The proof-of-concept study, conducted from May 2019 to September 2021, recruited 145 older adults with falls/at risk of falls and middle aged or older individuals with a confirmed diagnosis of a vestibular disorder. Participants were randomised into one of two intervention groups. One group received the HOLOBALANCE/HOLOBOX intervention, i.e. the home-based or the clinic-based intervention, and the other received the standard clinical treatment i.e. the OTAGO Home Exercise Program (HEP) for 8 weeks. All participants were required to undertake a daily exercise program intended to improve their balance, with the program overseen by a physiotherapist.
88% of participants in the HOLOBALANCE interventions achieved at least the minimal clinically significant difference in the Functional Gait Assessment (which is used to assess postural stability and an individual’s ability to perform multiple tasks while walking) scores vs. 55% for participants in the control group. Moreover, 82% of participants in the HOLOBALANCE interventions achieved at least the minimal clinically significant difference in Mini-BESTest (which is a standard balance measure) scores vs. 52% for participants in the control group. Importantly, an average improvement of 25% for FGA and of 36% for Mini-BESTest for those with abnormal scores at baseline and eventually trained with HOLOBOX. It is anticipated that in a client group with greater disability and lower scores, the pre-post treatment change would have been even greater.
Significant pre-post intervention improvements were also noted for some cognitive function tests (visual memory and new learning and visual pattern recognition memory). In addition, 87.5% of participants in the HOLOBALANCE interventions combined achieved at least a 25% improvement in social wellbeing. The high rate of exercise compliance (83%) and the improved balance perceived by 73% of these older adults, and those with vestibular disorders adds further support for the feasibility of the HOLOBALANCE programme implemented in this research. Importantly, the absence of any adverse events during the study related to participant interventions or associated with functioning of the HOLOBALANCE system suggest that the program is safe to use in future studies and clinical applications. Furthermore, both the HOLOBOX and Home-based delivery of the systems appear to be feasible interventions, regardless of the age, sex, or education level of this study population.
Regarding the user experience, the aggregated 94% positive to neural (23% neutral) evaluation of the Attractiveness (i.e. the overall impression of the system) as well as the aggregated 96% positive to neutral (29% neutral) evaluation of the Stimulation (i.e. is it motivating to use the system?). Furthermore, 77% of the participants stated that they would recommend the HOLOBALANCE system to their friends. Also, 59% of the participants indicated that they would definitely (41%) or depending on the price and health insurance coverage (18%) pay for the system if it becomes a medical device in the future.
Despite the huge challenges since the study was performed during the COVID-19 global pandemic, recruitment and retention rates were good, dropout rates were low, and the estimated sample size was achieved. The COVID-19 global pandemic inevitably led to continuous recruitment and intervention uncertainty due to the various government restrictions imposed across the three study sites of Athens, Freiburg, and London and imposed challenges for participants, researchers, and treating therapists. We anticipate that these measures of feasibility would be better under less adverse circumstances. The potential benefit for these multiple factors is therefore immense. All these findings must be confirmed in a further stage 2 randomised controlled trial.
