Abstract
BACKGROUNDThis study describes the development and validation of a non-invasive wearable device to provide haptic feedback and train sensory discrimination. The ultimate aim of this device is to be used as part of a treatment for functional and/or pain rehabilitation due to sensorimotor impairment.METHODSThe development was guided by a structured design control process to ensure the verifiability and validity of the design outcomes. Two sub-systems were designed to systematically provide various types of somatosensory stimulation: 1) a tactile display for touch and vibration, and 2) a set of bands for sliding, pressure, and strain sensations. The device was designed with a versatile structure that allows for its application on different body parts. We designed an interactive computer program to command the device and enable training sessions. The validation of the device was performed with 11 able-bodied individuals whose upper arm tactile sensitivity was measured over 5 training sessions conducted daily. Tactile discrimination and perception threshold were measured using the standard 2-point discrimination and Semmes-Weinstein monofilament tests, respectively.RESULTSThe development and verification procedures ensured that the device successfully complied with the pre-established requirements, which were selected to enable the device clinical application. The results on tactile discrimination and sensitivity showed high subject-dependent variability but trended towards improvement (p=0.05). This trend was also confirmed by the scores achieved during the training sessions.CONCLUSIONSWe introduced a wearable device to deliver somatosensory stimulation and to train sensory discrimination. The design is versatile enough to allow for its application on different body parts. The device was found robust enough for clinical application, and it showed to increase tactile sensitivity on upper arms of able-bodied individuals. Further studies will be conducted to determine if our current findings transfer to individuals with sensorimotor impairment and if this approach is suitable for functional and/or pain rehabilitation after sensorimotor impairments.
Development and validation of diagnostic and pharmacodynamic cancer biomarker methods
and their (pre)clinical application
