Adherence Activity &Outcome Measure Belt for Yoga

Period of Performance: 09/30/2006 - 09/29/2009


Phase 1 SBIR

Recipient Firm

Cleveland Medical Devices, Inc.
Principal Investigator


DESCRIPTION (provided by applicant): Many clinical health improvements have been claimed to be possible through mind-body medicine techniques and yoga in particular. These claims are being tested throughout the scientific community to sort out legitimate claims from unsubstantiated claims. However, per RFA-AT-06-002, "understanding and accurately measuring the extent to which patients and study participants adhere to study protocols is essential to understand the dose, the efficacy, the safety, and the feasibility of the intervention." "Adherence is assessed using self- report diary measures or employing handheld devices. Both strategies are limited by potential participant bias, inaccuracy, and patient burden." This program will design, build and test a small wearable device that will monitor key physiological signals, including heart rate, thoracic and abdominal respiration rate, oxygen saturation and body position, such that patient adherence will be objectively recorded. In addition to adherence, activity performance and outcome measures will be recorded to monitor how well the exercises are being performed and how much affect the exercises have on the individuals." Although mind-body medicine techniques, and yoga in particular, have been around for a very long time and have been attributed with many health benefits, scientific evidence supporting those claims have been difficult to acquire. This program will develop a new device that will enable the scientific community to more easily perform the critical experiments that will determine which health benefits can be expected from this alternative medicine. Ultimately, a better understanding of these mind-body medicine techniques will lead to better medical treatments for everyone.