Telerehabilitation of Balance Clinical and Economic Decision Support System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity College, London

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

460 Participants
are divided into 4 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