Telerehabilitation of Balance Clinical and Economic Decision Support System
NCT ID: NCT06534164
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
460 participants
INTERVENTIONAL
2025-09-01
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Telerehabilitation Decision Support System: Pilot Testing Protocol
NCT07079787
Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls
NCT04053829
A Low-Cost Balance Training Platform Using Augmented Reality in Neurorehabilitation: a Usability Study
NCT06627387
Telerehabilitation, Core Stability Exercises and Hereditary Ataxia (TRCore-ataxia)
NCT06152133
Effectiveness of Telerehabilitation in Balance Training Program
NCT06210828
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
1. OTAGO Home Exercise Programme (HEP), a balance exercise programme developed by a research group at University of Otago, New Zealand. 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
2. Vestibular rehabilitation programme - 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. 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Full/High-tech TeleRehab DSS
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.
Full/High Tech Telerehabilitation decision support system
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.
Basic/Low-tech TeleRehab DSS
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.
Basic/Low Tech Telerehabilitation decision support system
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.
OTAGO Home Exercise programme
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
OTAGO Home exercise program
balance rehabilitation program
Vestibular rehabilitation programme
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
Vestibular rehabilitation program
vestibular rehabilitation and dizziness program
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Full/High Tech Telerehabilitation decision support system
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.
Basic/Low Tech Telerehabilitation decision support system
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.
OTAGO Home exercise program
balance rehabilitation program
Vestibular rehabilitation program
vestibular rehabilitation and dizziness program
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* community dwelling able to walk 500-m independently or with a stick
* Depression subscale on Hospital Anxiety and Depression Scale \<10/21 (14-item questionnaire)
* No significant visual impairment (as self-reported by participants)
* Willing to comply with study procedures, proposed training and testing regime
* With capacity to consent
* No acute musculoskeletal or other injuries that would prevent participation in a structured exercise program
* Is not currently, and has not in the past 8-weeks received any falls/balance/vestibular and/or cognitive rehabilitation.
* Does not any implanted medical devices or a cardiac pacemaker.
* Does not have any other co-existing neurological conditions (ie. Multiple sclerosis, Parkinson's disease, neuropathy etc.)
* Does not have any language or communication deficits impairing their ability to communicate and/or express their thoughts.
* Has at least one functional hand for grip function and computer use.
* Fulfilling all of the criteria from one of the below sub-groups
STROKE COHORT who will fulfil the additional criteria:
* Individuals with diagnosis of focal ischaemic or haemorrhagic stroke, as confirmed by a clinical letter.
* Onset \>/= 3 months prior to study.
* Montreal Cognitive Assessment (MoCA) score n \>/=23
* At risk of falls (i.e. Functional Gait Assessment FGA score \</=22/30; FGA is a validated quick balance task assessment) AND/OR having experienced a fall(s) in the last 12 months
MCI COHORT who will fulfil the additional criteria:
* Individuals with new or existing formal diagnosis of MCI, according to the International Classification of Disease 10 (ICD10) , as confirmed by a clinical letter.
* At risk of falls (FGA \</= 22/30) AND/OR having experienced a fall(s) in the last 12 months.
VESTIBULAR COHORT who will fulfill the additional criteria
* Montreal Cognitive Assessment (MoCA) score n \>/=23
* Individuals with a diagnosis of a vestibular disorder (peripheral and/or mixed peripheral and central):
* Peripheral vestibular disorder in which the balance problem lies in the vestibular/balance system within the inner ear.
* Mixed vestibular disorder in which the balance problem lies in the vestibular/balance system within the inner ear (peripheral) and involving the nerves or neuronal network in the brain/brainstem responsible for balance (central).
* Chronic dizziness and/or unsteadiness (\>/= 3 months duration) that started at the time or after the vestibular disorder diagnosis.
* Dizziness handicap inventory (DHI \>34) AND/OR At risk of falls (FGA \</=22/30)
LONG COVID-19 COHORT who will fulfill the additional criteria:
* Montreal Cognitive Assessment (MoCA) score n \>/=23
* Individuals with laboratory confirmed diagnosis of Covid (\>/=6 months prior to study onset), as confirmed by a clinical letter.
* Who have been diagnosed with long Covid, as confirmed by a clinical letter.
* Who have chronic dizziness and/or unsteadiness which started after the Covid illness (self-report by the patient; duration \</=3 months).
* Dizziness handicap inventory (DHI \>34) AND/OR At risk of falls (FGA \</=22/30)
* Unable to provide a clinical letter confirming diagnosis.
* For those with stroke, no visual spatial neglect.
Exclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
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
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
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Doris-Eva Bamiou, PhD
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Medical Center Freiberg Neurocenter (UKLFR)
Freiberg, , 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 (KMCH)
Bangkok, , Thailand
University College London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Andreia Pimenta
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Functional Gait Assessment
mini Balance Evaluation Systems Test
Montreal Cognitive Assessment (MoCA)
TeleRehab Website
Rapid Assessment of Physical Activity
Dizziness Handicap Inventory
Activities Specific Balance Confidence Scale
Hospital Anxiety and Depression Scale
Fatigue Severity Scale
Warwick Edingburgh Mental Wellbeing Scale
Situational Characteristics Questionnaire (SCQ)
System Usability Scale
User Experience Questionnaire
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
101057747
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UCLondon 101057747
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.