A functionality, safety and validity study of innovative REACH devices

Introduction Ageing is one of the major challenges affecting health-care systems in developed countries. Sedentary lifestyle is common among elderlies and associated with increased mortality, morbidity and decreased autonomy and quality of life. Accordingly, one cornerstone of the REACH project is to promote physical activity. In particular, in touchpoint cluster 1, a personal mobility device integrating a monitoring solution will be created. This study aims to assess the safety, validity and functionality of devices that may be adapted for this purpose: a rehabilitation equipment produced by Alreh Medical, the iStander activ, its software, Neuroforma, and a sensor, the Fitbit Charge 2. Methods Patients hospitalized at the geriatric division of Geneva University Hospitals and healthy controls were recruited. Patients were randomly assigned to train their transfers with the iStander activ and its associated- software, neuroforma, or according to the Standard Medical Care during 4 consecutive days over 30 minutes. Healthy controls trained their transfers using the iStander activ and Neuroforma. Exercises were monitored by the Fitbit Charge 2. Safety was assessed by free reporting, functionality by the NASA Task-Load Index (NTLI) and by free commenting by patients and care-givers. Differences between heart rate values measured by the Fitbit device and those measured by care-givers assessed the accuracy of heart rate measurement by the Fitbit device. Results No major safety issues were reported. Functionality assessment by care-givers and patients concluded that the iStander in its current form is not properly suited for transfer training in this use case but would be more effective in situations requiring strong trunk stabilization such as upper limb exercises or lower limb exercises for patients suffering from severe lower-limb paresia. The verticalisation force was reported as too strong and the range of possible movements too limited. Some patients reported not being interested in associated videogame interface and suggestions of design improvements were made. The ease-of-use and comfort of the Fitbit were appreciated but the wristband was reported as difficult to adapt. The comparison of heart rate values raised concerns about the potential use of the Fitbit Charge 2 as a heart rate measurement tool for REACH. Conclusion: Our study, though exploratory, provides important insights for the development of the touchpoint cluster 1 personal mobility device.