3D Printed Upper-limb Prosthesis for Congenital Upper Extremity Deformities

University of Nebraska at Omaha, Omaha, NE
Congenital Upper Extremity Deformities+1 More Conditions3D Printed Upper-limb Prosthesis - Device
3 - 18
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Congenital Upper Extremity Deformities
  • Amniotic Band Syndrome

Treatment Effectiveness

Study Objectives

4 Primary · 2 Secondary · Reporting Duration: Change from baseline of hemispheric dominance at 8 weeks.

Week 8
Change of hemispheric dominance
Week 8
Change of mean values of brain hemodynamic responses
Week 8
Change of movement duration
Week 8
Change of synchrony of hand movement
after 8 weeks.
Satisfaction assessed by the Orthotics Prosthetics Users' Survey (OPUS).
Satisfaction assessed by the Project-Prosthesis Satisfaction Inventory (CAPP-PSI).

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Typically Developing Children
1 of 2
3D Prostheses Users
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: 3D Printed Upper-limb Prosthesis · No Placebo Group · N/A

3D Prostheses UsersExperimental Group · 2 Interventions: 3D Printed Upper-limb Prosthesis, Home Intervention · Intervention Types: Device, Behavioral
Typically Developing Children
ActiveComparator Group · 1 Intervention: Home Intervention · Intervention Types: Behavioral
First Studied
Drug Approval Stage
How many patients have taken this drug
Home Intervention

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline of hemispheric dominance at 8 weeks.

Who is running the clinical trial?

University of NebraskaLead Sponsor
497 Previous Clinical Trials
1,150,677 Total Patients Enrolled

Eligibility Criteria

Age 3 - 18 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have problems with your arms or hands that make it difficult to use them normally.
You are missing any part of your arm or hand.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.