Proof of Concept Study of EMBalance Decision Support System to Evaluate Balance Disorders
EMBalance
A Decision Support System Incorporating a Validated Patient-specific, Multi-scale Balance Hyper Model Towards Early Diagnostic Evaluation and Efficient Management Plan Formulation of Balance Disorders (EMBalance)
2 other identifiers
interventional
200
3 countries
3
Brief Summary
Balance is crucial for an individual's mobility and independence. Human balance is achieved and maintained by a complex set of sensorimotor systems that include sensory input from vision, proprioception and the vestibular system (motion, equilibrium, spatial orientation). This information is then integrated by the brain. This complexity leads to undiagnosed or mistreated patients with balance disorders for long period which can affect their daily activities. The EMBalance project is a research project funded by the European Union, involving 10 universities across Europe. Its aim is to create a Decision Support System (DSS) to support doctors in diagnosing and treating balance disorders. It will be available to primary and secondary care doctors of different specialties, levels of training and in different parts of the country. The DSS will:
- Be used by primary and secondary health care professionals
- Assist the doctor on the evaluation and management of dizzy patients
- Predict how the balance disorder may progress
- Reduce patient waiting time and the onward referrals
- Ensure patients receive prompt and efficient treatment plans The EMBalance randomised clinical trial (RCT) is a proof-of-concept, multicentre, single-blind, and parallel group study, conducted in Belgium, Germany, Greece and United Kingdom. At present, the question that this study aims to answer is whether the algorithms developed for the EMBalance Platform will yield meaningful information and how these algorithms and platform can be improved, performing an offline comparison of the classical diagnostic approach and the outcome of the EMBalance platform, without any consequence for the patient. Patients who present with balance related symptoms at primary care will be randomised to either intervention group (non-specialist doctor +DSS) or control group (non-specialist doctor -DSS). An overseeing expert will then confirm the diagnosis and management decisions made by the non-specialist doctors in order to determine whether the use of the DSS can help them in a more precise assessment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 26, 2016
February 1, 2016
6 months
February 29, 2016
October 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of diagnosis agreement
Agreement between the diagnosis established by the non-specialist doctors (using the DSS and not using DSS) and the "Gold Standard" as determined by an overseeing expert and according to current evidence based guidelines for the diagnosis/management of these disorders.
Through study completion, an average of 8 months
Percentage of management plan agreement
Agreement between the management plan established by the non-specialist doctors (using the DSS and not using DSS) and the "Gold Standard" as recommended by an overseeing expert and according to current evidence based guidelines for the diagnosis/management of these disorders.
Through study completion, an average of 8 months
Secondary Outcomes (10)
Number of initial diagnoses changed after investigations proposed
Through study completion, an average of 8 months
Number of referrals to secondary care needed
Through study completion, an average of 8 months
Name of investigations required for an accurate diagnosis
Through study completion, an average of 8 months
Overall improvement according to the patient (Better, stable, worse)
Change from baseline at 3 months (follow-up)
Overall improvement according to overseeing expert (Better, stable, worse)
Change from baseline at 3 months (follow-up)
- +5 more secondary outcomes
Study Arms (2)
Non-specialist doctor +DSS
EXPERIMENTALPatients allocated to +DSS group will receive the following intervention: * V1: appointment with a non-specialist doctor with the support of the DSS * V2: appointment with an overseeing expert * V3: DSS Customised Vestibular Physiotherapy * V4: follow-up visit with the overseeing expert
Non-specialist doctor -DSS
ACTIVE COMPARATORPatients allocated to -DSS group will receive the following intervention: * V1: appointment with a non-specialist doctor without the support of the DSS * V2: appointment with an overseeing expert * V3: Standard Physiotherapy Practice * V4: follow-up visit with the overseeing expert
Interventions
The EMBalance DSS is a program which summarises and structures clinical information. The structuring of medical information is based on algorithms that have been developed and are employed via the DSS platform. The non-specialist doctors who use the DSS will be asked to exercise their clinical judgement in order to come up with a diagnosis or management plan. The DSS use has the following characteristics: 1. Doctors can pace the process anyway they see fit (e.g. by switching from history taking to examination, stopping at any point, or going back to medical history) or by stopping the process entirely. 2. Although the EMBalance platform will propose 2-3 diagnosis (with probability estimation for each), doctors will be asked to either choose one of these or discard and choose their own.
After the initial appointment with the non-specialist doctor, all patients will be invited to attend a specialist neuro-otology clinic where they will be seen by an overseeing expert in order to undergo a "Gold Standard" diagnostic process, and determine the management plan appropriate to the diagnosis, which will be compared to the management plan previously advised by the non-specialist doctor. The overseeing expert will review investigations carried out, results assessed by the non-specialist doctor.
Customised vestibular exercise programme suggested by the DSS. Such exercises are based on the eye, head, and postural exercises that provoke a patient's symptoms. 1. Adaptation exercises incorporating gaze fixation and head movements and postural exercises are prescribed to promote recovery of the vestibule-ocular reflex (VOR) and vestibulo-spinal reflex function. Up to 5 exercises will be practised by the patient at home for approximately 1-2 minutes each, twice daily initially at a slow speed which gradually increases as symptoms improve. 2. Patients presenting vestibular migraine will perform a maximum of three exercises. These exercises will be chosen by the DSS from a range of established exercises and chosen according to the patient's symptoms when performing the exercise/type of movement.
Patient will be referred to a local physiotherapy service by his/her non-specialist doctor within 18 weeks from referral. Standard vestibular rehabilitation practice consists of a customised exercise programme, this is service dependent and tailored for patient's symptoms. The rehabilitation programme might include lifestyle advice and education, sometimes accompanied by a leaflet.
All patients will be reviewed after three months follow-up by the overseeing expert.
Eligibility Criteria
You may qualify if:
- Be capable of understanding the information provided
- Absence of dementia/uncontrolled psychiatric disorder
- Vertigo or chronic dizziness exacerbated by head movements (\<12 months)
- Sub-acute presentation of dizziness (up to 3 months) without presenting to emergency services
You may not qualify if:
- Subjects with learning disability or dementia
- Patients with uncontrolled psychiatric disorders
- Pregnant and breastfeeding women
- Patients' incapable or unwilling to give informed consent.
- Patients with acute vestibular disorders (present at Accident and Emergency).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- National and Kapodistrian University of Athenscollaborator
- Universiteit Antwerpencollaborator
- University Hospital Freiburgcollaborator
Study Sites (3)
Antwerp University Hospital
Edegem, 2650, Belgium
Freiburg University Medical Center
Freiburg im Breisgau, 79106, Germany
Hippocrateio Hospital
Athens, 115 27, Greece
Related Publications (10)
Colledge NR, Wilson JA, Macintyre CC, MacLennan WJ. The prevalence and characteristics of dizziness in an elderly community. Age Ageing. 1994 Mar;23(2):117-20. doi: 10.1093/ageing/23.2.117.
PMID: 8023718BACKGROUNDRoyal College of Physicians, Hearing and Balance Disorders, Report of a working party (2007) Available at: https://www.rcplondon.ac.uk/sites/default/files/documents/hearing-and-balance-disorders.pdf. [Accessed 29 September 2008]
BACKGROUNDPavlou M, Davies RA, Bronstein AM. The assessment of increased sensitivity to visual stimuli in patients with chronic dizziness. J Vestib Res. 2006;16(4-5):223-31.
PMID: 17538212BACKGROUNDNeuhauser HK, Radtke A, von Brevern M, Lezius F, Feldmann M, Lempert T. Burden of dizziness and vertigo in the community. Arch Intern Med. 2008 Oct 27;168(19):2118-24. doi: 10.1001/archinte.168.19.2118.
PMID: 18955641BACKGROUNDScuffham P, Chaplin S, Legood R. Incidence and costs of unintentional falls in older people in the United Kingdom. J Epidemiol Community Health. 2003 Sep;57(9):740-4. doi: 10.1136/jech.57.9.740.
PMID: 12933783BACKGROUNDKeen, P. & Morton, M. S. (1978). Decision Support Systems: An Organizational Perspective, Addison-Wesley
BACKGROUNDEom, S. & Kim, E. A survey of decision support system applications. Journal of the Operational Research Society. 2006, 57(15): 1264-1278
BACKGROUNDGarg AX, Adhikari NK, McDonald H, Rosas-Arellano MP, Devereaux PJ, Beyene J, Sam J, Haynes RB. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005 Mar 9;293(10):1223-38. doi: 10.1001/jama.293.10.1223.
PMID: 15755945BACKGROUNDBamiou DE, Kikidis D, Bibas T, Koohi N, Macdonald N, Maurer C, Wuyts FL, Ihtijarevic B, Celis L, Mucci V, Maes L, Van Rompaey V, Van de Heyning P, Nazareth I, Exarchos TP, Fotiadis D, Koutsouris D, Luxon LM. Diagnostic accuracy and usability of the EMBalance decision support system for vestibular disorders in primary care: proof of concept randomised controlled study results. J Neurol. 2022 May;269(5):2584-2598. doi: 10.1007/s00415-021-10829-7. Epub 2021 Oct 20.
PMID: 34669009DERIVEDRammazzo L, Kikidis D, Anwer A, Macdonald N, Kyrodimos E, Maurer C, Wuyts F, Luxon L, Bibas A, Bamiou DE. EMBalance - validation of a decision support system in the early diagnostic evaluation and management plan formulation of balance disorders in primary care: study protocol of a feasibility randomised controlled trial. Trials. 2016 Sep 5;17(1):435. doi: 10.1186/s13063-016-1568-x.
PMID: 27596486DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Doris-Eva Bamiou, MD MSc FRCP PhD
University College, London
- STUDY DIRECTOR
Linda M Luxon, CBE BSc FRCP FRCPE
Royal College of Physicians
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2016
First Posted
March 10, 2016
Study Start
March 1, 2016
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 26, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share