TeleRehab DSS Pilot Test: Participants will perform an individualised multisensory balance rehabilitation program via augmented reality, while wearing motion sensors. The program will consist of multisensory balance exercises, cognitive games, and exergames. All participants will perform 2 sessions per week, carried in at each clinical site, over the course of 3-week.s
Study 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 pilot testing of a multisite randomised control trial (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims to investigating the usability and feasibility among a smaller sample population at each clinical site, identifying any technical bugs, and/or clinical procedural flaws to be remedied before delivery of the full-scale RCT.
Eligibility
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of Treatment-Emergent Adverse Events (safety) — Baseline assessment (week 1) through to the last session of Week 3 Participants will be monitored for adverse events during telephone or face-to-face contacts as part of the intervention phase and during follow-up assessments. Any adverse events related to the treatment will be reported via an adverse events form on the system database. Falls diaries will be collected weekly from participants during the intervention and monthly for up to 6 months after completion of the intervention.
Recruitment Rate (acceptability) — Baseline assessment (week 1) through to the last session of Week 3 percentage of recruited participants that were eligible
Feasibility (protocol deviations/problems) — Baseline assessment (week 1) through to the last session of week 3 Incidence of protocol deviation and/or implementation problems reported during the intervention.
Participants experience using the system (usability) — Baseline assessment (week 1) through to the last session of week 3 Participants experience using the system gathered via qualitative feedback throughout the testing period and post-intervention via exit interviews
Adherence to Intervention — Week 1 through to completion at week 3 percentage of prescribed sessions completed throughout the intervention
Drop-out rate (acceptability) — Baseline (week 1) through to last session in week 3 Percentage of enrolled participants that were loss to follow-up or drop-outs
Trial sites (5)
Facility
City
Region
Status
University Medical Center Freiberg Neurocenter (UKLFR), Freiberg,
Freiburg im Breisgau
Germany
National and Kapodistrian University of Athens
Athens
Greece
Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira
Madeira
Portugal
King Chulalongeorn Memorial Hospital
Bangkok
Thailand
University College London
London
United Kingdom
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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