Clinical trial NCT06534164: Telerehabilitation of Balance Clinical and Economic Decision Support System
Official title: Telerehabilitation of Balance Clinical and Economic Decision Support System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Mild Cognitive Impairment
Vestibular Diseases
Long Covid19
Keywords: vestibular
rehabilitation
falls
balance
exercise
artificial intelligence
telerehabilitation
physiotherapy
cognitive
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: University Medical Center Freiburg
name: King Chulalongkorn Memorial Hospital
name: Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira
name: Institute of Communications and Computer Systems, Athens, Greece
name: University of Ioannina
name: Vilabs
name: BioIRC
name: Activage
name: Institue De Desenvolvimento De Novas Technologiassociacao
name: Quantitas SRL
name: Instituto para o Desenvolvimento e Inovação
name: BRIDG
First posted: 2024-08-02
Enrollment: 520
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an assessor-blinded, parallel, randomised controlled study. Participants will be block randomised by condition (stroke, MCI, long covid-19, vestibular disorders) using an online platform into either the intervention group (IG) or control group (CG). Within the IG, participants will be randomised into one of two groups; 1) High tech TeleRehab DSS system, 2) Low tech TeleRehab DSS system. Participants will not be able to choose their preferred group and must be willing to participate in the assigned group.
Primary purpose: TREATMENT

Brief summary: Exercise has been shown to improve balance in older adults who are at risk for falls or those that have fallen in the past year. Exercises are often provided as a standardised home exercise programme (provided as a pamphlet) for people to follow independently at home with routine check-ups. Alternatively, these exercises are provided in a community setting (such as a falls clinic) where exercises are done in groups supervised by a rehabilitation team \[1\]-\[6\]. Many exercise programmes only provide basic balance and strengthening 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 to report balance problems. All such individuals may depend more on vision for balance and may have unpleasant feelings of blurred vision and/or unsteadiness when walking \[7\]-\[9\]. Customised exercise programmes can reduce these symptoms and have shown promise in reducing symptoms and improving balance \[10\].

Although customised exercises may offer additional benefits compared with traditional programmes, they are costly to run and require many face-to-face appointments with a physiotherapist. Recent advances in technology have allowed a computerised exercise programme 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 via a lightweight headset \[11\]. This enables us to provide a personalised, interactive programme that allows the physiotherapist to monitor the participant's progress and change the exercises without visiting the participant's physiotherapist \[11\].

This study follows the successfully completed HOLOBalance project which was funded by the EU Horizon 2020 scheme\[11\]. 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/ \[11\]. 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 \[11\].

This study (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims to explore effectiveness (including cost) 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 review treatment result: risk of falls, balance, memory function - based on clinical tests and real-life sensor 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 for appropriate ethical approval.

Detailed description: 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-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 \[17\]. 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

Eligibility criteria: 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.

Primary outcomes:
measure: EuroQol five dimensional descriptive system (EQ-5D-5L)
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: 1 year before study to 1 year after the end of the intervention
measure: Functional Gait Assessment (FGA)
timeFrame: Baseline (week 0) & post intervention (Week 14)
Secondary outcomes:
measure: Mini Balance Evaluation Systems Test (Mini-BESTest)
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: Rapid Assessment of Physical Activity (RAPA)
timeFrame: Baseline (week 0), Week 8 & post intervention (Week 14)
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: The Activities-specific balance confidence scale (ABC)
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: The Hospital Anxiety and Depression Scale (HADS-d) depression subscale
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: Fatigue Severity Scale (FFS)
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: Warwick-Edingburgh Mental Wellbeing Scale (WEMWBS)
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: Situational Vertigo Questionnaire(SVQ):
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: The system Usability Scale (SUS)
timeFrame: post-intervention (week 14)
measure: User experience questionnaire (UEQ)
timeFrame: Baseline (week 0), Week 8 & post intervention (Week 14)
measure: Falls
timeFrame: collected weekly for duration of 12-week intervention and up to 12 months after completing the intervention
measure: System performance
timeFrame: post-intervention (week 14)
measure: eHealth Literacy Assessment (eHEALS)
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: The Senior technology acceptance & adoption model (STAM)
timeFrame: Baseline (week 0) & post intervention (Week 14)
measure: Mobile Device Proficiency Questionnaire - short (MDPQ-s)
timeFrame: Baseline (week 0) & post intervention (Week 14)
Other outcomes:
Locations:
city: Freiberg
country: Germany
facility: University Medical Center Freiberg Neurocenter (UKLFR)
city: Athen
country: Greece
facility: National and Kapodistrian University of Athens
city: Madeirã
country: Portugal
facility: Instituto para o Desenvolvimento e Inovação
city: Madeirã
country: Portugal
facility: Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira
city: Bangkok
country: Thailand
facility: King Chulalongeorn Memorial Hospital (KMCH)
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: University College, London
name: Doris-Eva Bamiou, PhD
role: PRINCIPAL_INVESTIGATOR
References: