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

Orlando Health, Inc. logo

Orlando Health, Inc.

Status

Not yet enrolling

Conditions

Upper Extremity Deformities, Congenital
Limb Deformities, Congenital
Congenital Abnormalities

Treatments

Device: 3D myoelectric prosthetic device

Study type

Interventional

Funder types

Other

Identifiers

NCT05547308
2017710limbitlessprosthetic

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

7 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Prosthetic device
Experimental group
Description:
All subjects will receive the 3D myoelectric prosthetic device
Treatment:
Device: 3D myoelectric prosthetic device

Trial contacts and locations

1

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Central trial contact

Albert Manero, PhD

Data sourced from clinicaltrials.gov

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