Status:
NOT_YET_RECRUITING
Telerehabilitation of Balance Clinical and Economic Decision Support System
Lead Sponsor:
University College, London
Collaborating Sponsors:
National and Kapodistrian University of Athens
University Medical Center Freiburg
Conditions:
Stroke
Mild Cognitive Impairment
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief 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 physioth...
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) control...
Eligibility Criteria
Inclusion
- ALL PARTICIPANT
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT06534164
Start Date
September 1 2025
End Date
August 31 2026
Last Update
July 10 2025
Active Locations (5)
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1
University Medical Center Freiberg Neurocenter (UKLFR)
Freiberg, Germany
2
National and Kapodistrian University of Athens
Athens, Greece
3
Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira
Madeirã, Portugal
4
King Chulalongeorn Memorial Hospital (KMCH)
Bangkok, Thailand