Telerehabilitation of Balance Clinical and Economic Decision Support System
NCT Number: NCT06534164
Acronym: TeleRehab DSS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Mild Cognitive Impairment|Vestibular Diseases|Long Covid19
Interventions: DEVICE: Full/High Tech Telerehabilitation decision support system|DEVICE: Basic/Low Tech Telerehabilitation decision support system|PROCEDURE: OTAGO Home exercise program|PROCEDURE: Vestibular rehabilitation program
Sponsor: University College, London
Collaborators: National and Kapodistrian University of Athens|University Medical Center Freiburg|King Chulalongkorn Memorial Hospital|Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira|Institute of Communications and Computer Systems, Athens, Greece|University of Ioannina|Vilabs|BioIRC|Activage|Institue De Desenvolvimento De Novas Technologiassociacao|Quantitas SRL|Instituto para o Desenvolvimento e Inovação|BRIDG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 520
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-11-30
Locations: University Medical Center Freiberg Neurocenter (UKLFR), Freiberg, Germany|National and Kapodistrian University of Athens, Athen, Greece|Instituto para o Desenvolvimento e Inovação, Madeirã, Portugal|Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira, Madeirã, Portugal|King Chulalongeorn Memorial Hospital (KMCH), Bangkok, Thailand|University College London, London, WC1N 3BG, United Kingdom

Summary:
Exercise has been shown to improve balance in older adults who are at risk for falls or those that have fallen in the past year. Exercises are often provided as a standardised home exercise programme (provided as a pamphlet) for people to follow independently at home with routine check-ups. Alternatively, these exercises are provided in a community setting (such as a falls clinic) where exercises are done in groups supervised by a rehabilitation team \[1\]-\[6\]. Many exercise programmes only provide basic balance and strengthening exercises to help reduce falls \[2\]-\[5\].

Older adults, or patients with stroke or mild memory problems (mild cognitive impairment, MCI) may be at higher risk of falls \[1\]-\[6\]. Individuals with chronic vestibular disorder (which affects the vestibular/balance system long term) or with long Covid are likely to report balance problems. All such individuals may depend more on vision for balance and may have unpleasant feelings of blurred vision and/or unsteadiness when walking \[7\]-\[9\]. Customised exercise programmes can reduce these symptoms and have shown promise in reducing symptoms and improving balance \[10\].

Although customised exercises may offer additional benefits compared with traditional programmes, they are costly to run and require many face-to-face appointments with a physiotherapist. Recent advances in technology have allowed a computerised exercise programme which can be done at home, and record the performance with body-worn sensors \[11\]. The programme provides instructions for the exercises and other tasks (for example, games) by projecting a hologram (a three-dimensional image) into a participant's room via a lightweight headset \[11\]. This enables us to provide a personalised, interactive programme that allows the physiotherapist to monitor the participant's progress and change the exercises without visiting the participant's physiotherapist \[11\].

This study follows the successfully completed HOLOBalance project which was funded by the EU Horizon 2020 scheme\[11\]. TheHOLOBalance platform delivers exercises demonstrated via a hologram of the physiotherapist and corrected in real time by the hologram prompts based on performance monitoring via sensors. Further information is available at: https://holobalance.eu/ \[11\]. HOLOBalance was developed as a comprehensive rehabilitation protocol for individualised remote (tele)rehabilitation balance physiotherapy programme. It includes different multisensory balance and gait exercises, physical activity and memory training and exergames (video games which are also exercises) to improve balance function in older adults. The system can thus assess and remotely monitor how users are performing the exercises \[11\].

This study (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims to explore effectiveness (including cost) of running such programme in comparison with the current standard care for middle-age/older adults with balance disorders/falls due to MCI, vestibular disorders, stroke or long Covid. This study also aims to review treatment result: risk of falls, balance, memory function - based on clinical tests and real-life sensor information; and collect information about the programme's safety and performance, while determining programme usability.

This study involves human participants, and each clinical site has applied for appropriate ethical approval.

Primary Outcome Measures: EuroQol five dimensional descriptive system (EQ-5D-5L), Measure of quality-adjusted life years (QALYs). EQ-5D-5L is a standardized, valid and reliable simple, generic measure of health status for clinical and economic appraisal. The respondent is asked to rate their health status on these five dimensions from 1 to 5 respectively as no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS (Visual Analogue Scale) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The respondent is asked to mark an X on the scale to indicate "how your health is TODAY". (Reference: EuroQol - a new facility for the measurement of health-related quality of life. Health Policy, 1990. 16(3): p. 199-208.), Baseline (week 0) & post intervention (Week 14)|Incremental cost-effectiveness ratio (ICER), Cost-effectiveness, by dividing the difference in mean QALYs, 1 year before study to 1 year after the end of the intervention|Functional Gait Assessment (FGA), test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes). (Reference: Wrisley DM, Kumar NA. Functional gait assessment: concurrent, discriminative, and predictive validity in community-dwelling older adults. Phys Ther 2010;90:761-73.) From: https://geriatrictoolkit.missouri.edu/FGA/Wrisley-2007-FGA_PTJ_84-10-Appendix.pdf, Baseline (week 0) & post intervention (Week 14)
Secondary Outcome Measures: Mini Balance Evaluation Systems Test (Mini-BESTest), a 14-item test that assesses dynamic balance with a total score of 28 points, 10 minutes). (Reference: Franchignoni, F., et al., Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med, 2010. 42(4): p. 323-31), from: https://www.bestest.us/files/7413/6380/7277/MiniBEST_revised_final_3_8_13.pdf, Baseline (week 0) & post intervention (Week 14)|Montreal Cognitive Assessment (MoCA), includes sections on visuospatial/executive function, naming, attention, language, abstraction, memory and orientation to time and place (6 questions) (15 minutes). (Reference: Nasreddine, Z.S., et al., The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc, 2005. 53(4): p. 695-9). From: https://www.parkinsons.va.gov/resources/MOCA-Test-English.pdf, Baseline (week 0) & post intervention (Week 14)|Rapid Assessment of Physical Activity (RAPA), The 9-item self-administered Rapid Assessment of Physical Activity (RAPA) is a questionnaire that assesses levels of a wide range of physical activity level in adults older than 50 years (5 minutes). (Reference: Topolski TD, LoGerfo J, Patrick DL, et al. The rapid assessment of physical activity (RAPA) among older adults. Prev Chronic Dis 2006;3:A118). From: http://depts.washington.edu/hprc/programs-tools/tools-guides/rapa/, Baseline (week 0), Week 8 & post intervention (Week 14)|Dizziness Handicap Inventory (DHI), The 25-item self-report Dizziness Handicap inventory (DHI) validated questionnaire that assesses functional, emotional and physical domains. Responses are graded 0 (no), 2 (sometimes) or 4 (yes) with higher scores indicating greater impact of dizziness maximum and maximum score of 100 points (15 minutes). (Reference: Jacobson, G.P. \& C.W. Newman, The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg, 1990. 116(4): p. 424-7). From: https://geriatrictoolkit.missouri.edu/vest/Dizziness-Handicap-Inventory.pdf, Baseline (week 0) & post intervention (Week 14)|The Activities-specific balance confidence scale (ABC), The Activities-specific Balance Confidence Scale (ABC) that assesses patient's perceived confidence for 16-activities of daily living without losing balance. Scores ≤67/100% indicate increased falls risk (10 minutes). (Reference: Powell, L.E. and A.M. Myers, The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci, 1995. 50A(1): p. M28-34.). From: https://sites.temple.edu/rtassessment/files/2018/10/Activities-Specific-Balance-Confidence-ABC-Scale.pdf, Baseline (week 0) & post intervention (Week 14)|The Hospital Anxiety and Depression Scale (HADS-d) depression subscale, a 14-item scale which assesses non-somatic anxiety (HAD-A) and depression (HAD-D) symptoms. Scores range from 0-21 for each subscale and a score ≥8 identifies depression and anxiety. (References: Zigmond, A.S. \& R.P. Snaith, The hospital anxiety and depression scale. Acta psychiatrica scandinavica 1983; 67(6): 361-370. Bjelland I, Dahl AA \& Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res 2002; 52(2): 69-77.). From: https://www.svri.org/sites/default/files/attachments/2016-01-13/HADS.pdf, Baseline (week 0) & post intervention (Week 14)|Fatigue Severity Scale (FFS), a 9-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them.

https://www.sralab.org/sites/default/files/2017-06/sleep-Fatigue-Severity-Scale.pdf, Baseline (week 0) & post intervention (Week 14)|Warwick-Edingburgh Mental Wellbeing Scale (WEMWBS), developed to enable the measuring of mental wellbeing in the general population and the evaluation of projects, programmes and policies which aim to improve mental wellbeing. The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible. The scale has been widely used nationally and internationally for monitoring, evaluating projects and programmes and investigating the determinants of mental wellbeing.

https://warwick.ac.uk/fac/sci/med/research/platform/wemwbs/using/howto/, Baseline (week 0) & post intervention (Week 14)|Situational Vertigo Questionnaire(SVQ):, The SVQ is 20-item questionnaire designed to assess discomfort in situations of intense visual salience of visual-vestibular conflict. It was originally developed as a measure of space and motion discomfort. The questions are graded on a scale from 0 (not at all) to 4 (very much). https://neuropt.org/docs/vestibular-sig/situational_vertigo_questionnaireA068B2C6D4D5.pdf?sfvrsn=ef974640_4, Baseline (week 0) & post intervention (Week 14)|The system Usability Scale (SUS), is a simple, ten-item scale giving a global view of subjective assessments of usability.From: https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html, post-intervention (week 14)|User experience questionnaire (UEQ), The scales of the questionnaire cover a comprehensive impression of user experience. Both classical usability aspects (efficiency, perspicuity, dependability) and user experience aspects (originality, stimulation) are measured.. https://www.ueq-online.org/, Baseline (week 0), Week 8 & post intervention (Week 14)|Falls, Falls diary collected (self-reported), collected weekly for duration of 12-week intervention and up to 12 months after completing the intervention|System performance, We will also compare the TeleRehaB DSS predicted versus observed patient outcomes on the EQ-5D-5L, and secondary outcome measures, to assess the system performance, post-intervention (week 14)|eHealth Literacy Assessment (eHEALS), a 10-item likert scale questionnaire that evaluate's patients' skills in finding, evaluating and applying electronic health information. Responses range from 1 (strongly disagree, to 65 (strong agree), with total scores indicating levels of eHealth literacy. This will be used to help validate the AI-model in terms of participant allocation into the high-tech versus low-tech solution., Baseline (week 0) & post intervention (Week 14)|The Senior technology acceptance & adoption model (STAM), is a 38-item questionnaire, with items rated on a 1-10 Likert scale to measure factors influencing technology acceptance among older adults, with a higher scores indicating greater perceived digital literacy., Baseline (week 0) & post intervention (Week 14)|Mobile Device Proficiency Questionnaire - short (MDPQ-s), is a 16-question version of the full MDPQ-16. The MDPQ, its subscales, and the MDPQ-16 were found to be highly reliable and valid measures of mobile device proficiency in a large sample. We conclude that the MDPQ and MDPQ-16 may serve as useful tools for facilitating mobile device training of older adults and measuring mobile device proficiency for research purposes., Baseline (week 0) & post intervention (Week 14)