Telerehabilitation Decision Support System: Pilot Testing Protocol

Not Applicable

Not yet recruiting

• Conditions: Stroke; Mild Cognitive Impairment (MCI); Vestibular Disease; Long Covid-19

• Registration Number: NCT07079787
• Lead Sponsor: University College, London

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 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.

Detailed Description

This is a multi-centre pilot study to test the usability and feasibility of the TeleRehab DSS platform among a sample population across all five clinical sites.

Upon meeting the initial inclusion criteria, eligible participants will be scheduled for an appointment to attend the clinic and complete a cognitive assessment (MoCA) and gait assessment (FGA). If a participant is deemed fully eligible, they will proceed with the onboarding process and clinical assessment, including the collection of personal details and a set of health questionnaires. They will then be randomised into either the high-tech or low-tech TeleRehab DSS intervention group.

All study participants will attend two sessions weekly over 3-weeks at each clinical site, where they will complete a personalised multisensory balance rehabilitation programme using augmented reality while wearing motion tracking sensors. Clinicians will be present to attend to any technical or clinical queries during completion of the program. At the end of the 3-weeks, the artifical intelligence decision support system will suggest exercise progressions, tracking wether the clinical agrees or disagrees with these suggestions.

Participants will receive telephone calls each week to monitor their progress. Participants will also receive remote program reviews at weeks 3, 6 and 9, from a member of the research team to assess and change exercises as required. Participants will be advised to contact the research team by email or by telephone during working hours if they have concerns or questions about their rehabilitation program or the TeleRehab DSS system. The research team will judge whether an additional home visit is required. If a patient does not complete their exercises for three consecutive days, a flag/warning will appear on the patients dashboard as a priority patient to follow up with, within 24 hours.

TeleRehaB DSS supported, prescribed, progressed and delivered intervention. In the TeleRehaB DSS IG, the platform will suggest two possible management strategies, on an individualised basis, based on patient profiles and expected benefit: 1)The high-tech, full TeleRehaB DSS with all components of the intervention consisting of TeleRehaB DSS AI-progressed multisensory balance exercises with the use of the AR avatar, real time feedback, AR gamified intervention, sensor monitored exercise performance and additional cognitive training, 2) the low-tech, basic version of TeleRehaB DSS, with depth camera, sensors and tablet - multisensory balance exercises, real time feedback, sensor monitored exercise performance and cognitive games, with no exergames, no smartwatch, and no mobile phone. The clinician can override the TeleRehab DSS group allocation decision if it is deemed unsafe.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Study Start: 2025-07-25
• Primary Completion: 2025-08-18
• Study Completion: 2025-08-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
Adherence to Intervention	Week 1 through to completion at week 3	percentage of prescribed sessions completed throughout the intervention
Recruitment Rate (acceptability)	Baseline assessment (week 1) through to the last session of Week 3	percentage of recruited participants that were eligible
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
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

Secondary Outcome Measures

Name	Time	Method
Functional Gait Assessment (FGA)	Baseline assessment through to the last session of Week 3	test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes).
Mini Balance Evaluation Systems Test (Mini-BESTest)	Baseline assessment through to the last session of Week 3	a 14-item test that assesses dynamic balance, on a scale of 0 (indicating severe balance impairment) to 28 (representing normal balance with a total score of 28 points).
Montreal Cognitive Assessment (MoCA)	Baseline assessment through to the last session of Week 3	includes sections on visuospatial/executive function, naming, attention, language, abstraction, memory and orientation to time and place (6 questions) with a scor range from 0-30, with a higher score indicating better cognitive function.
EuroQol five dimensional descriptive system (EQ-5D-5L)	Baseline assessment through to the last session of Week 3	Measure of quality-adjusted life years (QALYs). EQ-5D-5L is a standardized, valid and reliable simple, generic measure of health status for clinical and economic appraisal. The respondent is asked to rate their health status on these five dimensions from 1 to 5 respectively as no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS (Visual Analogue Scale) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The respondent is asked to mark an X on the scale to indicate "how your health is TODAY" with a higher score indicating better health-related quality of life
Rapid Assessment of Physical Activity (RAPA)	Baseline assessment through to the last session of Week 3	The 9-item self-administered Rapid Assessment of Physical Activity (RAPA) is a questionnaire that assesses levels of a wide range of physical activity level in adults older than 50 years, with a score range 1-7 and a higher score indicating ihgher levels of physical activity.
Dizziness Handicap Inventory (DHI)	Baseline assessment through to the last session of Week 3	The 25-item self-report Dizziness Handicap inventory (DHI) validated questionnaire that assesses functional, emotional and physical domains. Responses are graded 0 (no), 2 (sometimes) or 4 (yes) with higher scores indicating greater impact of dizziness maximum and maximum score of 100 points (15 minutes).
The Activities-specific balance confidence scale (ABC)	Baseline assessment through to the last session of Week 3	The Activities-specific Balance Confidence Scale (ABC) that assesses patient's perceived confidence for 16-activities of daily living without losing balance .Score range from 0-100 with higher schore indicating greater balance confidence and scores ≤67/100% indicate increased falls risk.
The Hospital Anxiety and Depression Scale (HADS-d) depression subscale	Baseline assessment through to the last session of Week 3	14-item scale which assesses non-somatic anxiety (HAD-A) and depression (HAD-D) symptoms. Scores range from 0-21 for each subscale, with higher scores indicating worse outcomes (greater anxiety or depression).
Fatigue Severity Scale (FFS)	Baseline assessment through to the last session of Week 3	a 9-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them. Sca;e 9-63 with higher score indicating greater fatigue.
Warwick-Edingburgh Mental Wellbeing Scale (WEMWBS)	Baseline assessment through to the last session of Week 3	developed to enable the measuring of mental wellbeing in the general population and the evaluation of projects, programmes and policies which aim to improve mental wellbeing. The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible. The scale has been widely used nationally and internationally for monitoring, evaluating projects and programmes and investigating the determinants of mental wellbeing. Scale 14-70 with higher score indicating better mental wellbeing.
Situational Vertigo Questionnaire (SVQ)	Baseline assessment through to the last session of Week 3	The SVQ is 20-item questionnaire designed to assess discomfort in situations of intense visual salience of visual-vestibular conflict. It was originally developed as a measure of space and motion discomfort. The questions are graded on a scale from 0 (not at all) to 4 (very much), with a higher score indicating greater vertigo severity.
User experience questionnaire (UEQ)	Post-intervention (end of Week 3)	he User Experience Questionnaire (UEQ; scale 1-7 on 26 dimensions of attractiveness, perspicuity, efficiency, dependability, stimulation and novelty with a score range of -3 (worst) to +3 (best) with a higher score indicating a more positive user experience.
The system Usability Scale (SUS)	Post-intervention (end of Week 3)	The System Usability Scale (SUS) scale 1-5 rated on 10 aspects, with a total possible score of 0-100, with a higher score indicated better usability.

Trial Locations

Locations (5)

University Medical Center Freiberg Neurocenter (UKLFR), Freiberg,; 🇩🇪 Freiburg, 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