StrokeTeleRehab DSSNCT07079787
Telerehabilitation Decision Support System: Pilot Testing Protocol
A study testing TeleRehab DSS Pilot Test in people with Stroke and Mild Cognitive Impairment (MCI), run by University College, London at 5 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Mild Cognitive Impairment (MCI), Vestibular Disease
- What is being tested?
- TeleRehab DSS Pilot Test
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 25 Jul 2025to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Outside of the stated age bracket
- Unable to walk independently (even with use of a walking stick)
- MOCA score <23
- Score of 10 or higher on depression subscale of HADS
- Unwilling to comply with study procedures, proposed training and testing regime
- No capacity to consent
Show all 17Show fewer
- Significant visual impairment or homonymous hemianopia (stroke cohort only) (self-reported)
- Orthostatic hypotension or uncontrolled hypertension
- Other neurological problem (e.g. Parkingson's disease, Multiple Sclerosis etc.)
- Language and communication deficits impairing ability to express thoughts (e.g. Aphasia)
- Has participated in a clinical drug trial in the past 6 months.
- Acute musculoskeletal injury that prevents participation in a structured exercise programme (e.g. lower limb fracture).
- Has an implanted medical device or cardiac pacemaker.
- Diagnosis of unstable Meniere's or with more than 4 migraines/month at the time of participating in the study
- Not fulfilling the inclusion criteria for one of the sub-groups (such as criteria for Stroke group, or MCI group, or chronic vestibular disorder group, or long-Covid group), as outlined above.
- Unable to provide a clinical letter confirming diagnosis.
- For those with stroke, no visual spatial neglect.
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Germany1 site
University Medical Center Freiberg Neurocenter (UKLFR), Freiberg,
Freiburg im Breisgau
Isabelle Walz, PhD, nez.ag-maurer@uniklinik-freiburg.de
Greece1 site
National and Kapodistrian University of Athens
Athens
Christos Nikitas, PhD, xnikitas@hotmail.com
Portugal1 site
Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira
Madeirã
Andreia Pimenta, andreia.pimenta@madeira.gov.pt
Thailand1 site
King Chulalongeorn Memorial Hospital
Bangkok
Pattraporn Pajariyapong, pattraporn.p@bin-dai.com
United Kingdom1 site
University College London
London, W10 4DN
Brooke Nairn, MSc, +44 07538640838, brooke.n94@gmail.com
Doris-Eva Bamiou, PhD, d.bamiou@ucl.ac.uk
About this study
Official title: Telerehabilitation of Balance Clinical and Economic Decision Support System
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.
Read the detailed description
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.
- Being tested
- TeleRehab DSS Pilot Test
- Keywords
- vestibular, rehabilitation, falls, balance, exercise, artificial intelligence, teleremedicine, physiotherapy
- Medical subject headings
- Stroke, Cognitive Dysfunction, Vestibular Diseases, Post-Acute COVID-19 Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleRehab DSS Pilot TestDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TeleRehab DSS Pilot Test |
| 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. Receives: Device: TeleRehab DSS Pilot Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment (week 1) through to the last session of Week 3
Recruitment Rate (acceptability)
percentage of recruited participants that were eligible
Measured: 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.
Measured: 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
Measured: Baseline assessment (week 1) through to the last session of week 3
Adherence to Intervention
percentage of prescribed sessions completed throughout the intervention
Measured: 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
Measured: Baseline (week 1) through to last session in week 3
Secondary outcomes (13)
Functional Gait Assessment (FGA)
test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (end of Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start25 Jul 2025 (estimated)
- Primary completion18 Aug 2025 (estimated)
- Study completion29 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Doris-Eva Bamiou, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079787
- Sponsor's protocol ID
- UCLondon17413/002
- Acronym
- TeleRehab DSS
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation of Balance Clinical and Economic Decision Support System
- ClinicalTrials.gov ID
- NCT07079787
- Acronym / sponsor ID
- TeleRehab DSS / UCLondon17413/002
- Keywords
- vestibular, rehabilitation, falls, balance, exercise, artificial intelligence, teleremedicine, physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- 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
- Study start
- 25 Jul 2025 (estimated)
- Primary completion
- 18 Aug 2025 (estimated)
- Study completion
- 29 Aug 2025 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| High-Technology | Active comparator | Device: TeleRehab DSS Pilot TestAll 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 | Device: TeleRehab DSS Pilot TestWith 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Outside of the stated age bracket
- Unable to walk independently (even with use of a walking stick)
- MOCA score <23
- Score of 10 or higher on depression subscale of HADS
- Unwilling to comply with study procedures, proposed training and testing regime
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleRehab DSS Pilot TestParticipants 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 | Device | High-Technology, Low-Technology |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (safety)
Time frame: Baseline assessment (week 1) through to the last session of Week 3
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.
Recruitment Rate (acceptability)
Time frame: Baseline assessment (week 1) through to the last session of Week 3
percentage of recruited participants that were eligible
Feasibility (protocol deviations/problems)
Time frame: Baseline assessment (week 1) through to the last session of week 3
Incidence of protocol deviation and/or implementation problems reported during the intervention.
Participants experience using the system (usability)
Time frame: Baseline assessment (week 1) through to the last session of week 3
Participants experience using the system gathered via qualitative feedback throughout the testing period and post-intervention via exit interviews
Adherence to Intervention
Time frame: Week 1 through to completion at week 3
percentage of prescribed sessions completed throughout the intervention
Drop-out rate (acceptability)
Time frame: Baseline (week 1) through to last session in week 3
Percentage of enrolled participants that were loss to follow-up or drop-outs
13 secondary outcomes
Functional Gait Assessment (FGA)
Time frame: Baseline assessment through to the last session of Week 3
Mini Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Baseline assessment through to the last session of Week 3
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline assessment through to the last session of Week 3
EuroQol five dimensional descriptive system (EQ-5D-5L)
Time frame: Baseline assessment through to the last session of Week 3
Rapid Assessment of Physical Activity (RAPA)
Time frame: Baseline assessment through to the last session of Week 3
Dizziness Handicap Inventory (DHI)
Time frame: Baseline assessment through to the last session of Week 3
The Activities-specific balance confidence scale (ABC)
Time frame: Baseline assessment through to the last session of Week 3
The Hospital Anxiety and Depression Scale (HADS-d) depression subscale
Time frame: Baseline assessment through to the last session of Week 3
Fatigue Severity Scale (FFS)
Time frame: Baseline assessment through to the last session of Week 3
Warwick-Edingburgh Mental Wellbeing Scale (WEMWBS)
Time frame: Baseline assessment through to the last session of Week 3
Situational Vertigo Questionnaire (SVQ)
Time frame: Baseline assessment through to the last session of Week 3
The system Usability Scale (SUS)
Time frame: Post-intervention (end of Week 3)
User experience questionnaire (UEQ)
Time frame: Post-intervention (end of Week 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doris-Eva Bamiou, PhD principal investigator
University College, London
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeleRehab DSS Pilot Test in people with Stroke and Mild Cognitive Impairment (MCI), run by University College, London at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Greece, Portugal, Thailand, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doris-Eva Bamiou, PhD (+44 07813716768, d.bamiou@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (safety) (time frame: Baseline assessment (week 1) through to the last session of Week 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.