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| Name | Class |
|---|---|
| Limbitless Solutions | UNKNOWN |
| University of Central Florida | OTHER |
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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthetic Device | Experimental | 3D Printed Myoelectric Prosthetic Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Printed Myoelectric Prosthetic Device | Device | 3D Printed Myoelectric Prosthetic Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint - Measuring safety of the device through adverse event reporting. | The safety of the device will be measured through parental reporting and recorded observations of adverse events. | 12 months |
| Children's experiences of using the myoelectric device while performing bi-manual tasks as assessed using a self-report questionnaire. | 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. | 12 months |
| Detects expected change in a person's ability to to do various functions while performing a specific task and scoring their motions. | 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). | 12 months |
| This self-report or parent-report tool is used to assess musculoskeletal health of the myoelectric device user. | This assessment contains six scales Upper Extremity Physical Function; Mobility/Transfers; Sports/Physical Function; Pain/Comfort; Happiness; and Global Function. | 12 months |
| A self-report and parent-report sectional approach to measuring health-related quality of life. | This assessment uses four generic core scales including: physical health, emotional functioning, social functioning, and school functioning. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Chi, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Central Florida | Orlando | Florida | 32816 | United States | ||
| Oregon Health & Science University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17051527 | Background | 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. | |
| 20803406 | Background |
| Label | URL |
|---|---|
| Facts about Upper and Lower Limb Reduction Defects | View source |
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| ID | Term |
|---|---|
| D038062 | Upper Extremity Deformities, Congenital |
| ID | Term |
|---|---|
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
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| Portland |
| Oregon |
| 97239 |
| United States |
| 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. |
| Limbitless Solutions | View source |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |