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| ID | Type | Description | Link |
|---|---|---|---|
| 4R44HD113485-02 | U.S. NIH Grant/Contract | View source |
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Early termination of funding
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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthesis | Experimental | Patient is temporarily fit with Point Mini finger prosthetic system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point Mini | Device | The Point Mini finger prosthetic system consists of 1-4 ratcheting mechanical digits and mounting brackets |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAL-1 | User wears Point Mini(s) for a entire session without discomfort (Pass/Fail) | Day 1 (8 hours) |
| VAL-2 | User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail) | Day 1 (10 minutes) |
| VAL-3.1 | User lifts a 10-25 lb bag with Point Mini(s) depending on age (Pass/Fail) | Day 1 (10 minutes) |
| VAL-3.2 | User grips a hammer with Point Mini(s) and makes indentations into the wood (Pass/Fail) | Day 1 (10 minutes) |
| VAL-4 | User releases Point Mini(s) while performing an active grasp by pressing the dorsal button ten times sequentially (Pass/Fail) | Day 1 (10 minutes) |
| VAL-5 | User positions Point Mini(s) into each of the locking positions without binding (Pass/Fail) | Day 1 (10 minutes) |
| VAL-6 | User activates spring-back mechanism ten times without failure by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail) | Day 1 (10 minutes) |
| VAL-7 | User grips a 5 lb cylindrical smooth object using Point Mini(s) for 10 seconds (Pass/Fail) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Levin Sliker, PhD | CEO, Point Designs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| Point Designs |
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| ID | Term |
|---|---|
| C565682 | Amputation, Congenital |
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| Day 1 (10 minutes) |
| VAL-8 | User picks up 4 coins from a smooth tabletop within 30 seconds (Pass/Fail) | Day 1 (10 minutes) |
| VAL-9 | User performs VAL-1 through VAL-8 without Point Mini releasing from mounting system (Pass/Fail) | Day 1 (8 hours) |
| Lafayette |
| Colorado |
| 80026 |
| United States |