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.

Autor:	Liston M; Centre for Human and Applied Physiological Sciences, King's College London, London, UK matthew.liston@kcl.ac.uk., Genna G; The Ear Institute, University College London, London, UK., Maurer C; Department of Neurology and Neuroscience, Medical Center, University of Freiburg, Freiburg im Breisgau, Germany., Kikidis D; National and Kapodistrian University of Athens, Athens, Greece., Gatsios D; Unit of Medical Technology and Intelligent Information Systems, Department of Material Science and Engineering, University of Ioannina, Ioannina, Greece.; Department of Neurology, Medical School, University of Ioannina, Ioannina, Greece., Fotiadis D; Unit of Medical Technology and Intelligent Information Systems, Department of Material Science and Engineering, University of Ioannina, Ioannina, Greece., Bamiou DE; The Ear Institute, University College London, London, UK., Pavlou M; Centre for Human and Applied Physiological Sciences, King's College London, London, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2021 Feb 12; Vol. 11 (2), pp. e039254. Date of Electronic Publication: 2021 Feb 12.
DOI:	10.1136/bmjopen-2020-039254
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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