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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
| University Medical Center Freiburg | OTHER |
| King Chulalongkorn Memorial Hospital | OTHER |
| Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Technology | Active Comparator | All TeleRehab DSS components: multisensory balance exercises, AR avatar, real-time feedback, AR gamified activities, sensor-monitored exercise performance, and additional cognitive training. |
|
| Low-Technology | Active Comparator | With depth camera, motion sensors and tablet for multisensory balance exercises, real time feedback, sensor monitored exercise performance and cognitive games. No exergames, no smartwatch, no mobile phone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TeleRehab DSS Pilot Test | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline assessment (week 1) through to the last session of Week 3 |
| Recruitment Rate (acceptability) | percentage of recruited participants that were eligible | 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. | 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 | Baseline assessment (week 1) through to the last session of week 3 |
| Adherence to Intervention | percentage of prescribed sessions completed throughout the intervention | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Gait Assessment (FGA) | test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes). | Baseline assessment through to the last session of Week 3 |
| Mini Balance Evaluation Systems Test (Mini-BESTest) |
| Measure | Description | Time Frame |
|---|---|---|
| Falls | Occurence of falls, and reasoning if any falls took place, self-reported via a falls diary. | collected weekly for the duration of the 3-week 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 |
ALL PARTICIPANT Inclusion Criteria:
STROKE COHORT who will fulfil the additional criteria:
MCI COHORT who will fulfil the additional criteria:
VESTIBULAR COHORT who will fulfill the additional criteria
LONG COVID-19 COHORT who will fulfill the additional criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doris-Eva Bamiou, PhD | Contact | +44 07813716768 | d.bamiou@ucl.ac.uk | |
| Brooke Nairn, MSc. | Contact | +44 07538640838 | b.nairn@ucl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Doris-Eva Bamiou, PhD | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Freiberg Neurocenter (UKLFR), Freiberg, | Freiburg im Breisgau | Germany |
Anonymised data collected will be analysed for improving the system ahead of the full-scale RCT. No participant identifiable data will be included in the final study reports or in the process of dissemination of the study results. The participants will be guided to where they can access the final result publication(s). Anonymised data will be stored securely in an encrypted dashboard and data repository and will be available to other project members and other researchers in line with open science. The research data collected in the course of the study will be retained by UCL and other clinical partners in their capacity as a sponsor for 20 years after the research study has ended. The data will be then securely destroyed.
20 years after the research study has ended; July 2026 - July 2046
All study research team members at all clinical sites will comply with their local requirements with regards to the collection, storage, processing and disclosure of personal information and will uphold the Act's core principles.
The creation of coded, depersonalised data where the participant's identifying information will be replaced by an unrelated sequence of characters will be in place. The digital data collected will be stored in digital format at each clinical sites secure safe haven data platform with encrypted and password protection. The data (hard copies) collected during the study will be stored in the study site file in a securely locked designated cabinet at each clinical site for the duration of the study.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D060825 | Cognitive Dysfunction |
| D015837 | Vestibular Diseases |
| D000094024 | Post-Acute COVID-19 Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| UNKNOWN |
| Institute of Communications and Computer Systems, Athens, Greece | OTHER |
| University of Ioannina | OTHER |
| Vilabs | UNKNOWN |
| BioIRC | UNKNOWN |
| Activage | UNKNOWN |
| Institue De Desenvolvimento De Novas Technologiassociacao | UNKNOWN |
| Quantitas SRL | UNKNOWN |
| Instituto para o Desenvolvimento e Inovação | UNKNOWN |
| BRIDG | UNKNOWN |
In this pilot testing study, participants will be blinded to their allocation gorup, but due to the nature of the study, assessors will not be. Participants will be randomised by condition (stroke, MCI, long covid-19, vestibular disorders) into either the high-technolog or low-technology solution and will carry out the intervention under the supervision of the assessing clinician.
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Participants will be blinded to which study arm participants have been allocated to. Due to the nature of the study, the assessing and treating clinician cannot be blinded.
|
| Baseline (week 1) through to last session in week 3 |
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).
| 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. | 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 | 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. | Baseline assessment through to the last session of Week 3 |
| 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). | 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. | 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). | 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. | 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. | 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. | 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. | 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. | Post-intervention (end of Week 3) |
| post-intervention (week 3) |
| 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 1) |
| 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 1) |
| 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 1) |
| National and Kapodistrian University of Athens | Athens | Greece |
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| Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira | Madeirã | Portugal |
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| King Chulalongeorn Memorial Hospital | Bangkok | Thailand |
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| University College London | London | W10 4DN | United Kingdom |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |