Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Completed
NCT Number: NCT02887755
Assessing the Feasibility of a Novel Non-Invasive Sensor for Guiding Wounded Warrior Rehabilitation
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Military health care beneficiary and veterans for enrollment.
- Between 18 and 45 year old.
- Possess a unilateral transtibial or transfemoral amputation.
- Low risk for cardiovascular disease.
- Ambulatory without assistive ambulatory device.
Exclusion criteria
- Exclusion criteria includes individuals outside of our age range or if over the age of 18 and under the age of 45 will be excluded if found at risk according to the ACSM/AHA pre-participation screening questionnaire for exercise testing.
- Told by a doctor that they should not exercise.
- Orthopedic injury/surgery of the lower extremity within the last year
- Less than 5" x 2.5" of soft tissue proximal to the prostheses (since the sensor will need to be placed on the soft tissue proximally)
- Hip or shoulder disarticulation.
- Regular use of medications designed to alter cardiovascular function;
- Unwilling to comply with the study protocol.
- Individuals with a fat layer greater than 10mm in correspondence of the location of the NIRS probe (thigh).
- Allergic reaction to latex, cotton, or polyester, which are the primary materials of an ace bandage.
Treatment and study plan
Near-Infrared Spectroscopy (NIRS) Sensor
DeviceThese 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.
Primary outcomes
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Single Stage Treadmill Test
Time frame: Single Study Visit (Study consists of only one visit)
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.
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6 Minute Walk Test
Time frame: Single Study Visit (Study consists of only one visit)
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.
Secondary outcomes
-
The Borg Rating of Perceived Exertion Scale (RPE)
Time frame: Single Study Visit (Study consists of only one visit)
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.
Sponsors and collaborators
Lead sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Other
Collaborators
- Walter Reed National Military Medical Center
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Sep 2, 2016
- Registry last updated
- Apr 2, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.