsersExperimental Treatment2 Interventions

Children with unilateral congenital upper-limb reductions

Group II: Typically Developing ChildrenActive Control1 Intervention

Age- and sex-matched control group of typically developing children.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home Intervention

2022

N/A

~110

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

538 Previous Clinical Trials

1,144,514 Total Patients Enrolled

Jorge M Zuniga, PhDPrincipal InvestigatorUniversity of Nebraska

1 Previous Clinical Trials

Media Library

3D Printed Upper-limb Prosthesis (Prosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT04110730 — N/A

Congenital Upper Extremity Deformities Research Study Groups: 3D Prostheses Users, Typically Developing Children

Congenital Upper Extremity Deformities Clinical Trial 2023: 3D Printed Upper-limb Prosthesis Highlights & Side Effects. Trial Name: NCT04110730 — N/A

3D Printed Upper-limb Prosthesis (Prosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04110730 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been admitted to this clinical trial thus far?

"Affirmative. Clinicaltrials.gov's information indicates that this study, initially posted on October 1st 2020, is actively searching for 40 participants at one location."

Answered by AI

Is the age cutoff for participation in this medical research confined to adults aged 45 or younger?

"This clinical trial is looking for participants between the ages of 3 and 18."

Answered by AI

Is it possible for me to sign up for this experiment?

"The researchers of this trial are seeking 40 participants who have amniotic bands and range from 3 to 18 years old. In order for a patient to be considered, they must display upper limb dysfunction or lack any digits in the hand, arm, shoulder area."

Answered by AI

Are investigators registering new participants for this study?

"According to clinicaltrials.gov, this investigation is currently seeking participants; it was first uploaded on 10th January 2020 and recently edited on the 4th November 2022."

Answered by AI

Recent research and studies

Journal of NeuroEngineering and RehabilitationJournal

Brain Lateralization in Children with Upper-limb Reduction Deficiency

Zuniga, Jorge M., James E. Pierce, Christopher Copeland, Claudia Cortes-Reyes, David Salazar, YingYing Wang, K. M. Arun, and Theodore Huppert. 2021. “Brain Lateralization in Children with Upper-limb Reduction Deficiency”. Journal of Neuroengineering and Rehabilitation. Springer Science and Business Media LLC. doi:10.1186/s12984-020-00803-1.

clinicaltrials.govStudy

The Influence of 3D Printed Prostheses on Neural Activation Patterns

Jorge M. Zuniga 2020. "The Influence of 3D Printed Prostheses on Neural Activation Patterns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04110730.