Telerehabilitation of Balance Clinical and Economic Decision Support System

NCT06534164 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2025-07-10

No results posted yet for this 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 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.

Conditions

Interventions

DEVICE

Full/High Tech Telerehabilitation decision support system

The TeleRehaB DSS intervention includes balance rehabilitation programme delivered via an augmented reality hologram of a virtual physiotherapist. The system delivers exercises demonstrated via a hologram of the physiotherapist and corrected in real time by the hologram prompts based on performance monitoring via sensors. 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. Exercise progressions will be suggested by the AI-supported TeleRehaB DSS and approved by the clinicians, which will be loaded into the participant's programme.

DEVICE

Basic/Low Tech Telerehabilitation decision support system

The basic system does not inlcude exergames, a smartwatch, or a mobile phone for activity tracking. It includes different multisensory balance and gait exercise, cognitive training and real-time feedback from motion sensors. Exercise progressions will be suggested by the AI-supported TeleRehaB DSS and approved by the clinicians, which will be loaded into the participant's programme.

PROCEDURE

OTAGO Home exercise program

balance rehabilitation program

PROCEDURE

Vestibular rehabilitation program

vestibular rehabilitation and dizziness program

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    collaborator OTHER
  • University Medical Center Freiburg

    collaborator OTHER
  • King Chulalongkorn Memorial Hospital

    collaborator OTHER
  • Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira

    collaborator UNKNOWN
  • Institute of Communications and Computer Systems, Athens, Greece

    collaborator OTHER
  • University of Ioannina

    collaborator OTHER
  • Vilabs

    collaborator UNKNOWN
  • BioIRC

    collaborator UNKNOWN
  • Activage

    collaborator UNKNOWN
  • Institue De Desenvolvimento De Novas Technologiassociacao

    collaborator UNKNOWN
  • Quantitas SRL

    collaborator UNKNOWN
  • Instituto para o Desenvolvimento e Inovação

    collaborator UNKNOWN
  • BRIDG

    collaborator UNKNOWN
  • University College, London

    lead OTHER

Principal Investigators

  • Doris-Eva Bamiou, PhD · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-06-30
Completion
2026-08-31

Countries

  • Germany
  • Greece
  • Portugal
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06534164 on ClinicalTrials.gov