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

N/ANot Yet RecruitingNCT05547308

Orlando Health, Inc.20 enrolled

Overview

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.

Prosthetics for children are costly and those families who do get them often find that children don't use them for very long for a variety of reasons, including weight and ease of use. Limitless Solutions has developed technology to create personalized bionics for people with disabilities at an affordable cost. 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 free of charge. During each visit, the study team will include an occupational therapist, a prosthetist, a study coordinator, and a research volunteer along with Limitless support staff and a supervising physician. Subject will complete quality of life questionnaires throughout their participation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Limb Deformities, Congenital Upper Extremity Deformities, Congenital Congenital Abnormalities

Interventions

3D myoelectric prosthetic deviceDEVICE

All subjects will use the 3D Prosthetic device and complete a variety of quality of life questionnaires.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children between the ages of 7 to 17 * Congenital/infant upper limb deficiency specifically transhumeral and transradial limb deficiency as identified by Limbitless Solutions. Exclusion Criteria: * Non-English-speaking children and families. * Any shoulder or wrist disarticulation will be excluded.

Locations (1)

Orlando Health Arnold Palmer Hospital for Children

Orlando, Florida, United States

Outcomes

Primary Outcomes

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

This data will be compared across the population using validated testing tools.

Time frame: baseline thru 14 months post baseline.

Secondary Outcomes

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

Box and Blocks Test measures gross motor dexterity skills with an experienced occupational therapist with both dominant and non-dominant hand by moving blocks into a box in a specific timeframe while using the 3D myoelectric prosthetic device. This will be done at delivery of device, 5 months and 14 months after delivery.

Time frame: baseline thru 14 months post baseline

Central Contacts

Albert Manero, PhD

CONTACT

407 823-6757 contact@limbitless-solutions.org

Data from ClinicalTrials.gov

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