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.
- Congenital Upper Extremity Deformities
- Amniotic Band Syndrome
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
4 Primary · 2 Secondary · Reporting Duration: Change from baseline of hemispheric dominance at 8 weeks.
Trial Safety
Phase-Based Safety
Awards & Highlights
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 3 - 18 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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.
- Jorge M. Zuniga 2020. "The Influence of 3D Printed Prostheses on Neural Activation Patterns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04110730.
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
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
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
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