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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Rate (acceptability)
Timeframe: Baseline (week 0) through to post-intervention at week 10
2
Incidence of Treatment-Emergent Adverse Events (safety)
Timeframe: Baseline (week 0) through to post-intervention at week 10
3
Feasibility (protocol deviations/problems)
Timeframe: Baseline (Week 0) through to post-intervention at week 10
4
Participants experience using the system (usability)
Timeframe: weekly and post-intervention at week 10
5
Adherence to Intervention
Timeframe: Week 1 through to completion at week 9
6
Drop-out rate (acceptability)
Timeframe: Baseline (week 0) through to post-intervention at week 10