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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43HD095750-01 | U.S. NIH Grant/Contract | View source | |
| 120180305 | Other Identifier | NEIRB |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to evaluate the use of a voice activated prosthesis interface controller for functional outcomes as compared to standard prosthesis control.
The study will take place over two separate visits spaced about 1 week apart.
During the first visit participants will undergo informed consent. They will then be randomly assigned one of two test conditions, (a) standard control, or (b) voice recognition control.
For both conditions participants will be allowed to train on the control scheme until they are comfortable with it's usage. Subjects will then be asked to manipulate common objects as a test of improved control and utility. Functional outcome measures will be utilized to standardize the tasks performed and evaluate the advantages of voice control.
On the second visit participants will be assigned the alternate condition, allowed to train with the control scheme, and run through the same set of functional outcomes measures.
Upon completion of the second visit participants will be asked to fill out a questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Control | No Intervention | Use of standard two-site myoelectric control of multi-articulating hand. | |
| Voice Recognition Control | Experimental | Use of voice recognition control in addition to standard two-site myoelectric control of a multi-articulating hand. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voice Activated Prosthetic Interface (VAPI) Controller | Device | A device installed between a subjects socket quick disconnect wrist connection and multi-articulating hand which enables the use of voice as a control modality in addition to their standard two-site myoelectric control. |
| Measure | Description | Time Frame |
|---|---|---|
| University of New Brunswick (UNB) Test of Prosthetics Function | A Test for Unilateral Upper Limb Amputees | 2 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Custom Activities of Daily Living (ADL) Tasks | Timed completion of a set of custom ADL | 2 Days |
| Grip Switch Assessment (GSA) | Timed completion of a randomized set of multi-articulating hand grip switches |
| Measure | Description | Time Frame |
|---|---|---|
| Missed grips | A count of the number of intended missed grip changes | 2 Days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liberating Technologies, Inc. | Holliston | Massachusetts | 01746 | United States |
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| Label | URL |
|---|---|
| UNB Test of Prosthetics Function | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2020 | Apr 20, 2020 | ICF_000.pdf |
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Voice-Activated Prosthesis Interface
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| 2 Days |