An interventional study of Full/High Tech Telerehabilitation decision support system and Basic/Low Tech Telerehabilitation decision support system in Stroke, Mild Cognitive Impairment and Vestibular Diseases, sponsored by University College, London. Not yet recruiting at 5 sites in 5 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by University College, London · Not applicable, Interventional, and Treatment
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 multisite randomised control trial (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims to (i) determine the system's safety, acceptability, and feasibility explore effectiveness 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 (ii) assess if balance function, gait, cognitive function, balance confidence, and wellbeing can improve more compared to standard intervention and (iii) provide preliminary data for a definitive randomised controlled trial.
This study involves human participants, and each clinical site has applied for appropriate ethical approval.
This is an assessor-blinded (researchers assessing the participants will not know what study group participants will be in), randomised (participants will join different study groups randomly) controlled study. Participants will be randomised using an online platform to undergo a home-based exercise programmes, into either the intervention group (IG) or control group (CG). Participants will not be able to choose their preferred group and must be willing to participate in the assigned group.
All study participants will attend two sessions at UCL. The first assessment will be within one week prior to starting the programme, and the second will be within one week of completing the programme. Participants will be asked to complete a questionnaire set, walking/balance tests and a cognitive test.
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.
Intervention Group (IG): TeleRehab DSS The intervention (TeleRehaB DSS) group participants will be visited by a research team member to install the TeleRehab DSS system in their home and taught how to use the system, with a practice session. The system comprises a depth camera, lightweight augmented reality headset that displays the hologram, body-worn sensors that record movements and a heart rate sensor. Participants will be required to wear all the equipment when performing the prescribed exercises. A demo-video (including equipment and hologram) is available at www.holobalance.eu. Exercise progressions will be suggested by the AI-supported TeleRehaB DSS and approved by the clinicians at weeks 3, 6, and 9, which will be loaded into the participant's programme. At the end of the study, participants will be invited to take part in an interview to discuss their experience with using the TeleRehab DSS system.
The IG will receive the TeleRehaB DSS supported, prescribed, progressed and delivered intervention. In the TeleRehaB DSS IG, the platform will suggest two possible management strategies, on an individualized 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. The intervention will be delivered as a daily (5 days per week, 12 weeks long) home-based exercise programme prescribed by non-experts (junior physiotherapist without vestibular expertise or non physio) with DSS support and coaching.
Control group (CG):
Control group participants will receive standard balance rehabilitation. Stroke and mild cognitive impairment (MCI) participants will receive the OTAGO home exercise program, while vestibular dysfunction and long covid-19 participants will receive the Meniere's Dizziness Booklet program.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 460 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
5x/week x 9 weeks All TeleRehab DSS components: multisensory balance exercises, AR avatar, real-time feedback, AR gamified activities, sensor-monitored exercise performance and additional cognitive training.
Device: Full/High Tech Telerehabilitation decision support system
5x/week x 9 weeks 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.
Device: Basic/Low Tech Telerehabilitation decision support system
9-week balance exercise programme developed by a research group at University of Otago, New Zealand \[12\]. The OTAGO HEP will be provided to all individuals in the control arm who report falls/are at risk of falls. The OTAGO group participants will receive a pamphlet with instructions for home exercises within the programme, resistance bands and an exercise diary. The OTAGO HEP booklet is available at https://www.livestronger.org.nz/assets/Uploads/acc1162-otago-exercise-manual.pdf
Procedure: OTAGO Home exercise program
Daily x 9 weeks For participants with problems chronic (lasting \>3 months) dizziness/imbalance due to chronic vestibular disorder (affecting the vestibular /balance system) or due to long Covid). The vestibular rehabilitation group participants will receive a booklet with vestibular exercises which have been individualised based on the assessment by the research team member. The exercise booklet is a validated and widely used intervention for vestibular disorder \[17\]. This will be provided to all individuals in the control arm with chronic dizziness/imbalance (\>3 months) without falls/risk of falls (FGA\>22). The booklet has descriptions and diagrams of the exercises and instructions on how to progress these as well as an exercise log, available at: https://www.menieres.org.uk/files/pdfs/balance-retraining-2012.pdf
Procedure: Vestibular rehabilitation program
The TeleRehaB DSS intervention includes balance rehabilitation programme delivered via an augmented reality hologram of a virtual physiotherapist. The system delivers exercises demonstrated via a hologram of the physiotherapist and corrected in real time by the hologram prompts based on performance monitoring via sensors. 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. Exercise progressions will be suggested by the AI-supported TeleRehaB DSS and approved by the clinicians, which will be loaded into the participant's programme.
The basic system does not inlcude exergames, a smartwatch, or a mobile phone for activity tracking. It includes different multisensory balance and gait exercise, cognitive training and real-time feedback from motion sensors. Exercise progressions will be suggested by the AI-supported TeleRehaB DSS and approved by the clinicians, which will be loaded into the participant's programme.
balance rehabilitation program
vestibular rehabilitation and dizziness program
Also known as: Meniere's Dizziness Booklet
Recruitment Rate (acceptability)
percentage of recruited participants that were eligible
Time frame: Baseline (week 0) through to post-intervention at week 10
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 (week 0) through to post-intervention at week 10
Feasibility (protocol deviations/problems)
Incidence of protocol deviation and/or implementation problems reported during the intervention.
Time frame: Baseline (Week 0) through to post-intervention at week 10
Participants experience using the system (usability)
Participants experience using the system (perceived benefits) via via weekly check in on frustration levels, technical troubleshooting and any other usability considerations, as well as during exit interviews for all TeleRehab DSS group completers.
Time frame: weekly and post-intervention at week 10
Adherence to Intervention
percentage of prescribed sessions completed throughout the intervention
Time frame: Week 1 through to completion at week 9
Drop-out rate (acceptability)
Percentage of enrolled participants that were loss to follow-up or drop-outs
Time frame: Baseline (week 0) through to post-intervention at week 10
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 (week 0) & post intervention (Week 10)
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 (week 0) & post intervention (Week 10)
Incremental cost-effectiveness ratio (ICER)
Cost-effectiveness, by dividing the difference in mean QALYs; The Incremental Cost-Effectiveness Ratio (ICER) is calculated as the difference in cost (ΔC) divided by the difference in effectiveness (ΔE) between two interventions. Lower ICER values indicate better cost-effectiveness, while higher values suggest greater cost per unit of effectiveness gained. An intervention is considered cost-effective if its ICER falls below a predefined willingness-to-pay (WTP) threshold
Time frame: 1 year before study to 1 year after the end of the intervention
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 (week 0) & post intervention (Week 10)
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 (week 0) & post intervention (Week 10)
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 (week 0) & post-intervention (Week 10)
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 (week 0) & post intervention (Week 10)
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 (week 0) & post intervention (Week 10)
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, with higher scores indicating worse outcomes (greater anxiety or depression).
Time frame: Baseline (week 0) & post intervention (Week 10)
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 (week 0) & post intervention (Week 10)
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 (week 0) & post intervention (Week 10)
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 (week 0) & post intervention (Week 10)
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 (week 10)
User experience questionnaire (UEQ)
The 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: Baseline (week 0), Week 8 & post intervention (Week 10)
Falls
Falls diary collected (self-reported)
Time frame: collected weekly for the duration of the 9-week intervention and up to 6 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
Time frame: post-intervention (week 10)
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.
Time frame: Baseline (week 0)
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.
Time frame: Baseline (week 0)
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.
Time frame: Baseline (week 0)
Plan to share: Yes — Anonymised data collected willl be analysed, and a Final Study Report prepared. with results published in academic journals and disseminated in relevant clinical/scientific peer-reviewed literature and conferences. 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). The study protocol and study report will be published. Anonymised data will be uploaded to the Zenodo data repository and will be available to other researchers in line with open science principles. 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.
Supporting information: Study protocol, Icf
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University College, London