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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quality of life and function ability will be measured through questionnaire, surveys and motor testing while using the 3D myoelectric device.
Secondary study objectives
In-person testing of motor skills by an occupational therapist using blocks and a box.
Other study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prosthetic deviceExperimental Treatment1 Intervention
All subjects will receive the 3D myoelectric prosthetic device

Find a Location

Who is running the clinical trial?

University of Central FloridaOTHER
93 Previous Clinical Trials
1,120,206 Total Patients Enrolled
Orlando Health, Inc.Lead Sponsor
31 Previous Clinical Trials
15,097 Total Patients Enrolled
Limbitless SolutionsUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Albert Manero, PhDStudy DirectorLimbitless Solutions

Media Library

3D Myoelectric Prosthetic Device (Prosthetics) Clinical Trial Eligibility Overview. Trial Name: NCT05547308 — N/A
Genetic Disorders Research Study Groups: Prosthetic device
Genetic Disorders 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
~5 spots leftby Nov 2025
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