NCT05547308

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Orlando Health, Inc. · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-11-01
• Completion: 2027-11-01
• First posted: 2022-09-21
• Last updated: 2022-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study