Assessing the Feasibility of a Novel Non-Invasive Sensor for Guiding Wounded Warrior Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 6 Minute Walk Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
6 Minute Walk Test
时间窗: 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.
Single Stage Treadmill Test
时间窗: 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.
次要结局
- The Borg Rating of Perceived Exertion Scale (RPE)(Single Study Visit (Study consists of only one visit))