Prosthetic Device in Children With Upper Congenital Limb Deficiency
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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..
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prosthetic Device 3D Printed Myoelectric Prosthetic Device |
Device: 3D Printed Myoelectric Prosthetic Device
3D Printed Myoelectric Prosthetic Device
|
Outcome Measures
Primary Outcome Measures
- Primary Safety Endpoint - Measuring safety of the device through adverse event reporting. [12 months]
The safety of the device will be measured through parental reporting and recorded observations of adverse events.
- Children's experiences of using the myoelectric device while performing bi-manual tasks as assessed using a self-report questionnaire. [12 months]
This assessment will measure the ability of the user to perform day-to-day tasks on three scales: grasp, performance time, and level of frustration.
- Detects expected change in a person's ability to to do various functions while performing a specific task and scoring their motions. [12 months]
This assessment will evaluate the ability of the myoelectric device use on functions that involve griping, holding, releasing, and coordinating between limbs using the Assessment of Capacity for Myoelectric Control (ACMC).
- This self-report or parent-report tool is used to assess musculoskeletal health of the myoelectric device user. [12 months]
This assessment contains six scales Upper Extremity Physical Function; Mobility/Transfers; Sports/Physical Function; Pain/Comfort; Happiness; and Global Function.
- A self-report and parent-report sectional approach to measuring health-related quality of life. [12 months]
This assessment uses four generic core scales including: physical health, emotional functioning, social functioning, and school functioning.
Eligibility Criteria
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.
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Preference will be given to children with long term previous experience with Limbitless Solutions' bionic systems.
Exclusion Criteria:
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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.
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Shoulder or wrist disarticulation will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Central Florida | Orlando | Florida | United States | 32816 |
| 2 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Oregon Health and Science University
- Limbitless Solutions
- University of Central Florida
Investigators
- Principal Investigator: Albert Chi, MD, Oregon Health and Science University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
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.
- 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.
- OHSU IRB17087