NCT07079787 · NOT YET RECRUITING
Telerehabilitation Decision Support System: Pilot Testing Protocol
This trial is testing a home-based telerehabilitation platform called HOLOBalance, which uses a holographic physiotherapist and motion sensors to guide balance and cognitive exercises remotely. Researchers want to know if the system is usable and practical before running a larger study. It enrolls people with stroke, MCI, vestibular disorders, or Long Covid who are at risk of falling. This is a pilot feasibility study — not yet testing whether the intervention works at scale.
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-07-23