Effects of a Rehabilitation Program Using a Patient-Personalized Exergame on Fear of Falling and Risk of Falls in Vulnerable Older Adults: Protocol for a Randomized Controlled Group Study.

Background: Older adults often experience physical, sensory, and cognitive decline. Therefore, they have a high risk of falls, which leads to severe health and psychological consequences and can induce fear of falling. Rehabilitation programs using exergames to prevent falls are being increasingly studied. Medimoov is a movement-based patient-personalized exergame for rehabilitation in older adults. A preliminary study showed that its use may influence functional ability and motivation. Most existing studies that evaluate the use of exergames do not involve an appropriate control group and do not focus on patient-personalized exergames.

Objective: This study aims to evaluate the effects of Medimoov on risk of falls and fear of falling in older adults compared with standard psychomotor rehabilitation.

Methods: This is a serial, comparative, randomized controlled group study. Both groups (n=25 in each) will receive psychomotor rehabilitation care. However, the methods of delivery will be different; one group will be exposed to the Medimoov exergame platform, and the other only to traditional means of psychomotor rehabilitation. The selection criteria will be (1) age of 65 years or older, (2) ability to answer a questionnaire, (3) ability to stand in a bipedal position for at least 1 minute, (4) score of 13 or greater on the Short Fall Efficacy Scale, and (5) stable medical condition. An evaluation will be made prior to starting the intervention, after 4 weeks of intervention, and at the end of the intervention (after 8 weeks), and it will focus on (1) risk of falls, (2) fear of falling, and (3) cognitive evaluations. Physical activity outside the session will also be assessed by actimetry. The outcome assessment will be performed according to intention-to-treat analysis.

Results: The protocol (2019-11-22) has been approved by the Comité de Protection des Personnes Nord-Ouest I-Université de Rouen (2019-A00395-52), which is part of the French national ethical committee. The study received funding in February 2020. As of October 2020 (submission date), and due to the context of the COVID-19 pandemic, a total of 10 participants out of 50 had been enrolled in the study. The projected date for the end of the data collection is December 2021. Data analyses have not been started yet, and publication of the results is expected for Spring 2022.

Conclusions: The effects of psychomotor rehabilitation using the Medimoov exergame platform on the risk and fear of falls will be evaluated. This pilot study will be the basis for larger trials.

Trial Registration: ClinicalTrials.gov NCT04134988; https://clinicaltrials.gov/ct2/show/NCT04134988.

International Registered Report Identifier (irrid): DERR1-10.2196/24665.