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

Study Overview
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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.

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.

Official Title
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Evaluation of Gamified Training for 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency

Conditions
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Limb Deformities, Congenital, Upper Extremity Deformities, Congenital, Congenital Abnormalities

Intervention / Treatment
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* Device: 3D myoelectric prosthetic device


Participation Criteria
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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. Exclusion Criteria: Non-English-speaking children and families. Any shoulder or wrist disarticulation will be excluded.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prosthetic device<br>All subjects will receive the 3D myoelectric prosthetic device | Device: 3D myoelectric prosthetic device<br>* All subjects will use the 3D Prosthetic device and complete a variety of quality of life questionnaires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline thru 14 months post baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline thru 14 months post baseline |