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 pilot testing of a multisite randomised control trial (TeleRehab DSS, short forTeleRehabilitation Decision Support System) aims to investigating the usability andfeasibility among a smaller sample population at each clinical site, identifying anytechnical bugs, and/or clinical procedural flaws to be remedied before delivery of thefull-scale RCT.
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.
Device: TeleRehab DSS Pilot Test
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
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,
Freiburg im Breisgau 2925177, 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
Bangkok 1609350, Thailand
University College London
London 2643743, United Kingdom
Doris-Eva Bamiou, PhD
+44 07813716768
d.bamiou@ucl.ac.uk
Brooke Nairn, MSc.
+44 07538640838
b.nairn@ucl.ac.uk
Doris-Eva Bamiou, PhD, Principal Investigator
University College, London