Exercise has been shown to improve balance in older adults who are at risk for falls orthose that have fallen in the past year. Exercises are often provided as a standardisedhome exercise programme (provided as a pamphlet) for people to follow independently athome with routine check-ups. Alternatively, these exercises are provided in a communitysetting (such as a falls clinic) where exercises are done in groups supervised by arehabilitation team [1]-[6]. Many exercise programmes only provide basic balance andstrengthening exercises to help reduce falls [2]-[5].Older adults, or patients with stroke or mild memory problems (mild cognitive impairment,MCI) may be at higher risk of falls [1]-[6]. Individuals with chronic vestibular disorder(which affects the vestibular/balance system long term) or with long Covid are likely toreport balance problems. All such individuals may depend more on vision for balance andmay have unpleasant feelings of blurred vision and/or unsteadiness when walking [7]-[9].Customised exercise programmes can reduce these symptoms and have shown promise inreducing symptoms and improving balance [10].Although customised exercises may offer additional benefits compared with traditionalprogrammes, they are costly to run and require many face-to-face appointments with aphysiotherapist. Recent advances in technology have allowed a computerised exerciseprogramme which can be done at home, and record the performance with body-worn sensors[11]. The programme provides instructions for the exercises and other tasks (for example,games) by projecting a hologram (a three-dimensional image) into a participant's room viaa lightweight headset [11]. This enables us to provide a personalised, interactiveprogramme that allows the physiotherapist to monitor the participant's progress andchange the exercises without visiting the participant's physiotherapist [11].This study follows the successfully completed HOLOBalance project which was funded by theEU Horizon 2020 scheme[11]. 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/ [11]. 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 [11].This study (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims toexplore effectiveness (including cost) 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 review treatmentresult: risk of falls, balance, memory function - based on clinical tests and real-lifesensor information; and collect information about the programme's safety and performance,while determining programme usability.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 (www.sealedenvelope.com) 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 (approximately 2.5 hours duration, including
comfort breaks):
- The questionnaires ask about participants balance and confidence in their ability to
maintain balance in everyday activities, their mood, physical activity levels and
current health-status (approximately 30 minutes).
- The balance/walking tests evaluate the participants balance during different
walking/standing conditions, such as walking with head movement or standing on an
uneven surface (approximately 20 minutes).
- Through a computerised touch screen (digital Montreal cognitive assessment on iPad),
the cognitive tests asses concentration, memory, and multi-tasking ability.
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 TeleRehaB DSS intervention includes HOLOBalance balance rehabilitation programme with
a hologram. It is based upon established, evidence-based multi-sensory rehabilitation
(MSR) protocols that can improve balance control in healthy older adults with exercises
for the balance system if performed regularly over a period of time.
Balance Physiotherapist Hologram (BPH) represents a virtual coach (physiotherapist) which
provides personalised exercises and instructions for home balance training. It also
provides feedback on the individual's performance based on the information received from
body-worn sensors and analysed using EDGE computer processing unit.
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.
The HOLOBalance programme user instructions are available here:
https://holobalance.eu/holobalance-instructions-of-use/
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 [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-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 [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
Device: Full/High Tech Telerehabilitation decision support system
The TeleRehaB DSS intervention includes HOLOBalance 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.
Other Name: HOLOBalance
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 50-80 years
- community dwelling able to walk 500-m independently or with a stick
- Montreal Cognitive Assessment (MOCA score full version > 23, or short version
(verbal only, excluding visual & naming exercises) > 15 (the Montreal Cognitive
Assessment is a validated rapid screening test of language, memory, attention,
visual/spatial, reasoning, orientation skills). The short version will only be
delivered, if during the initial screening call, the clinician is concerned that the
participant will be unable to fulfil the criteria for eligibility)
- 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.
- 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) [14], 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
- 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:
- 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)
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, Germany
National and Kapodistrian University of Athens
Athen, Greece
Instituto para o Desenvolvimento e Inovação
Madeirã, Portugal
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
Doris-Eva Bamiou, PhD
7813716768
d.bamiou@ucl.ac.uk
Brooke Nairn, MSc.
07538640838
b.nairn@ucl.ac.uk
Doris-Eva Bamiou, PhD, Principal Investigator
University College, London