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Prosthetics

3D Printed Prosthetics for Congenital Limb Deformities

N/A

Waitlist Available

Research Sponsored by Orlando Health, Inc.

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 month post baseline

Awards & highlights

Study Summary

This trial will last 14 months and have regular check-ups. The company Limitless Solutions will provide free prosthetics and training for people who qualify to participate.

Who is the study for?

This trial is for children aged 7 to 17 with congenital upper limb deficiencies, specifically missing parts of the arm above or below the elbow. Participants must speak English. Children with shoulder or wrist disarticulation are not eligible.Check my eligibility

What is being tested?

The study tests a new type of prosthetic arm that's made using 3D printing and can be controlled by muscle signals (myoelectric). It will last for over a year, and kids will get these arms along with training on how to use them.See study design

What are the potential side effects?

Since this trial involves non-invasive prosthetic devices, there are no direct medical side effects like you'd see with drugs. However, kids might experience discomfort or need time to adjust to using the device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 month post baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 month post baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 month post baseline for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Quality of life and function ability will be measured through questionnaire, surveys and motor testing while using the 3D myoelectric device.

Secondary outcome measures

In-person testing of motor skills by an occupational therapist using blocks and a box.

Other outcome measures

Children's Hand-use Experience Questionnaire

PedsQL TM (Pediatric Quality of Life Inventory TM)

Psychosocial questionnaire to be completed by both patient and parent

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prosthetic deviceExperimental Treatment1 Intervention

All subjects will receive the 3D myoelectric prosthetic device

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Central FloridaOTHER

78 Previous Clinical Trials

1,097,456 Total Patients Enrolled

Orlando Health, Inc.Lead Sponsor

28 Previous Clinical Trials

12,723 Total Patients Enrolled

Limbitless SolutionsUNKNOWN

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

3D Myoelectric Prosthetic Device (Prosthetics) Clinical Trial Eligibility Overview. Trial Name: NCT05547308 — N/A

Congenital Limb Deformities Research Study Groups: Prosthetic device

Congenital Limb Deformities Clinical Trial 2023: 3D Myoelectric Prosthetic Device Highlights & Side Effects. Trial Name: NCT05547308 — N/A

3D Myoelectric Prosthetic Device (Prosthetics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05547308 — N/A

Frequently Asked Questions

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

Is the upper age limit for this medical experiment sixty years or less?

"The lower limit of eligibility for this trial is 7 years old, while the upper age cap has been set at 17."

Answered by AI

To whom is enrollment in this clinical experiment accessible?

"To take part in this medical trial, subjects must be between 7 and 17 years of age with a congenital limb deformity. This clinical study is open to up to 20 participants."

Answered by AI

Is there an open enrollment period for this research initiative?

"Unfortunately, the clinical trial is not currently recruiting patients. As indicated on clinicaltrials.gov, this study was initially posted on November 1st 2022 and edited for the last time on September 16th of that same year. Although no longer accepting applicants to this specific investigation, there are 118 other studies searching for participants at present."

Answered by AI

Recent research and studies

Birth Defects Research Part A: Clinical and Molecular TeratologyJournal

National Estimates and Race/ethnic-specific Variation of Selected Birth Defects in the United States, 1999–2001

Canfield, Mark A., Margaret A. Honein, Nataliya Yuskiv, Jian Xing, Cara T. Mai, Julianne S. Collins, Owen Devine, et al.. 2006. “National Estimates and Race/ethnic-specific Variation of Selected Birth Defects in the United States, 1999–2001”. Birth Defects Research Part A: Clinical and Molecular Teratology. Wiley. doi:10.1002/bdra.20294.

The Journal of Rehabilitation Research and DevelopmentJournal

Prosthetic Cost Projections for Servicemembers with Major Limb Loss from Vietnam and OIF/OEF

Blough, David K., Sharon Hubbard, Lynne V. McFarland, Douglas G . Smith, Jeffrey M. Gambel, and Gayle E. Reiber. 2010. “Prosthetic Cost Projections for Servicemembers with Major Limb Loss from Vietnam and OIF/OEF”. The Journal of Rehabilitation Research and Development. Journal of Rehabilitation Research & Development. doi:10.1682/jrrd.2009.04.0037.

clinicaltrials.govStudy

Evaluation of 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency

2022. "Evaluation of 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05547308.