Assessment of the feasibility, safety, tolerability and acceptability of the immersive virtual rehabilitation system (COGMIS) to motor-cognitive training to older people

Abstract

Recent studies show that the use of commercial video games can be just as effective for reducing risk and incidence of falls in older people as conventional physical therapy. However, these non-immersive games are not specifically designed for older people. We believe that an immersive game with cognitive, sensory and motor demands developed specifically for older people can promote better effects than commercial video games. In this context, our group is developing the COGMIS System - Cognitive-Motor Immersive System, a specific tool for cognitive-sensory-motor rehabilitation focusing on postural control training and fall prevention in older people. Objective: The aim of the present study is to develop and analyze the applicability, safety, tolerability and acceptability of COGMIS in young and older people. Method: At the first phase of the study 6 physiotherapists specialized in geriatric physical therapy with at least two years of experience in the field will be recruited. The physiotherapists will test the system and perform a qualitative assessment of applicability through the "Questionnaire and interview for the evaluation of physiotherapists" indicating possible adjustments in the tasks and other functionalities of the game. After the adjustments pointed out by these professionals, the second phase, we will recruit 20 young adults, both gender, aged between 18 to 40 years. Study participants will answer questionnaires for sample characterization, containing sociodemographic data, about use of technology, their perception of the system and the occurrence of possible adverse events. They will then participate in familiarization of the system lasting 10 minutes. The safety data, tolerability and acceptability will be collected after using the COGMIS through the "Virtual Reality Discomfort Questionnaire" and the "Satisfaction Questionnaire" and analyzed to verify the need for adjustments in the game prior to recruiting the older people. After any adjustments, we will start the third phase in which 20 older adults aged between 60 and 80 years old, male and female, without cognitive impairment, no history of falls or vestibular changes will be recruited. The older people will answer questionnaires to the characterization of the sample, and then will participate in a session of 10 minutes of familiarization with the game, and soon after use will respond to the same questionnaires answered by young people to assess safety, tolerability and acceptability. The characterization of the sample will be performed by Montreal Cognitive Scale (young and old), Geriatric Depression Scale (GDS-15, for the elderly only), International Physical Activity Questionnaire (IPAQ, young and old), Charlson Comorbidity Index (young and old),Timed Up and Go Test (TUG for the elderly only) and technology (young and old). Statistical analysis: The sociodemographic data of participants will be presented using descriptive statistics, mean, standard deviation, median, interquartile range, and 95% confidence interval. The answers of the young and older people will be presented in absolute and relative values. Comparison of applicability, safety, tolerability and Acceptability between young and older people will be done through theMann-Whitney test and Chi-square test. Alpha of 0.05 will be adopted as significance level.