JMIR Publications

ABSTRACT

The aging of the population leads to an increase in disability implying a strong effect on health care systems and the lives of caregivers. As example, stroke is a major cause of very common disease and is one of the leading causes of disability in older adults. Rehabilitation is the most effective intervention to counteract patient disability and at the same time reduce the burden of caregivers. In particular, repetitive and task-specific training seems to be the most effective intervention in post-stroke rehabilitation. Virtual reality (VR) is a very useful tool to provide this type of intervention making it fun through gamification. This paper aimed to present the protocol that will be used to evaluate the acceptability and usability of an upper limb rehabilitation solution based on VR. In fact, the RecoveryFun tele-rehabilitation system consists of a VR headset, a wearable sensor, a caregiver application and a clinical platform. A total of 15 patients fulfilling the inclusion and exclusion criteria will be recruited in 3 recruitment centres, 5 from each site. The system will be given to patients and they will be free to use it when they prefer at their home, with or without caregiver help, following the clinical session set by the physiotherapist. At least 20 minutes of use per week is requested. The physical therapist will be able to remotely monitor the progress of the therapy and increase the difficulty and repetitions of the exergames, also considering patient’s fatigue and stress levels. The system will be held by the patients for 4 weeks, and there will be several meetings and phone call supervision by the therapist. The main dimensions investigated will be system usability and acceptability. Upper limb function and patient’s quality of file as well as caregiver’s perceived stress will also be assessed as secondary outcomes. The trial will start in May 2024 and end in June 2024. The aim of the study is to propose and evaluate a new telemedicine system that would allow greater adherence to therapy without moving from home, reducing the burden on the caregiver. The system could also be used in rehabilitation centres by complementing traditional rehabilitation. Finally, with the calibration system enabling the therapist to create customized clinical sessions for the patient, the system could be versatile and fun for a wide range of patients. The study was approved by the Ethics Committee of the IRCCS INRCA. It was recorded in ClinicalTrials.gov on the number NCT06640452. The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings.