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

Congenital Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05547308
• Other study ID #: 2017710limbitlessprosthetic
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: November 2027

Study information

• Verified date: September 2022
• Source: Orlando Health, Inc.
• Contact: Albert Manero, PhD
• Phone: 407 823-6757
• Email: contact[@]limbitless-solutions.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2027
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Upper Extremity Deformities, Congenital

Intervention

Device:
• 3D myoelectric prosthetic device
All subjects will use the 3D Prosthetic device and complete a variety of quality of life questionnaires.

Locations

Country	Name	City	State
United States	Orlando Health Arnold Palmer Hospital for Children	Orlando	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Orlando Health, Inc.	Limbitless Solutions, University of Central Florida

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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

External Links

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