2 research outputs found
Enhancing the measurement of clinical outcomes using Microsoft Kinect
There is a growing body of applications leveraging Microsoft Kinect and the associated Windows Software Development Kit in health and wellness. In particular, this platform has been valuable in developing interactive solutions for rehabilitation including creating more engaging exercise regimens and ensuring that exercises are performed correctly for optimal outcomes.
Clinical trials rely upon robust and validated methodologies to measure health status and to detect treatment-related changes over time to enable the efficacy and safety of new drug treatments to be assessed and measured. In many therapeutic areas, traditional outcome measures rely on subjective investigator and patient ratings. Subjective ratings are not always sensitive to detecting small improvements, are subject to inter- and intra-rater variability and limited in their ability to record detailed or subtle aspects of movement and mobility. For these reasons, objective measurements may provide greater sensitivity to detect treatment-related changes where they exist.
In this review paper, we explore the use of the Kinect platform to develop low-cost approaches to objectively measure aspects of movement. We consider published applications that measure aspects of gait and balance, upper extremity movement, chest wall motion and facial analysis. In each case, we explore the utility of the approach for clinical trials, and the precision and accuracy of estimates derived from the Kinect output.
We conclude that the use of games platforms such as Microsoft Kinect to measure clinical outcomes offer a versatile, easy to use and low-cost approach that may add significant value and utility to clinical drug development, in particular in replacing conventional subjective measures and providing richer information about movement than previously possible in large scale clinical trials, especially in the measurement of gross spatial movements. Regulatory acceptance of clinical outcomes collected in this way will be subject to comprehensive assessment of validity and clinical relevance, and this will require good quality peer-reviewed publications of scientific evidence
Recommended from our members
Implementing smart materials and technologies for medical emergency airway access devices
Airway management and intubation procedures continue to challenge anaesthetists daily. Failure to secure the airway with an endotracheal tube in a timely manner upon induction of anaesthesia can lead to serious complications, including death or disability. Most anaesthetists consider endotracheal tube introducers (bougies) as essential equipment; however, there are many different types with relatively little performance data to help anaesthetists make an informed choice. Standard bougies have a requirement to be reshaped multiple times in an attempt to create the desired navigation path of the endotracheal tube. Manoeuvring within the trachea presents significant navigation and control challenges whilst attempting to minimise trauma. Improvements in airway management care is often facilitated by the introduction of new or improved airway management equipment, however understanding their physical properties is imperative for the development of an improved device. This research addresses the development of a new emergency airway access device; the steerable bougie has been designed to enhance device control and improve the speed and the safety of bougie guided endotracheal intubation.
Initial work focussed on assessing the case of need for the development of an improved bougie, in addition to identifying design criteria and specifications. A number of anaesthetists were surveyed and identified increased manoeuvrability in-situ, improved shape retention and steerable control as desirable device attributes. Initial design, development and testing explored the feasibility of actuators and smart materials capable of replicating a steerable movement. Initial prototyping and testing demonstrated that flexible steerable tips controlled by Flexinol® actuator wires could effectively control the navigation of the tip.
Understanding the physical properties of bougies is fundamental to patient safety, device operation and ultimately equipment procurement decisions. Accurate and reliable bougie safety performance data, including perforation forces, bougie tip pressures and shape retention is not available. Equipment evaluations often fail to consider key testing criteria including testing equipment specifications. Tip pressure studies conducted identified current equipment weaknesses with airway trauma, including significant mucosa damage and perforation easily achieved by low tip pressure forces. The steerable bougie demonstrated significantly lower tip pressure forces compared to commercially available bougies. Repeatability testing conducted assessing tip pressure performance identified variable degradation over time for all commercially available bougies; the developed steerable bougie presented limited degradation over time.
Anaesthetists define shape retention as a critical performance characteristic for a bougie. To match the curvature of a patient's airway multiple bougie shaping iterations are usually required, however bougies often return to their original shape within seconds of being manipulated. All bougies present initial snap back and shape loss. To identify bougies with optimal shape retention, an innovative Shape Retention Testing System (SRTS) was designed and built to test shape retention characteristics. Testing demonstrated that bougies with dual or multi-lumened structures provided the highest level of shape retention hold. The steerable bougie outperformed the commercially available bougies at most shaping distances, demonstrating limited shape loss.
Utilising the accumulated bougie performance data, a steerable bougie with improved shape retention, reduced tip pressures and reduced likelihood of causing airway trauma has been developed. The steerable bougie is connected to an ergonomically designed controller attached to a laryngoscope that can also be easily attached/detached and sterilised.
This research has demonstrated that a steerable bougie with augmented physical properties can be developed that not only provides medical professionals with a device that has increased steerability and usability for time critical procedures but will also reduce the likelihood of patient airway trauma