Evidence map›Paper›PMID 33579762›Full record

ArticleBMJ open2021

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.

Matthew Liston, Gregory Genna, Christoph Maurer, Dimitris Kikidis, Dimitris Gatsios, Dimitris Fotiadis, Doris-Eva Bamiou, Marousa Pavlou

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04053829 (A Phase 2 Study to Investigate the Feasibility and Acceptability of the HOLOBalance System Compared to Standard Care in Older Adults at Risk for Falls), which is not on this map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
4.5field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04053829 naunknown statusnot on this map

A Phase 2 Study to Investigate the Feasibility and Acceptability of the HOLOBalance System Compared to Standard Care in Older Adults at Risk for Falls: a Multi-site Study

TypeinterventionalSponsorKing's College LondonRan2020 to 2021Enrolled120ConditionsAccidental Falls, Aging, Vestibular DisorderArmsHOLOBalance, OTAGO Home Exercise Programme
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 3 countries.

Matthew ListonCentre for Human and Applied Physiological Sciences, King's College London, London, UK matthew.liston@kcl.ac.uk.ORCID 0000-0002-9694-6268
Gregory GennaThe Ear Institute, University College London, London, UK.ORCID 0000-0001-6564-3101
Christoph MaurerDepartment of Neurology and Neuroscience, Medical Center, University of Freiburg, Freiburg im Breisgau, Germany.
Dimitris KikidisNational and Kapodistrian University of Athens, Athens, Greece.
Dimitris GatsiosUnit of Medical Technology and Intelligent Information Systems, Department of Material Science and Engineering, University of Ioannina, Ioannina, Greece.
Dimitris FotiadisUnit of Medical Technology and Intelligent Information Systems, Department of Material Science and Engineering, University of Ioannina, Ioannina, Greece.
Doris-Eva BamiouThe Ear Institute, University College London, London, UK.
Marousa PavlouCentre for Human and Applied Physiological Sciences, King's College London, London, UK.
King's College London · GBUniversity College London · GBUniversity of Ioannina · GRNational and Kapodistrian University of Athens · GRUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionApproximately 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.

methodsA 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.

Indexed as

Accidental FallsExercise TherapyAgedFeasibility StudiesGermanyGreeceHumansPilot ProjectsRandomized Controlled Trials as Topicgeriatric medicinerehabilitation medicinetelemedicine

Identifiers

PMID33579762
PMCPMC7883859
OpenAlexW3128959408

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.