Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 29, 2020
Date Accepted: Mar 5, 2021
Effects of a rehabilitation programme using patient-personalised exergame on fear of falling and risk of falls in vulnerable older adults: Protocol of a randomised controlled group study
ABSTRACT
Background:
Older adults have a high risk of falling, which leads to severe health and psychological consequences and can induce fear of falling. Rehabilitation programmes using exergames to prevent falls are increasingly explored. Medimoov is a movement-based patient-personalised exergame for rehabilitation in older adults. A preliminary study showed that its use may influence functional ability and motivation. Most existing studies evaluating the use of exergames do not involve an appropriate control group and do not focus on patient-personalised exergames.
Objective:
Thus, this study aims to evaluate the effects of Medimoov on falling risk and fear of falling in older adults compared with standard psychomotor rehabilitation.
Methods:
This study is an open, randomised controlled trial in parallel groups with blind data collection for the evaluation criterion. Twenty-five older adults per group will be recruited. The selection criteria will be: 1) 65 years of age or older, 2) ability to answer a questionnaire, 3) ability to stand in a bipedal position for at least 1 minute, 4) a score 13 or greater on the Short Fall Efficacy Scale and 5) to be in stable medical condition. Patients will be randomly allocated to two groups, as follows: the intervention group have bi-weekly sessions with Medimoov, the control group will follow the usual rehabilitation programme (bi-weekly psychomotor therapy sessions). Evaluations will be made before the intervention, after 4 weeks of intervention, and at the end of the intervention (after 8 weeks) and will focus on (1) risk of fall, (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 intention-to-treat analysis.
Results:
The protocol (2019-11-22) has been approved by The North-Western I Committee for the Protection of Persons - University of Rouen (#2019-A00395-52), 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 have been enrolled in the study. The projected date for the end of the data collection is December 2021. Data analyses have not started yet and the publication of the results is expected for Spring 2022.
Conclusions:
This study will allow us to evaluate the effect of psychomotor rehabilitation using the Medimoov exergame platform on the fear of falling and risk of falling. If the effects of the Medimoov-assisted rehabilitation programme are shown to be effective for preventing falls and alleviating fear of falling, this pilot study will be the basis for larger trials. Clinical Trial: ClinicalTrials registration number: NCT04134988 (2019/10/22) https://clinicaltrials.gov/ct2/show/NCT04134988.
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