NCT07079787|Not Yet Recruiting
Telerehabilitation Decision Support System: Pilot Testing Protocol
TeleRehab DSS
Telerehabilitation of Balance Clinical and Economic Decision Support System
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TeleRehab DSS
Telerehabilitation of Balance Clinical and Economic Decision Support System
Sponsor study identifier
interventional
30
5 countries
5
Study Start
July 25, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 18, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 29, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 29, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 30, 2025
Actual (reported)July 23, 2025
Actual (reported)July 25, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 18, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 29, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
All TeleRehab DSS components: multisensory balance exercises, AR avatar, real-time feedback, AR gamified activities, sensor-monitored exercise performance, and additional cognitive training.
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.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Medical Center Freiberg Neurocenter (UKLFR), Freiberg,
Freiburg im Breisgau, Germany
National and Kapodistrian University of Athens
Athens, Greece
Secretaria Regional de Saúde e Proteção Civil da Região Autónoma da Madeira
Madeirã, Portugal
Doris-Eva Bamiou, PhD
University College, London
First Submitted
June 30, 2025
First Posted
July 23, 2025
Study Start
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
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
Falls
collected weekly for the duration of the 3-week intervention
System performance
post-intervention (week 3)
eHealth Literacy Assessment (eHEALS)
Baseline (week 1)
Contact the study team to confirm eligibility.
King Chulalongeorn Memorial Hospital
Bangkok, Thailand
University College London
London, W10 4DN, United Kingdom
July 25, 2025
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 18, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 29, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 23, 2025
Record last verified: 2025-06
Anonymised data collected will be analysed for improving the system ahead of the full-scale RCT. No participant identifiable data will be included in the final study reports or in the process of dissemination of the study results. The participants will be guided to where they can access the final result publication(s). Anonymised data will be stored securely in an encrypted dashboard and data repository and will be available to other project members and other researchers in line with open science. The research data collected in the course of the study will be retained by UCL and other clinical partners in their capacity as a sponsor for 20 years after the research study has ended. The data will be then securely destroyed.
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Source: ClinicalTrials.gov.
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