About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Full/High Tech Telerehabilitation decision support system
- Basic/Low Tech Telerehabilitation decision support system
- OTAGO Home exercise program
- Vestibular rehabilitation program
Treatment groups
Sponsors and collaborators
University College, London
Lead sponsor
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