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Search / Trial NCT07079787

Telerehabilitation Decision Support System: Pilot Testing Protocol

Launched by UNIVERSITY COLLEGE, LONDON · Jul 18, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Vestibular Rehabilitation Falls Balance Exercise Artificial Intelligence Teleremedicine Physiotherapy

ClinConnect Summary

This clinical trial is testing a new way to help people improve their balance and movement through remote rehabilitation. It uses a special system called HOLOBalance, where exercises are shown by a hologram of a physiotherapist, who also gives real-time feedback based on how well the participant is doing. The goal is to see if this technology is easy to use and practical for people recovering from stroke, mild memory problems (called Mild Cognitive Impairment), balance problems related to inner ear issues (vestibular disease), or long-term symptoms after COVID-19 (long Covid). This study is a smaller pilot to find and fix any issues before a larger trial begins.

People aged 40 to 80 who can walk at least 500 meters on their own or with a walking stick might be eligible. Participants need to have a confirmed diagnosis in one of the groups mentioned, be at risk of falling or have fallen recently, and be able to understand and follow the study instructions. They should not have serious vision problems, other major neurological conditions, or recent physical injuries that stop them from exercising. Participants will be asked to do balance and memory exercises at home using the hologram system, while sensors monitor their performance. The study will help researchers understand how well this remote therapy works and if any technical or practical problems need fixing before wider use.

Gender

ALL

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.

About University College, London

University College London (UCL) is a leading global research institution renowned for its commitment to advancing healthcare through innovative clinical trials. As a prominent sponsor of clinical research, UCL leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous investigations aimed at improving patient outcomes and addressing pressing medical challenges. The institution fosters collaboration among researchers, healthcare professionals, and industry partners, ensuring that its trials adhere to the highest ethical standards and regulatory guidelines. UCL's dedication to translating scientific discoveries into practical applications underscores its role as a vital contributor to the advancement of medical science and public health.

Locations

Athens, , Greece

Freiburg, , Germany

Madeira, , Portugal

Bangkok, , Thailand

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Doris-Eva Bamiou, PhD

Principal Investigator

University College, London

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported