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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-MR140125 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Socket 1 (Ischial Ramus Containment) | Active Comparator | This arm included unilateral transfemoral amputees who were assessed while using the Ischial Ramus Containment socket. |
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| Socket 2 (Dynamic Socket IRC) | Active Comparator | This arm included unilateral transfemoral amputees who were assessed while using the Dynamic Socket Ischial Ramus Containment socket. |
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| Socket 3 (Sub-Ischial Interface) | Active Comparator | This arm included unilateral transfemoral amputees who were assessed while using the Sub-Ischial Interface socket. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ischial Ramus Containment (IRC) | Device | Ischial Ramus Containment (IRC) is the standard of care socket |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin Temperature | Continuous skin temperature measurement (Celsius) will be taken during treadmill walking at self-selected comfortable speed | Accommodation with new prosthetic sockets is approximately 10 days |
| Perspiration | Perspiration will be measured by tare weight (grams) following treadmill walking. | Accommodation with new prosthetic sockets is approximately 10 days |
| Vertical Interface Movement (Pistoning) | Pistoning will be defined as the numerical difference of interface to skeletal movement (cm) between simulated swing (lifting the prosthetic side) and stance (single support on the prosthetic side) as measured by coronal X-Ray. | Accommodation with new prosthetic sockets is approximately 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Balance and Stability | The gold standard test of standing balance is the sensory organization test (SOT) administered on the Neurocom Equitest platform. The SOT score is a unitless number. Subjects stand on a pair of platforms that record force data and tilt in the sagittal plane during 6 varying conditions that challenge the visual, vestibular and somatosensory systems. With compromised ability to use an ankle strategy for balance, a hip strategy is routinely adopted, therefore higher interface trim lines could adversely affect performance on this test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Highsmith, PhD, CP, PT | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33856157 | Derived | Kahle JT, Miro RM, Ho LT, Porter MR, Lura DJ, Carey SL, Lunseth P, Swanson AE, Highsmith MJ. Effect of transfemoral prosthetic socket interface design on gait, balance, mobility, and preference: A randomized clinical trial. Prosthet Orthot Int. 2021 Aug 1;45(4):304-312. doi: 10.1097/PXR.0000000000000013. |
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| Dynamic Socket Ischial Ramus Containment (IRC) | Device | Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket |
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| Sub-Ischial Interface (Sub-I) | Device | Sub-Ischial Interface (Sub-I) is a comparator study socket |
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| Accommodation with new prosthetic sockets is approximately 10 days |
| Comfort | The Socket Comfort Score (rated on an 11-point 0-10 scale) will be used to assess patients' comfort in the respective sockets. | Accommodation with new prosthetic sockets is approximately 10 days |
| Preference | Patients will be asked which socket they preferred. | Accommodation with new prosthetic sockets is approximately 10 days |