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

Overview

Journal BMJ Open

Specialty General Medicine

Date 2021 Feb 13

PMID 33579762

Citations 6

Authors

Matthew Liston

Gregory Genna

Christoph Maurer

Dimitris Kikidis

Dimitris Gatsios

Dimitris Fotiadis

Doris-Eva Bamiou

Marousa Pavlou

Affiliations

Soon will be listed here.

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.

Citing Articles

Feasibility and acceptability of the HOLObalance telerehabilitation system compared with standard care for older adults at risk of falls: the HOLOBalance assessor blinded pilot randomised controlled study.

Pavlou M, Flavell C, Gourtani F, Nikitas C, Kikidis D, Bibas A Age Ageing. 2024; 53(10).

PMID: 39373575 PMC: 11457341. DOI: 10.1093/ageing/afae214.

Mixed Reality Platforms in Telehealth Delivery: Scoping Review.

Worlikar H, Coleman S, Kelly J, OConnor S, Murray A, McVeigh T JMIR Biomed Eng. 2024; 8:e42709.

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Head mounted display effect on vestibular rehabilitation exercises performance.

Nikitas C, Kikidis D, Pardalis A, Tsoukatos M, Papadopoulou S, Bibas A J Frailty Sarcopenia Falls. 2023; 8(2):66-73.

PMID: 37275662 PMC: 10233325. DOI: 10.22540/JFSF-08-066.

The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review.

Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P Front Public Health. 2022; 10:953593.

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Automated Assessment of Balance Rehabilitation Exercises With a Data-Driven Scoring Model: Algorithm Development and Validation Study.

Tsakanikas V, Gatsios D, Pardalis A, Tsiouris K, Georga E, Bamiou D JMIR Rehabil Assist Technol. 2022; 9(3):e37229.

PMID: 36044258 PMC: 9475421. DOI: 10.2196/37229.

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