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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-15-1-0575 | Other Grant/Funding Number | Congressionally Directed Medical Research Programs |
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| Name | Class |
|---|---|
| Louis Stokes VA Medical Center | FED |
| University of Alberta | OTHER |
| HDT Robotics | UNKNOWN |
| United States Department of Defense |
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To assess the functional characteristics and utility of upper and lower limb prosthetic devices (advanced bionic and current clinical standard-of-care) that incorporate physiologically relevant touch and/or movement feedback.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amputee and Able Bodied Subjects | Experimental | Map the locations in the skin or deeper muscle where limb movement perceptions occur. Use tactors (small robots providing touch and vibration) to mechanically provide sensation to the residual muscles in amputees and the intact muscles in able-bodied. The functional experiments will occur concurrently with development and application of new prosthetic socket designs to incorporate control and feedback. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tactor | Device | The tactor is a small robot providing touch and vibration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin or tendon location | Locations in the skin or muscle of the residual where percepts of touch or movement occur. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sorting Task | Performance on a sorting task with and without tactor feedback. | 36 months |
| Sense of Agency Questionnaire | Agreement with statements of agency and ownership related to perceptions of limb movement including unstructured self-reports. |
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Inclusion Criteria:
Inclusion criteria are adults (18 years or over) with major limb amputation (at or above wrist or ankle).
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Exclusion Criteria:
Exclusion criteria are any skin or pain conditions that would preclude ability to withstand pressures on their limb or to wear a prosthetic socket, or cognitive barriers precluding providing informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Marasco, PhD | The Cleveland Clinic | Principal Investigator |
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Significant scientific results and data will be shared. Final data sets will include information such as survey results, de-identified aggregate data of prosthetic users' abilities and functional outcomes, de-identified photographic/video. Non-proprietary/non-identifying data and findings will be disseminated in a timely manner through scientific seminars, meetings, and peer reviewed publications.
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Data will be shared within the 4-year time frame following the end of active protocols.
Data will be shared under the auspices of the principal investigator and data sharing will be done through a Cleveland Clinic issued, firewall protected FTP network server. Although the final data set will be stripped of identifiers, the possibility of deductive disclosure remains. Data/documentation will be available only under data-sharing agreements that provide for: (1) a commitment to data use only for research purposes only and non-identification of individuals; (2) a commitment to data security with using appropriate technology; and (3) a commitment to destroying/returning data after completed analyses.
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| FED |
| Congressionally Directed Medical Research Programs | FED |
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| 36 months |