Telerehabilitation Decision Support System: Pilot Testing Protocol

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 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 volunteers

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

Design model

Parallel

Treatments tested in this trial

  • TeleRehab DSS Pilot Test

    Device

    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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: High-TechnologyActive comparator 1 intervention
Group B: Low-TechnologyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 assessment (week 1) through to the last session of Week 3
2

Recruitment Rate (acceptability)

percentage of recruited participants that were eligible

Time frame
Baseline assessment (week 1) through to the last session of Week 3
3

Feasibility (protocol deviations/problems)

Incidence of protocol deviation and/or implementation problems reported during the intervention.

Time frame
Baseline assessment (week 1) through to the last session of week 3
4

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

Time frame
Baseline assessment (week 1) through to the last session of week 3

Secondary outcomes

1

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 assessment through to the last session of Week 3
2

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 assessment through to the last session of Week 3
3

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.

Time frame
Baseline assessment through to the last session of Week 3
4

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 assessment through to the last session of Week 3

Other outcomes

1

Falls

Occurence of falls, and reasoning if any falls took place, self-reported via a falls diary.

Time frame
collected weekly for the duration of the 3-week intervention
2

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

Time frame
post-intervention (week 3)
3

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.

Time frame
Baseline (week 1)
4

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.

Time frame
Baseline (week 1)

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

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