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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2027-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Limb Deformities, Congenital Upper Extremity Deformities, Congenital Congenital Abnormalities

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prosthetic device

All subjects will receive the 3D myoelectric prosthetic device

Group Type EXPERIMENTAL

3D myoelectric prosthetic device

Intervention Type DEVICE

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

Interventions

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3D myoelectric prosthetic device

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

Intervention Type DEVICE

Eligibility Criteria

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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.