Telerehabilitation of Balance Clinical and Economic Decision Support System
Trial ID: NCT06534164
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-09-01
Completion date: 2026-08-31
Sponsor: University College, London
Collaborators: National and Kapodistrian University of Athens; University Medical Center Freiburg; King Chulalongkorn Memorial Hospital; Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira; Institute of Communications and Computer Systems, Athens, Greece; University of Ioannina; Vilabs; BioIRC; Activage; Institue De Desenvolvimento De Novas Technologiassociacao; Quantitas SRL; Instituto para o Desenvolvimento e Inovação; BRIDG
Conditions: Stroke; Mild Cognitive Impairment; Vestibular Diseases; Long Covid19
Interventions: Full/High Tech Telerehabilitation decision support system; Basic/Low Tech Telerehabilitation decision support system; OTAGO Home exercise program; Vestibular rehabilitation program
Locations: University Medical Center Freiberg Neurocenter (UKLFR); National and Kapodistrian University of Athens; Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira; King Chulalongeorn Memorial Hospital (KMCH); University College London
Countries: Germany; Greece; Portugal; Thailand; United Kingdom
Enrollment: 460
Age range: 40 Years - 80 Years
Sex: ALL

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.

Eligibility criteria:
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 \</=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) , 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

* 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 \</=22/30)

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 \</=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.

Outcomes:
Recruitment Rate (acceptability); Incidence of Treatment-Emergent Adverse Events (safety); Feasibility (protocol deviations/problems); Participants experience using the system (usability); Adherence to Intervention; Drop-out rate (acceptability)