This study follows the successfully completed HOLOBalance project which was funded by theEU Horizon 2020 scheme. TheHOLOBalance platform delivers exercises demonstrated via ahologram of the physiotherapist and corrected in real time by the hologram prompts basedon performance monitoring via sensors. Further information is available at:https://holobalance.eu/. HOLOBalance was developed as a comprehensive rehabilitationprotocol for individualised remote (tele)rehabilitation balance physiotherapy programme.It includes different multisensory balance and gait exercises, physical activity andmemory training and exergames (video games which are also exercises) to improve balancefunction in older adults. The system can thus assess and remotely monitor how users areperforming the exercises.This multisite randomised control trial (TeleRehab DSS, short for TeleRehabilitationDecision Support System) aims to (i) determine the system's safety, acceptability, andfeasibility explore effectiveness of running such programme in comparison with thecurrent standard care for middle-age/older adults with balance disorders/falls due toMCI, vestibular disorders, stroke or long Covid. This study also aims to (ii) assess ifbalance function, gait, cognitive function, balance confidence, and wellbeing can improvemore compared to standard intervention and (iii) provide preliminary data for adefinitive randomised controlled trial.This study involves human participants, and each clinical site has applied forappropriate 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.
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-m…
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
Device: 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.
Device: 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.
Procedure: OTAGO Home exercise program
balance rehabilitation program
Procedure: Vestibular rehabilitation program
vestibular rehabilitation and dizziness program
Other Name: Meniere's Dizziness Booklet
ALL PARTICIPANT Inclusion Criteria:
- 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.
- Onset >/= 3 months prior to study.
- Montreal Cognitive Assessment (MoCA) score n >/=23
- At risk of falls (i.e. Functional Gait Assessment FGA score
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 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
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
- Dizziness handicap inventory (DHI >34) AND/OR At risk of falls (FGA
Exclusion Criteria:
- 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
- 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.
University Medical Center Freiberg Neurocenter (UKLFR)
Freiberg 2925192, Germany
National and Kapodistrian University of Athens
Athens 264371, Greece
Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira
Madeirã 2266878, Portugal
King Chulalongeorn Memorial Hospital (KMCH)
Bangkok 1609350, Thailand
University College London
London 2643743, United Kingdom
Doris-Eva Bamiou, PhD
7813716768
d.bamiou@ucl.ac.uk
Brooke Nairn, MSc.
7538640838
b.nairn@ucl.ac.uk
Doris-Eva Bamiou, PhD, Principal Investigator
University College, London