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

Not Applicable

Not yet recruiting

• Conditions: Limb Deformities, Congenital; Upper Extremity Deformities, Congenital; Congenital Abnormalities
• Interventions: Device: 3D myoelectric prosthetic device

• Registration Number: NCT05547308
• Lead Sponsor: Orlando Health, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-04-25
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-16
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-21
• Study Start: 2022-11
• Primary Completion: 2025-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prosthetic device	3D myoelectric prosthetic device	All subjects will receive the 3D myoelectric prosthetic device

Primary Outcome Measures

Name	Time	Method
Quality of life and function ability will be measured through questionnaire, surveys and motor testing while using the 3D myoelectric device.	baseline thru 14 months post baseline.	This data will be compared across the population using validated testing tools.

Secondary Outcome Measures

Name	Time	Method
In-person testing of motor skills by an occupational therapist using blocks and a box.	baseline thru 14 months post baseline	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.

Trial Locations

Locations (1)

Orlando Health Arnold Palmer Hospital for Children; 🇺🇸 Orlando, Florida, United States