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| Name | Class |
|---|---|
| Walter Reed National Military Medical Center | FED |
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The purpose of this study is to test a low cost, non-invasive, wearable near-infrared spectroscopy (NIRS) sensor, previously validated for able-bodied athletes as a rehabilitation aid for war-fighters with lower extremity limb loss. This sensor can record real-time physiologic data that relates to total fitness capacity and exertion levels and may help develop individualized programs on a per-patient basis. The uniqueness of this NIRS measurement system is that it provides real-time muscular oxygenation, dehydration, and iron status during whole-body exercise, as well as training-induced adaptations. Currently, no technology like this has been tested in an amputee population. Successfully validating this technology in a wounded warrior population would provide vital information regarding tissue perfusion after injury and new opportunities for improving rehabilitation outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amputee Group | Experimental | In this study n=20 returning US military combatants between 18 and 45 years of age who have unilateral transtibial or transfemoral amputation will be asked to perform two aerobic exercise tests while we4aring the NIRS sensor. Subjects must be medically cleared and able to complete approximately 30 minutes of physical activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near-Infrared Spectroscopy (NIRS) Sensor | Device | These sensors utilize NIRS to evaluate oxygenated and deoxygenated hemoglobin, total oxygenation index and total blood flow. This is done by bouncing infrared light off of chromatophores (located within red blood cells), which is then refracted off of the cells in the capillary beds to the topical sensor. |
| Measure | Description | Time Frame |
|---|---|---|
| Single Stage Treadmill Test | The single stage treadmill test is a valid and easily performed submaximal test that estimates the VO2max of healthy adults aged 20-59 years. The test involves a 4 minute warm up at 0% grade at a self-selected walking speed that elicits a heart rate within 50-70% of the individual's age-predicted maximum heart rate. | Single Study Visit (Study consists of only one visit) |
| 6 Minute Walk Test | The test measures the distance that an individual can walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. | Single Study Visit (Study consists of only one visit) |
| Measure | Description | Time Frame |
|---|---|---|
| The Borg Rating of Perceived Exertion Scale (RPE) | The RPE scale measures feelings of effort, strain, discomfort and/or fatigue experienced during both aerobic and resistance training. It is based on the physical sensations a person experiences during physical activity, including increased heart rate, increased respiration or breathing rate, increased sweating, and muscle fatigue. | Single Study Visit (Study consists of only one visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 12, 2019 | |
| Reset | May 8, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 12, 2019 | May 8, 2019 |
| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |