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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Full/High Tech Telerehabilitation decision support system
DeviceThe 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.
Basic/Low Tech Telerehabilitation decision support system
DeviceThe 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.
OTAGO Home exercise program
Procedure/Surgerybalance rehabilitation program
Vestibular rehabilitation program
Procedure/Surgeryvestibular rehabilitation and dizziness program
Treatment groups
460 Participants
are divided into 4 treatment groupsGroup A: Full/High-tech TeleRehab DSSExperimental treatment 1 intervention
Group B: Basic/Low-tech TeleRehab DSSExperimental treatment 1 intervention
Group C: OTAGO Home Exercise programmeActive comparator 1 intervention
Group D: Vestibular rehabilitation programmeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate (acceptability)
percentage of recruited participants that were eligible
Time frame
Baseline (week 0) through to post-intervention at week 102
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.
Time frame
Baseline (week 0) through to post-intervention at week 103
Feasibility (protocol deviations/problems)
Incidence of protocol deviation and/or implementation problems reported during the intervention.
Time frame
Baseline (Week 0) through to post-intervention at week 104
Participants experience using the system (usability)
Participants experience using the system (perceived benefits) via via weekly check in on frustration levels, technical troubleshooting and any other usability considerations, as well as during exit interviews for all TeleRehab DSS group completers.
Time frame
weekly and post-intervention at week 10Secondary outcomes
1
Mini Balance Evaluation Systems Test (Mini-BESTest)
a 14-item test that assesses dynamic balance, on a scale of 0 (indicating severe balance impairment) to 28 (representing normal balance with a total score of 28 points.
Time frame
Baseline (week 0) & post intervention (Week 10)2
Functional Gait Assessment (FGA)
test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes).
Time frame
Baseline (week 0) & post intervention (Week 10)3
Incremental cost-effectiveness ratio (ICER)
Cost-effectiveness, by dividing the difference in mean QALYs; The Incremental Cost-Effectiveness Ratio (ICER) is calculated as the difference in cost (ΔC) divided by the difference in effectiveness (ΔE) between two interventions. Lower ICER values indicate better cost-effectiveness, while higher values suggest greater cost per unit of effectiveness gained. An intervention is considered cost-effective if its ICER falls below a predefined willingness-to-pay (WTP) threshold
Time frame
1 year before study to 1 year after the end of the intervention4
EuroQol five dimensional descriptive system (EQ-5D-5L)
Measure of quality-adjusted life years (QALYs). EQ-5D-5L is a standardized, valid and reliable simple, generic measure of health status for clinical and economic appraisal. The respondent is asked to rate their health status on these five dimensions from 1 to 5 respectively as no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS (Visual Analogue Scale) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The respondent is asked to mark an X on the scale to indicate "how your health is TODAY" with a higher score indicating better health-related quality of life .
Time frame
Baseline (week 0) & post intervention (Week 10)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: