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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Abnormalities; Limb Deformities, Congenital; Upper Extremity Deformities, Congenital
• Intervention / Treatment: Device: 3D myoelectric prosthetic device

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Albert Manero, PhD; Phone Number: 407 823-6757; Email: contact@limbitless-solutions.org

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Arnold Palmer Hospital for Children
      • Contact: Denise R. Lopez, APRN MSN; Email: denise.lopez@orlandohealth.com
      • Contact: Jason Keeler, MS; Email: jason.keeler@orlandohealth.com
      • Principal Investigator: Mark A. Birnbaum, MD
      • Sub-Investigator: James E. Toledano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Hand-use Experience Questionnaire	Children's Hand-use Experience Questionnaire is in PDF format We have developed the questionnaire to evaluate the experience of children and adolescents in using the affected hand or hand prostheses in activities where usually two hands are needed.	baseline thru 14 months post baseline
PedsQL TM (Pediatric Quality of Life Inventory TM)	The PedsQL Measurement Model is a questionnaire that is designed to measure health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions.	baseline thru 14 months post baseline
The use of the GUESS system for video gaming using the myoelectric device.	The GUESS is a psychometrically validated and comprehensive gaming scale with nine subscales (e.g., Usability/Playability, Creative Freedom, and Social Connectivity) and 55 items in total. The GUESS is intended for any playtesting and game evaluation purposes.	baseline thru 14 months post baseline
The Pediatric Outcome Data Collection Instrument is a survey	The Pediatric Outcomes Data Collection Instrument (PODCI) is an outcomes assessment tool developed to allow measurement of health-related quality of life in children with disorders having musculoskeletal impact. This can be patient or parent reported and addresses activities of daily living.	baseline thru 14 months post baseline
Psychosocial questionnaire to be completed by both patient and parent	This survey is designed to qualitatively identify any influence the use of the prosthetic device has throughout the study and for qualitative comparison across the patient population.	14 month post baseline

Collaborators and Investigators

• Sponsor: Orlando Health, Inc.
• Collaborators: University of Central Florida; Limbitless Solutions
• Investigators: Study Director: Albert Manero, PhD, Limbitless Solutions

Publications and helpful links

General Publications

• Blough DK, Hubbard S, McFarland LV, Smith DG, Gambel JM, Reiber GE. Prosthetic cost projections for servicemembers with major limb loss from Vietnam and OIF/OEF. J Rehabil Res Dev. 2010;47(4):387-402. doi: 10.1682/jrrd.2009.04.0037.
• Canfield MA, Honein MA, Yuskiv N, Xing J, Mai CT, Collins JS, Devine O, Petrini J, Ramadhani TA, Hobbs CA, Kirby RS. National estimates and race/ethnic-specific variation of selected birth defects in the United States, 1999-2001. Birth Defects Res A Clin Mol Teratol. 2006 Nov;76(11):747-56. doi: 10.1002/bdra.20294.

Helpful Links

• Limbitless Solutions, Inc.
• Facts about Upper and Lower Limb Reduction Defects

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2025
• Study Completion (Anticipated): November 1, 2027

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Limb Deformities, Congenital; Upper Extremity Deformities, Congenital
• Other Study ID Numbers: 2017710limbitlessprosthetic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No