Miniaturized wearable Inertial Measurement Units (IMU) offer new opportunities for the functional assessment of motor functions for medicine, sport, and ergonomics. Sparse reliability validation studies have been conducted without a common specific approach and protocol. A set of guidelines to design validation protocol for these systems is proposed hereafter. They are based on the comparison between video analysis and the gold standard optoelectronic motion capture system for Gait Analysis (GA). A setup of the protocol has been applied to a wearable device implementing an inertial measurement unit and a dedicated harmonic oscillator kinematic model of the center of mass. In total, 10 healthy volunteers took part in the study, and four trials of walking at a self-selected speed and step length have been simultaneously recorded by the two systems, analyzed, and compared blindly (40 datasets). The model detects the steps and the foot which supports body weight. The stride time and the cadence have a mean absolute percentage error of 5.7% and 4.9%, respectively. The mean absolute percentage error in the measurement of step’s length and step’s speed is 5.6% and 13.5%, respectively. Results confirm that the proposed methodology is complete and effective. It is demonstrated that the developed wearable system allows for a reliable assessment of human gait spatio-temporal parameters. Therefore, the goal of this paper is threefold. The first goal is to present and define structured Protocol Design Guidelines, where the related setup is implemented for the validation of wearable IMU systems particularly dedicated to GA and gait monitoring. The second goal is to apply these Protocol Design Guidelines to a case study in order to verify their feasibility, user-friendliness, and efficacy. The third goal is the validation of our biomechanical kinematic model with the gold standard reference.

This study aimed to explore the application of infrared thermography in combination with ambulatory wearable monitoring of temperature and relative humidity, to assess the residual limb-to-liner interface in lower-limb prosthesis users. Five male traumatic transtibial amputees were involved, who reported no problems or discomfort while wearing the prosthesis. A thermal imaging camera was used to measure superficial thermal distribution maps of the stump. A wearable system for recording the temperature and relative humidity in up to four anatomical points was developed, tested in vitro and integrated with the measurement set. The parallel application of an infrared camera and wearable sensors provided complementary information. Four main Regions of Interest were identified on the stump (inferior patella, lateral/medial epicondyles, tibial tuberosity), with good inter-subject repeatability. An average increase of 20% in hot areas (P < 0.05) is shown after walking compared to resting conditions. The sensors inside the cuff did not provoke any discomfort during recordings and provide an inside of the thermal exchanges while walking and recording the temperature increase (a regime value is ~+1.1 ± 0.7 °C) and a more significant one (~+4.1 ± 2.3%) in humidity because of the sweat produced. This study has also begun the development of a reference data set for optimal socket/liner-stump construction.

A model based on a harmonic oscillator describing human walking and balance with the sinusoidal trajectory of the center of mass of a subject during gait is presented. This model allows overcoming the traditional drift due to the double integration of raw acceleration data. The protocol uses a single 3D accelerometer worn at the pelvis level. The system computes the spatiotemporal gait and balance parameters when the subject is walking with or without aids. An incremental methodological approach is proposed and followed in the implementation and accuracy assessment. Eleven healthy subjects have participated to the study performing 6 trials over a fixed linear walking path at a self-selected speed. For reference, the protocol has imposed the execution of 52 steps whose length has been fixed at 60 cm. Different processing methods have been implemented and tested. The model identifies steps, walking time, and stepping frequency with an excellent reliability (absolute percentage accuracy error < 5%). When the information about the expected step length is given to the model, the percentage error in the measure of walking distance and speed is 3.25%. Without this input, this error rises to 4.95%, while for the anthropometric method is 3.68%.