Validating a method for the estimate of gait spatio-temporal parameters with IMUs data on healthy and impaired people from two clinical centers

Instrumented gait analysis offers objective clinical outcome assessment. To this purpose, inertial measurement units (IMUs) represent nowadays a very effective solution due to their limited cost, ease of use and improved wearability. The aim of this study was to apply a well-documented IMU-based method to measure gait spatio-temporal parameters in a large number of healthy and gait-impaired subjects, and evaluate its robustness and validity across two clinical centers. Overall, the results of this work represent a robust and reliable foundation for the clinical use of the proposed IMU based method for gait parameters estimation

Neoadjuvant plus adjuvant combined or sequenced vemurafenib, cobimetinib and atezolizumab in patients with high-risk, resectable BRAF-mutated and wild-type melanoma: NEO-TIM, a phase II randomized non-comparative study

Background: Following the increased survival of patients with metastatic melanoma thanks to immunotherapy and targeted therapy, neoadjuvant approaches are being investigated to address the unmet needs of unresponsive and intolerant patients. We aim to investigate the efficacy of neoadjuvant plus adjuvant combined or sequenced vemurafenib, cobimetinib and atezolizumab in patients with high-risk, resectable BRAF-mutated and wild-type melanoma. Methods: The study is a phase II, open-label, randomized non-comparative trial in patients with stage IIIB/C/D surgically resectable, BRAF-mutated and wild-type melanoma, with three possible treatments: (1) vemurafenib 960 mg twice daily from day 1 to 42; (2) vemurafenib 720 mg twice daily from day 1 to 42; (3) cobimetinib 60 mg once daily from day 1 to 21 and from day 29 to 42; and (4) atezolizumab 840 mg for two cycles (day 22 and day 43). Patients will be randomized to three different arms: A) BRAF-mutated patients will receive over 6 weeks (1) + (3); B) BRAF-mutated patients will receive over 6 weeks (2) + (3) + (4); C) BRAF wild-type patients will receive over 6 weeks (3) + (4). All patients will also receive atezolizumab 1200 mg every 3 weeks for 17 cycles after surgery and after a second screening period (up to 6 weeks). Discussion: Neoadjuvant therapy for regional metastases may improve operability and outcomes and facilitate the identification of biomarkers that can guide further lines of treatment. Patients with clinical stage III melanoma may especially benefit from neoadjuvant treatment, as the outcomes of surgery alone are very poor. It is expected that the combination of neoadjuvant and adjuvant treatment may reduce the incidence of relapse and improve survival

Foot clearance estimation during overground walking and vertical obstacle passing using shank-mounted MIMUs in healthy and pathological subjects

A method for assessing maximum foot clearance (maxFCl) during overground walking and obstacle passing using magnetic and inertial measurement units (MIMUs) placed above the malleoli is proposed and validated. The method precision and accuracy were evaluated using a stereo-photogrammetric system as a gold standard. The proposed method was applied to the data obtained from the gait of both healthy subjects and patients with various abnormal gaits. First, an optimally filtered direct and reverse integration (OFDRI) was used for each gait cycle to determine the gait velocity. Then, the effect of an additional OFDRI or a simple DRI approach for obtaining vertical foot displacement was explored. The results showed that the mean absolute errors associated to the maxFCl estimates were about 10% of its range of variation for the healthy and pathological subjects during overground walking. An accurate estimate of the maxFCl during obstacle passing was reached (mean absolute errors less than 5%). Additional testing on gait at various gait speed and on a greater number of subjects should be carried out to fully validate the MIMU-based maxFCl estimates

Identification of multiple U-turns using IMUs: Comparative assessment of three methods

4reservedmixedBertoli, M.; Cereatti, A.; Trojaniello, D.; Della Croce, U.Bertoli, M.; Cereatti, A.; Trojaniello, D.; Della Croce, U

The identification of multiple U-turns in gait : comparison of four trunk IMU-based methods

The identification of turns during walking allows for the segmentation into straight and turn walking bouts. Several IMU-based methods were developed to this purpose, however many of them were tested on specific subject population. In this study, we tested four methods for the identification of turns in walking tasks with multiple U-turns that did not exploit any a-priori knowledge of the turn occurrences. We evaluated their robustness by recording IMU data on healthy and pathological subjects (healthy elderly, stroke survivors, patients with Parkinson disease and choreic patients) walking at two different speeds along a closed loop formed by straight bouts and U-turns. Overall, all methods identified correctly the totality of the U-turns when elderly and Parkinsonian patients were analyzed. When stroke survivors and choreic patients were analyzed, U-turns were either missed or erroneously detected in a limited number of cases. The only method using the magnetometer signals was the best performing, highlighting the usefulness of the magnetometer when turns are being investigated