Clinical trial NCT05547308: Evaluation of 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency
Official title: Evaluation of Gamified Training for 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Limb Deformities, Congenital
Upper Extremity Deformities, Congenital
Congenital Abnormalities
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
Collaborators: name: Limbitless Solutions
name: University of Central Florida
First posted: 2022-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life and function ability will be measured through questionnaire, surveys and motor testing while using the 3D myoelectric device.
timeFrame: baseline thru 14 months post baseline.
Secondary outcomes:
measure: In-person testing of motor skills by an occupational therapist using blocks and a box.
timeFrame: baseline thru 14 months post baseline
Other outcomes:
measure: Children's Hand-use Experience Questionnaire
timeFrame: baseline thru 14 months post baseline
measure: PedsQL TM (Pediatric Quality of Life Inventory TM)
timeFrame: baseline thru 14 months post baseline
measure: The use of the GUESS system for video gaming using the myoelectric device.
timeFrame: baseline thru 14 months post baseline
measure: The Pediatric Outcome Data Collection Instrument is a survey
timeFrame: baseline thru 14 months post baseline
measure: Psychosocial questionnaire to be completed by both patient and parent
timeFrame: 14 month post baseline
Locations:
city: Orlando
country: United States
facility: Orlando Health Arnold Palmer Hospital for Children
state: Florida
Study officials:
affiliation: Limbitless Solutions
name: Albert Manero, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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 Mol Teratol. 2006 Nov;76(11):747-56. doi: 10.1002/bdra.20294.