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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Orlando Health, Inc.
Study ID
NCT05547308
Status
Not Yet Recruiting

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Conditions

  • Congenital Abnormalities
  • Limb Deformities, Congenital
  • Upper Extremity Deformities, Congenital

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 3D myoelectric prosthetic device — DEVICE
    All subjects will use the 3D Prosthetic device and complete a variety of quality of life questionnaires.

Study Details

This will be a prospective study over a 14-month duration with clinical evaluations throughout. Limitless Solutions will provide prosthetics and training system for study subjects that qualify for enrollment.

Key Dates

Start date
Nov 30, 2022
Status verified
Sep 2022
Primary completion
Nov 30, 2025
Completion
Nov 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Prosthetic device
    All subjects will receive the 3D myoelectric prosthetic device

Primary Outcome Measure

Quality of life and function ability will be measured through questionnaire, surveys and motor testing while using the 3D myoelectric device. [ Time Frame: baseline thru 14 months post baseline. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Orlando Health Arnold Palmer Hospital for ChildrenOrlandoFlorida32806
Denise R. Lopez, APRN MSN
[email protected]
Jason Keeler, MS
[email protected]
Mark A. Birnbaum, MD (PRINCIPAL_INVESTIGATOR)
James E. Toledano, MD (SUB_INVESTIGATOR)

Find similar trials in Orlando, FL

By research site
Orlando Health Arnold Palmer Hospital for Children· Orlando, FL

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