Telerehabilitation in Low-Resource Settings to Improve Postural Balance in Older Adults: A Non-Inferiority Randomised Controlled Clinical Trial Protocol

Several exercise methods with virtual reality devices have been used in treatments for older adults and patients with neurodegenerative diseases, although the mechanisms continue to be elucidated. The aim of this study is to establish the feasibility and effectiveness of a rehabilitation programme using low-cost virtual reality aimed at improving postural balance in older adults. It also seeks to compare low-cost virtual reality under two delivery modalities, telerehabilitation (TR) in elderly centres and face-to-face (FtF) in rehabilitation centres. The study is set up as a non-inferiority two-arm parallel triple-blind randomised controlled clinical trial. Sixteen persons aged 65 to 75-years-old will be included. Eighteen Wii therapy sessions (25-30 min) will be provided through both FtF (control group, = 8) and TR (exposure group, = 8), both with a Nintendo Wii balance board. Data will be collected at baseline (week 0), during the Wii therapy sessions (weeks 2, 4, and 6), and during the follow-up (weeks 8 and 10). The primary outcome will be the area of centre-of-pressure (CoP) sway; secondary outcomes will be medial-lateral and anterior-posterior velocity and standard deviation of CoP; and tertiary outcomes will be clinical measures: single-leg stand, timed up-and-go tests, Barthel Index, and Tinetti's scale. Statistical analyses will be performed using SPSS 20.00 for Windows. The trial adheres to the Declaration of Helsinki and the Chilean laws of rights and duties of the patient and research in humans. Ethical approval was obtained from the Ethics Committee of the University of Talca. Written informed consent will be obtained from participants. In this trial, older adults from a Chilean city with a large rural and underserved population share will be included to test the feasibility and effectiveness of a rehabilitation programme using low-cost VR aimed at improving postural balance to generate evidence to support decision makers generating public health policy. Australian New Zeeland Clinical Trials Registration (ACTRN12621001380886).