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Investigating the feasibility and acceptability of the HOLOBalance system compared with standard care in older adults at risk for falls: study protocol for an assessor blinded pilot randomised controlled study

Liston, M; Genna, G; Maurer, C; Kikidis, D; Gatsios, D; Fotiadis, D; Bamiou, D-E; (2021) Investigating the feasibility and acceptability of the HOLOBalance system compared with standard care in older adults at risk for falls: study protocol for an assessor blinded pilot randomised controlled study. BMJ Open , 11 (2) , Article e039254. 10.1136/bmjopen-2020-039254. Green open access

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Abstract

INTRODUCTION: Approximately one in three of all older adults fall each year, with wide ranging physical, psychosocial and healthcare-related consequences. Exercise-based interventions are the cornerstone for falls prevention programmes, yet these are not consistently provided, do not routinely address all components of the balance system and are often not well attended. The HOLOBalance system provides an evidence-based balance training programme delivered to patients in their home environment using a novel technological approach including an augmented reality virtual physiotherapist, exergames and a remote monitoring system. The aims of this proof-of-concept study are to (1) determine the safety, acceptability and feasibility of providing HOLOBalance to community dwelling older adults at risk for falls and (2) provide data to support sample size estimates for a future trial. METHODS: A single (assessor) blinded pilot randomised controlled proof of concept study. 120 participants will be randomised to receive an 8-week home exercise programme consisting of either: (1) HOLOBalance or (2) The OTAGO Home Exercise Programme. Participants will be required to complete their exercise programme independently under the supervision of a physiotherapist. Participants will have weekly telephone contact with their physiotherapist, and will receive home visits at weeks 0, 3 and 6. Outcome measures of safety, acceptability and feasibility, clinical measures of balance function, disability, balance confidence and cognitive function will be assessed before and immediately after the 8 week intervention. Acceptability and feasibility will be explored using descriptive statistics, and trends for effectiveness will be explored using general linear model analysis of variance. ETHICS AND DISSEMINATION: This study has received institutional ethical approvals in Germany (reference: 265/19), Greece (reference: 9769/24-6-2019) and the UK (reference: 19/LO/1908). Findings from this study will be submitted for peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT04053829. PROTOCOL VERSION: V.2, 20 January 2020.

Type: Article
Title: Investigating the feasibility and acceptability of the HOLOBalance system compared with standard care in older adults at risk for falls: study protocol for an assessor blinded pilot randomised controlled study
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1136/bmjopen-2020-039254
Publisher version: https://doi.org/10.1136/bmjopen-2020-039254
Language: English
Additional information: This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
Keywords: geriatric medicine, rehabilitation medicine, telemedicine
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > The Ear Institute
URI: https://discovery.ucl.ac.uk/id/eprint/10122382
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