This study follows the successfully completed HOLOBalance project which was funded by the EU Horizon 2020 scheme. 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/. 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. This pilot testing of a multisite randomised control trial (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims to investigating the usability and feasibility among a smaller sample population at each clinical site, identifying any technical bugs, and/or clinical procedural flaws to be remedied before delivery of the full-scale RCT.
This is a multi-centre pilot study to test the usability and feasibility of the TeleRehab DSS platform among a sample population across all five clinical sites. Upon meeting the initial inclusion criteria, eligible participants will be scheduled for an appointment to attend the clinic and complete a cognitive assessment (MoCA) and gait assessment (FGA). If a participant is deemed fully eligible, they will proceed with the onboarding process and clinical assessment, including the collection of personal details and a set of health questionnaires. They will then be randomised into either the high-tech or low-tech TeleRehab DSS intervention group. All study participants will attend two sessions weekly over 3-weeks at each clinical site, where they will complete a personalised multisensory balance rehabilitation programme using augmented reality while wearing motion tracking sensors. Clinicians will be present to attend to any technical or clinical queries during completion of the program. At the end of the 3-weeks, the artifical intelligence decision support system will suggest exercise progressions, tracking wether the clinical agrees or disagrees with these suggestions. Participants will receive telephone calls each week to monitor their progress. Participants will also receive remote program reviews at weeks 3, 6 and 9, from a member of the research team to assess and change exercises as required. Participants will be advised to contact the research team by email or by telephone during working hours if they have concerns or questions about their rehabilitation program or the TeleRehab DSS system. The research team will judge whether an additional home visit is required. If a patient does not complete their exercises for three consecutive days, a flag/warning will appear on the patients dashboard as a priority patient to follow up with, within 24 hours. TeleRehaB DSS supported, prescribed, progressed and delivered intervention. In the TeleRehaB DSS IG, the platform will suggest two possible management strategies, on an individualised basis, based on patient profiles and expected benefit: 1)The high-tech, full TeleRehaB DSS with all components of the intervention consisting of TeleRehaB DSS AI-progressed multisensory balance exercises with the use of the AR avatar, real time feedback, AR gamified intervention, sensor monitored exercise performance and additional cognitive training, 2) the low-tech, basic version of TeleRehaB DSS, with depth camera, sensors and tablet - multisensory balance exercises, real time feedback, sensor monitored exercise performance and cognitive games, with no exergames, no smartwatch, and no mobile phone. The clinician can override the TeleRehab DSS group allocation decision if it is deemed unsafe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Participants will perform an individualised multisensory balance rehabilitation program via augmented reality, while wearing motion sensors. The program will consist of multisensory balance exercises, cognitive games, and exergames. All participants will perform 2 sessions per week, carried in at each clinical site, over the course of 3-week.s
University Medical Center Freiberg Neurocenter (UKLFR), Freiberg,
Freiburg im Breisgau, Germany
National and Kapodistrian University of Athens
Athens, Greece
Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira
Madeirã, Portugal
King Chulalongeorn Memorial Hospital
Bangkok, Thailand
University College London
London, United Kingdom
Incidence of Treatment-Emergent Adverse Events (safety)
Participants will be monitored for adverse events during telephone or face-to-face contacts as part of the intervention phase and during follow-up assessments. Any adverse events related to the treatment will be reported via an adverse events form on the system database. Falls diaries will be collected weekly from participants during the intervention and monthly for up to 6 months after completion of the intervention.
Time frame: Baseline assessment (week 1) through to the last session of Week 3
Recruitment Rate (acceptability)
percentage of recruited participants that were eligible
Time frame: Baseline assessment (week 1) through to the last session of Week 3
Feasibility (protocol deviations/problems)
Incidence of protocol deviation and/or implementation problems reported during the intervention.
Time frame: Baseline assessment (week 1) through to the last session of week 3
Participants experience using the system (usability)
Participants experience using the system gathered via qualitative feedback throughout the testing period and post-intervention via exit interviews
Time frame: Baseline assessment (week 1) through to the last session of week 3
Adherence to Intervention
percentage of prescribed sessions completed throughout the intervention
Time frame: Week 1 through to completion at week 3
Drop-out rate (acceptability)
Percentage of enrolled participants that were loss to follow-up or drop-outs
Time frame: Baseline (week 1) through to last session in week 3
Functional Gait Assessment (FGA)
test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes).
Time frame: Baseline assessment through to the last session of Week 3
Mini Balance Evaluation Systems Test (Mini-BESTest)
a 14-item test that assesses dynamic balance, on a scale of 0 (indicating severe balance impairment) to 28 (representing normal balance with a total score of 28 points).
Time frame: Baseline assessment through to the last session of Week 3
Montreal Cognitive Assessment (MoCA)
includes sections on visuospatial/executive function, naming, attention, language, abstraction, memory and orientation to time and place (6 questions) with a scor range from 0-30, with a higher score indicating better cognitive function.
Time frame: Baseline assessment through to the last session of Week 3
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" with a higher score indicating better health-related quality of life
Time frame: Baseline assessment through to the last session of Week 3
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, with a score range 1-7 and a higher score indicating ihgher levels of physical activity.
Time frame: Baseline assessment through to the last session of Week 3
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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).
Time frame: Baseline assessment through to the last session of Week 3
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 .Score range from 0-100 with higher schore indicating greater balance confidence and scores ≤67/100% indicate increased falls risk.
Time frame: Baseline assessment through to the last session of Week 3
The Hospital Anxiety and Depression Scale (HADS-d) depression subscale
14-item scale which assesses non-somatic anxiety (HAD-A) and depression (HAD-D) symptoms. Scores range from 0-21 for each subscale, with higher scores indicating worse outcomes (greater anxiety or depression).
Time frame: Baseline assessment through to the last session of Week 3
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. Sca;e 9-63 with higher score indicating greater fatigue.
Time frame: Baseline assessment through to the last session of Week 3
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. Scale 14-70 with higher score indicating better mental wellbeing.
Time frame: Baseline assessment through to the last session of Week 3
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), with a higher score indicating greater vertigo severity.
Time frame: Baseline assessment through to the last session of Week 3
The system Usability Scale (SUS)
The System Usability Scale (SUS) scale 1-5 rated on 10 aspects, with a total possible score of 0-100, with a higher score indicated better usability.
Time frame: Post-intervention (end of Week 3)
User experience questionnaire (UEQ)
he User Experience Questionnaire (UEQ; scale 1-7 on 26 dimensions of attractiveness, perspicuity, efficiency, dependability, stimulation and novelty with a score range of -3 (worst) to +3 (best) with a higher score indicating a more positive user experience.
Time frame: Post-intervention (end of Week 3)