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| ID | Type | Description | Link |
|---|---|---|---|
| RX003090-01A2 | Other Grant/Funding Number | Dept Veterans Affairs |
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Prostheses can be suspended from the amputated limb using a variety of techniques, such as straps and suction. Suspending the prosthesis by creating a vacuum between the prosthetic socket and limb using a pump has benefits over other techniques including improved limb health and mobility. A new pump design will be tested by prosthesis users in the laboratory to verify its functionality during walking.
Human subject testing will involve a cross-sectional, repeated measures study consisting of a single 3 hour visit wherein participants will initially stand and then continuously walk at their self-selected speed for ten minutes on a level treadmill with the prototype under two randomly presented conditions of the mechanical system: 1) fully functional, and 2) locked to restrict axial displacement. After written informed consent is obtained, information on socket comfort and mobility capability will be collected. A load-cell will be installed proximal to the prototype and in-line with the prosthesis to measure instantaneous socket-reaction moments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locked | Experimental | The prototype mechanical system is locked from compressing |
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| Unlocked | Experimental | The prototype mechanical system is free to compress normally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pump prototype | Other | Effects of pump function on gait |
|
| Measure | Description | Time Frame |
|---|---|---|
| Socket-reaction moments | Maximum moment (torques) generated at the prosthetic socket end during walking | Immediate |
| Measure | Description | Time Frame |
|---|---|---|
| Socket Comfort | Comfort of the prosthetic socket | Immediate |
| Perceived mobility capability | Mobility capability as reported by the participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J. Major, PhD | Jesse Brown VA Medical Center, Chicago, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States |
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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 | Apr 5, 2024 | May 6, 2026 |
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Randomly assigned conditions of pump function to characterize the effects of added movement on socket-reaction torques
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| Immediate |
| ICF_000.pdf |