NCT02887755

Assessing the Feasibility of a Novel Non-Invasive Sensor for Guiding Wounded Warrior Rehabilitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rehabilitation Post-amputation

Interventions

Type	Name	Description
DEVICE	Near-Infrared Spectroscopy (NIRS) Sensor	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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-09-02
• Last updated: 2018-04-02

Locations

1 site across 1 country: United States