Clinical trial NCT04059107: Prosthetic Device in Children With Upper Congenital Limb Deficiency
Official title: Evaluation of 3D Printed Myoelectric Prosthetics in Children With Upper Congenital Limb Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Limb Deformities, Congenital
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Limbitless Solutions
name: University of Central Florida
First posted: 2019-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study being performed to evaluate the safety and effectiveness of 3D printed myoelectric prosthetic devices in children with a congenital upper limb deficiency.

Detailed description: The purpose of this study is to learn more about whether myoelectric prosthetic devices would be beneficial and useful for children. The study protocol specifies 4 study visits over the course of a year at the following intervals: baseline, 3 month, 6 month, 12 months. In following the protocol, each study visit will use the Assessment of Capacity for Myoelectric Control (ACMC) functional testing. The study participants will also complete several parent-child reported health related quality of life and musculoskeletal questionnaires. Specifically, the Pediatric Outcomes Data Collection Instrument (PODCI), the Pediatric Quality of Life Inventory (PedsQL), and the Children's Hand-Use Experience Questionnaire (CHEQ) will be used to measure efficacy of the myoelectric devices..

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 6 to 17 with congenital/infant upper limb deficiency identified by Limbitless Solutions will be referred to OHSU for evaluation and selection.
* All approved and consented subjects will receive a Limbitless 3D printed myoelectric device as delivered by established protocol.
* Preference will be given to children with long term previous experience with Limbitless Solutions' bionic systems.

Exclusion Criteria:

* Non English-speaking children and families. Due to the entirely volunteer nature of this project, the investigators are unable to hire appropriate translation services or create translated forms and surveys in other languages currently.
* Shoulder or wrist disarticulation will be excluded.

Primary outcomes:
measure: Primary Safety Endpoint - Measuring safety of the device through adverse event reporting.
timeFrame: 12 months
measure: Children's experiences of using the myoelectric device while performing bi-manual tasks as assessed using a self-report questionnaire.
timeFrame: 12 months
measure: Detects expected change in a person's ability to to do various functions while performing a specific task and scoring their motions.
timeFrame: 12 months
measure: This self-report or parent-report tool is used to assess musculoskeletal health of the myoelectric device user.
timeFrame: 12 months
measure: A self-report and parent-report sectional approach to measuring health-related quality of life.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: The University of Central Florida
state: Florida
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Albert Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.