Telerehabilitation Decision Support System: Pilot Testing Protocol

NCT07079787 | Not Yet Recruiting

• 1 other identifier: UCLondon17413/002
• Study Type: interventional
• Target: 30
• Locations: 5 countries
• Sites: 5

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.

Conditions

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

Keywords

vestibular; rehabilitation; falls; balance; exercise; artificial intelligence; teleremedicine; physiotherapy

Outcome Measures

Primary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events (safety)

  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.

  Baseline assessment (week 1) through to the last session of Week 3

• Recruitment Rate (acceptability)

  percentage of recruited participants that were eligible

  Baseline assessment (week 1) through to the last session of Week 3

• Feasibility (protocol deviations/problems)

  Incidence of protocol deviation and/or implementation problems reported during the intervention.

  Baseline assessment (week 1) through to the last session of week 3

• Participants experience using the system (usability)

  Participants experience using the system gathered via qualitative feedback throughout the testing period and post-intervention via exit interviews

  Baseline assessment (week 1) through to the last session of week 3

• Adherence to Intervention

  percentage of prescribed sessions completed throughout the intervention

  Week 1 through to completion at week 3

• Drop-out rate (acceptability)

  Percentage of enrolled participants that were loss to follow-up or drop-outs

  Baseline (week 1) through to last session in week 3

Secondary Outcomes (13)

• Functional Gait Assessment (FGA)

  Baseline assessment through to the last session of Week 3

• Mini Balance Evaluation Systems Test (Mini-BESTest)

  Baseline assessment through to the last session of Week 3

• Montreal Cognitive Assessment (MoCA)

  Baseline assessment through to the last session of Week 3

• EuroQol five dimensional descriptive system (EQ-5D-5L)

  Baseline assessment through to the last session of Week 3

• Rapid Assessment of Physical Activity (RAPA)

  Baseline assessment through to the last session of Week 3

Other Outcomes (5)

• Falls

  collected weekly for the duration of the 3-week intervention

• System performance

  post-intervention (week 3)

• eHealth Literacy Assessment (eHEALS)

  Baseline (week 1)

Study Arms (2)

High-Technology

ACTIVE COMPARATOR

All TeleRehab DSS components: multisensory balance exercises, AR avatar, real-time feedback, AR gamified activities, sensor-monitored exercise performance, and additional cognitive training.

Device: TeleRehab DSS Pilot Test

Low-Technology

ACTIVE COMPARATOR

With depth camera, motion sensors and tablet for multisensory balance exercises, real time feedback, sensor monitored exercise performance and cognitive games. No exergames, no smartwatch, no mobile phone.

Device: TeleRehab DSS Pilot Test

Interventions

TeleRehab DSS Pilot Test DEVICE

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

High-Technology; Low-Technology

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Unable to provide a clinical letter confirming diagnosis.

Sponsors & Collaborators

• University College, London: lead
• National and Kapodistrian University of Athens: collaborator
• University Medical Center Freiburg: collaborator
• King Chulalongkorn Memorial Hospital: collaborator
• Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira: collaborator
• Institute of Communications and Computer Systems, Athens, Greece: collaborator
• University of Ioannina: collaborator
• Vilabs: collaborator
• BioIRC: collaborator
• Activage: collaborator
• Institue De Desenvolvimento De Novas Technologiassociacao: collaborator
• Quantitas SRL: collaborator
• Instituto para o Desenvolvimento e Inovação: collaborator
• BRIDG: collaborator

Study Sites (5)

University Medical Center Freiberg Neurocenter (UKLFR), Freiberg,

Freiburg im Breisgau, Germany

Location

National and Kapodistrian University of Athens

Athens, Greece

Location

Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira

Madeirã, Portugal

Location

King Chulalongeorn Memorial Hospital

Bangkok, Thailand

Location

University College London

London, W10 4DN, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction; Vestibular Diseases; Post-Acute COVID-19 Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Doris-Eva Bamiou, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doris-Eva Bamiou, PhD

CONTACT

+44 07813716768; d.bamiou@ucl.ac.uk

Brooke Nairn, MSc.

CONTACT

+44 07538640838; b.nairn@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to which study arm participants have been allocated to. Due to the nature of the study, the assessing and treating clinician cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this pilot testing study, participants will be blinded to their allocation gorup, but due to the nature of the study, assessors will not be. Participants will be randomised by condition (stroke, MCI, long covid-19, vestibular disorders) into either the high-technolog or low-technology solution and will carry out the intervention under the supervision of the assessing clinician.

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 23, 2025
• Study Start: July 25, 2025
• Primary Completion: August 18, 2025
• Study Completion: August 29, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 20 years after the research study has ended; July 2026 - July 2046
• Access Criteria: All study research team members at all clinical sites will comply with their local requirements with regards to the collection, storage, processing and disclosure of personal information and will uphold the Act's core principles. The creation of coded, depersonalised data where the participant's identifying information will be replaced by an unrelated sequence of characters will be in place. The digital data collected will be stored in digital format at each clinical sites secure safe haven data platform with encrypted and password protection. The data (hard copies) collected during the study will be stored in the study site file in a securely locked designated cabinet at each clinical site for the duration of the study.

Locations

DE (1); TH (1); GR (1); GB (1); PT (1)