Telerehabilitation of Balance Clinical and Economic Decision Support System
TeleRehab DSS
2 other identifiers
interventional
460
5 countries
5
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Sep 2025
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2024
CompletedFirst Posted
Study publicly available on registry
August 2, 2024
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
July 10, 2025
July 1, 2025
10 months
July 29, 2024
July 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Recruitment Rate (acceptability)
percentage of recruited participants that were eligible
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.
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.
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.
weekly and post-intervention at week 10
Adherence to Intervention
percentage of prescribed sessions completed throughout the intervention
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
Baseline (week 0) through to post-intervention at week 10
Secondary Outcomes (19)
Mini Balance Evaluation Systems Test (Mini-BESTest)
Baseline (week 0) & post intervention (Week 10)
Functional Gait Assessment (FGA)
Baseline (week 0) & post intervention (Week 10)
Incremental cost-effectiveness ratio (ICER)
1 year before study to 1 year after the end of the intervention
EuroQol five dimensional descriptive system (EQ-5D-5L)
Baseline (week 0) & post intervention (Week 10)
Montreal Cognitive Assessment (MoCA)
Baseline (week 0) & post intervention (Week 10)
- +14 more secondary outcomes
Study Arms (4)
Full/High-tech TeleRehab DSS
EXPERIMENTAL5x/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.
Basic/Low-tech TeleRehab DSS
EXPERIMENTAL5x/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.
OTAGO Home Exercise programme
ACTIVE COMPARATOR9-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
Vestibular rehabilitation programme
ACTIVE COMPARATORDaily 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
Interventions
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.
vestibular rehabilitation and dizziness program
Eligibility Criteria
You may qualify if:
- Age 40-80 years
- 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.
- +19 more criteria
You may not qualify if:
- 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
- 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
- Unable to provide a clinical letter confirming diagnosis.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- National and Kapodistrian University of Athenscollaborator
- University Medical Center Freiburgcollaborator
- King Chulalongkorn Memorial Hospitalcollaborator
- Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeiracollaborator
- Institute of Communications and Computer Systems, Athens, Greececollaborator
- University of Ioanninacollaborator
- Vilabscollaborator
- BioIRCcollaborator
- Activagecollaborator
- Institue De Desenvolvimento De Novas Technologiassociacaocollaborator
- Quantitas SRLcollaborator
- Instituto para o Desenvolvimento e Inovaçãocollaborator
- BRIDGcollaborator
Study Sites (5)
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, WC1N 3BG, United Kingdom
Related Links
- EQ-5D-5L
- 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Doris-Eva Bamiou, PhD
University College, London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will be blinded to which study arm participants have been allocated to. Due to the nature of the study, investigator's and participants cannot be blinded, althouhg intervention group participants will be blinded as to which intervention (High vs. Low tech) they have been allocated to.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2024
First Posted
August 2, 2024
Study Start
September 1, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
July 10, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 20 years after the research study has ended; Nov 2025 - Nov 2045
- Access Criteria
- 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.
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.