NCT06534164 · NOT YET RECRUITING

Telerehabilitation of Balance Clinical and Economic Decision Support System

This trial is testing a hologram-based home balance rehabilitation system called HOLOBalance against standard care for people with balance and fall problems caused by MCI, stroke, vestibular disorders, or long COVID. A physiotherapist hologram guides exercises while sensors monitor performance in real time. This is a Phase NA feasibility and effectiveness study — it is gathering early evidence to inform a larger definitive trial, not a proven treatment.

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 2025-07-10

View full record on ClinicalTrials.gov

All APOE4 clinical trials