Periodic Reporting for period 2 - HOLOBALANCE (HOLOgrams for personalised virtual coaching and motivation in an ageing population with BALANCE disorders)
Période du rapport: 2019-06-01 au 2021-09-30
Human balance is multifactorial and relies on complex integration of visual, somatosensory, vestibular information and musculoskeletal function. Balance disorders due to age related progressive loss of functioning of sensory information and the inability to control body movements is considered a global epidemic according to the World Health Organization. Balance and gait physiotherapy has been shown to improve postural stability, increase balance confidence and quality of life according to NICE guidelines. Currently there is a total lack of personalized coaching solutions for people with balance disorders to participate in balance and gait physiotherapy and activity promotion.
HOLOBALANCE provides an advanced telerehabilitation solution that addresses the critical health needs of older adults with balance disorders. HOLOBALANCE is a tele-rehabilitation system which provides an individualised, prescribed program to be performed at home. It provides evidence-based exercises, cognitive and other gamified training, physical activity planning, and components that aim to improve motivation and compliance with the activities. The program has been originally designed by a specialist balance physiotherapist and is intended at first instance to be prescribed and regularly reviewed by a non-expert clinician. The system supports this by remotely monitoring task performance and providing the outcomes to the treating physiotherapist to review. The system comprises of a set of CE marked wearables (i.e. accelerometers, sensorized soles, smart bracelet), ambient sensors (motion capture sensor) and a head worn augmented reality display, which provide detailed movement and physiological data for the remote assessment of task performance (prescribed exercises, auditory tasks, and cognitive games).
HOLOBALANCE provides an advanced telerehabilitation solution that addresses the critical health needs of older adults with balance disorders. HOLOBALANCE is a tele-rehabilitation system which provides an individualised, prescribed program to be performed at home. It provides evidence-based exercises, cognitive and other gamified training, physical activity planning, and components that aim to improve motivation and compliance with the activities. The program has been originally designed by a specialist balance physiotherapist and is intended at first instance to be prescribed and regularly reviewed by a non-expert clinician. The system supports this by remotely monitoring task performance and providing the outcomes to the treating physiotherapist to review. The system comprises of a set of CE marked wearables (i.e. accelerometers, sensorized soles, smart bracelet), ambient sensors (motion capture sensor) and a head worn augmented reality display, which provide detailed movement and physiological data for the remote assessment of task performance (prescribed exercises, auditory tasks, and cognitive games).
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.
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.
Our findings, indicate that a moderate dosage multisensory and multifactorial balance rehabilitation program may also have a significant effect on falls risk. Our intervention can contribute to the delay of onset for cognitive impairment and consequently prolong the active life of these older adults, with better quality of life, improved social wellbeing and reduced economic costs for their care. Improvements in social wellbeing are expected to increase participants’ activity levels beyond the end of the clinical trial and help them adopt and preserve a healthy lifestyle which is always the scope of such behavioural change interventions. We further observed successful motivation (assessed with BREQ3 and interviews) achieved through the multilevel motivation that was provided by the new forms of accessible user interaction with the virtual coach, the social networks and the virtual communities.
The main finding from the Bayesian Cost Effectiveness Analysis is that implementing HOLOBALANCE as a personalized virtual coaching and motivation tool in an aging population with balance disorders is not only a cost-effective intervention but also a cost-saving option having higher effectiveness and a lower cost compared to the comparator used in the analysis, i.e. the OTAGO.
HOLOBALANCE is designed to address one of the most commonly encountered problems in exercise programs i.e. compliance. Interactive cognitive-motor training and physical activity planning, have the potential to improve adherence (immediate performance feedback, positive reinforcement, goal-setting, self-monitoring of performance) leading to behavioural change for long-term self-management.
The main finding from the Bayesian Cost Effectiveness Analysis is that implementing HOLOBALANCE as a personalized virtual coaching and motivation tool in an aging population with balance disorders is not only a cost-effective intervention but also a cost-saving option having higher effectiveness and a lower cost compared to the comparator used in the analysis, i.e. the OTAGO.
HOLOBALANCE is designed to address one of the most commonly encountered problems in exercise programs i.e. compliance. Interactive cognitive-motor training and physical activity planning, have the potential to improve adherence (immediate performance feedback, positive reinforcement, goal-setting, self-monitoring of performance) leading to behavioural change for long-term self-management.