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 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.
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
Parallel
Treatments tested in this trial
TeleRehab DSS Pilot Test
DeviceParticipants 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Recruitment Rate (acceptability)
percentage of recruited participants that were eligible
Feasibility (protocol deviations/problems)
Incidence of protocol deviation and/or implementation problems reported during the intervention.
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
Secondary outcomes
Functional Gait Assessment (FGA)
test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes).
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).
Montreal Cognitive Assessment (MoCA)
includes sections on visuospatial/executive function, naming, attention, language, abstraction, memory and orientation to time and place (6 questions) with a scor range from 0-30, with a higher score indicating better cognitive function.
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
Other outcomes
Falls
Occurence of falls, and reasoning if any falls took place, self-reported via a falls diary.
System performance
We will also compare the TeleRehaB DSS predicted versus observed patient outcomes on the EQ-5D-5L, and secondary outcome measures, to assess the system performance
eHealth Literacy Assessment (eHEALS)
a 10-item likert scale questionnaire that evaluate's patients' skills in finding, evaluating and applying electronic health information. Responses range from 1 (strongly disagree, to 65 (strong agree), with total scores indicating levels of eHealth literacy. This will be used to help validate the AI-model in terms of participant allocation into the high-tech versus low-tech solution.
The Senior technology acceptance & adoption model (STAM)
is a 38-item questionnaire, with items rated on a 1-10 Likert scale to measure factors influencing technology acceptance among older adults, with a higher scores indicating greater perceived digital literacy.
Sponsors and contacts
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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
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