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| ID | Type | Description | Link |
|---|---|---|---|
| R42HD097827 | U.S. NIH Grant/Contract | View source |
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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 Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees 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 Digit partial hand prosthetic system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point Digit | Device | The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAL-1: System Comfort Validation Test | User wears Point Digit(s) for a full day (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be comfortable for a full day's use. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Day 1 (8 hours) |
| VAL-2: Unilateral Function Validation Test | User flexes and extends the Point Digit(s) without using contralateral hand (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall allow the user to flex and extend finger without their second hand. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Day 1 (10 minutes) |
| VAL-3.1: System Robustness Validation Test With 25 lb Bag | User lifts a 25 lb. bag with Point Digit(s) (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Day 1 (10 minutes) |
| VAL-3.2: Robustness Validation Test With Hammer |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Title | Description |
|---|---|---|
| FG000 | Prosthesis | Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prosthesis | Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | VAL-1: System Comfort Validation Test | User wears Point Digit(s) for a full day (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be comfortable for a full day's use. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Posted | Number | % of participants who Passed test | Day 1 (8 hours) |
|
an average of 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prosthesis | Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Point Designs | 7206004753 | research@pointdesigns.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2019 | Aug 21, 2024 | Prot_000.pdf |
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User grips a hammer with Point Digit(s) and drives a nail into a piece of wood (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. |
| Day 1 (10 minutes) |
| VAL-4: Object Release Validation Test | User releases Point Digit(s) while performing an active grasp by pressing the dorsal button (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be releasable while performing active grasps. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Day 1 (10 minutes) |
| VAL-5: Position Function Validation Test | User positions Point Digit(s) into each of the locking positions (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a smooth ratcheting mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Day 1 (10 minutes) |
| VAL-6: Extension Function Validation Test | User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a reliable auto spring-back mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Day 1 (10 minutes) |
| VAL-7: Grip Functions Validation Test | User grips a 5 lb. cylindrical smooth object using Point Digit(s) for 10 seconds (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have high grip surface friction. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Day 1 (10 minutes) |
| VAL-8: Fine Motor Function Validation Test | User picks up 1 coin from a smooth tabletop (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a pronounced fingernail. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Day 1 (10 minutes) |
| VAL-9: Overall Function & Robustness Validation Test | User performs VAL-1 through VAL-8 (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robustly attached to mounting system. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Day 1 (8 hours) |
| Lafayette |
| Colorado |
| 80026 |
| United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | VAL-2: Unilateral Function Validation Test | User flexes and extends the Point Digit(s) without using contralateral hand (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall allow the user to flex and extend finger without their second hand. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Posted | Number | % of participants who Passed test | Day 1 (10 minutes) |
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| Primary | VAL-3.1: System Robustness Validation Test With 25 lb Bag | User lifts a 25 lb. bag with Point Digit(s) (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Posted | Number | % of participants who Passed test | Day 1 (10 minutes) |
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| Primary | VAL-3.2: Robustness Validation Test With Hammer | User grips a hammer with Point Digit(s) and drives a nail into a piece of wood (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Posted | Number | % of participants who Passed test | Day 1 (10 minutes) |
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| Primary | VAL-4: Object Release Validation Test | User releases Point Digit(s) while performing an active grasp by pressing the dorsal button (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be releasable while performing active grasps. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Posted | Number | % of participants who Passed test | Day 1 (10 minutes) |
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| Primary | VAL-5: Position Function Validation Test | User positions Point Digit(s) into each of the locking positions (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a smooth ratcheting mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Posted | Number | % of participants who Passed test | Day 1 (10 minutes) |
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| Primary | VAL-6: Extension Function Validation Test | User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a reliable auto spring-back mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Posted | Number | % of participants who Passed test | Day 1 (10 minutes) |
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| Primary | VAL-7: Grip Functions Validation Test | User grips a 5 lb. cylindrical smooth object using Point Digit(s) for 10 seconds (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have high grip surface friction. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Posted | Number | % of participants who Passed test | Day 1 (10 minutes) |
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| Primary | VAL-8: Fine Motor Function Validation Test | User picks up 1 coin from a smooth tabletop (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a pronounced fingernail. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Posted | Number | % of participants who Passed test | Day 1 (10 minutes) |
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| Primary | VAL-9: Overall Function & Robustness Validation Test | User performs VAL-1 through VAL-8 (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robustly attached to mounting system. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test. | Posted | Number | % of participants who Passed test | Day 1 (8 hours) |
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| 0 |
| 7 |
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| 7 |
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