Proof of Concept Study of EMBalance Decision Support System to Evaluate Balance Disorders (EMBalance)

October 25, 2016 updated by: University College, London

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Balance is crucial for an individual's mobility and independence. Dizziness and imbalance symptoms are one of the most common reasons for visits to a doctor and affect up to 30-40% of the population by 60 years of age. The healthcare service provision to address vestibular pathology remains inadequate and is regarded as low priority. The complexity of balance control mechanisms, the lack of medical expertise, and the absence of specialised equipment can be contributory factors to the mismanagement of patients suffering balance disorders. However, the mean number for patient visits to their Health Care providers required to establish a correct diagnosis and start appropriate treatment, both in the US and the UK, is 4.5. The overall socio-economic impact of balance disorders on the affected individual, patient's families as well as the burden on society and the health services is considerable.

Advances in computer science and artificial intelligence have allowed the development of computer systems that support clinical diagnosis or therapeutic and treatment decisions based on individualised patient data. However, a review of existing Decision Support Systems used in Medicine demonstrated there are not many successful integrated software systems or standalone tools that address the early diagnosis and effective management of balance disorders.

All this said, the EMBalance DSS has been developed as a supplementary and supportive tool for non-expert physicians faced with the challenge of addressing vestibular disorders.

The current study will assess the effectiveness of the EMBalance Decision Support System (DSS) for diagnosis and management of balance disorders in a feasibility/proof of concept study. Patients who present with balance related symptoms (specifically vertigo or dizziness exacerbated by head movements) in primary care, will be seen by a non-specialist doctor either with or without the support of the DSS, on a ratio 1:1.

Non-specialist doctors in each participating country are defined as follow:

  • UK: General Practitioners
  • Germany: Neurology residents
  • Belgium & Greece: ENT residents

Overseeing experts in each participating country are defined as follow:

  • UK: Consultant in audiovestibular medicine (AVM)
  • Germany: Neurologist
  • Belgium & Greece: ENT specialist with >10 years expertise in AVM/Neuro-otology

It is anticipated 100 participants will be recruited to each of the two treatment groups, giving a total of 200 participants across Europe. Each participating site in Greece, Belgium, Germany and United Kingdom will recruit 50 patients. Allocation will be performed based on randomisation tables that are produced in advance for each centre.

Statistical data analysis will be performed by the National and Kapodistrian University of Athens. The statistical analysis has been developed by the National and Kapodistrian University of Athens and reviewed by the Institute of Communication and Computer Science (Greece).

Quality and ethical assurance are supervised by the Trial Steering Committee (TSC) and Trial Management Group (TMG)

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Antwerp University Hospital
  • Germany
      • Freiburg, Germany, 79106
        • Freiburg University Medical Center
  • Greece
      • Athens, Greece, 115 27
        • Hippocrateio Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-specialist doctor +DSS

Patients 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
Other: Decision Support System (DSS)

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.
Other Names:
  • Decision Making Software
Other: Specialist Audiovestibular Consultation
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.
Other: DSS Customised Vestibular Physiotherapy

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.
Other Names:
  • Vestibular Rehabilitation
Other: Follow-up
All patients will be reviewed after three months follow-up by the overseeing expert.
Active Comparator: Non-specialist doctor -DSS

Patients 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
Other: Specialist Audiovestibular Consultation
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.
Other: Follow-up
All patients will be reviewed after three months follow-up by the overseeing expert.
Other: Standard Physiotherapy Practice
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.
Other Names:
  • Standard Rehabilitation Practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of diagnosis agreement
Time Frame: Through study completion, an average of 8 months
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
Time Frame: Through study completion, an average of 8 months
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 Outcome Measures

Outcome Measure
Time Frame
Number of initial diagnoses changed after investigations proposed
Time Frame: Through study completion, an average of 8 months
Through study completion, an average of 8 months
Number of referrals to secondary care needed
Time Frame: Through study completion, an average of 8 months
Through study completion, an average of 8 months
Name of investigations required for an accurate diagnosis
Time Frame: Through study completion, an average of 8 months
Through study completion, an average of 8 months
Overall improvement according to the patient (Better, stable, worse)
Time Frame: Change from baseline at 3 months (follow-up)
Change from baseline at 3 months (follow-up)
Overall improvement according to overseeing expert (Better, stable, worse)
Time Frame: Change from baseline at 3 months (follow-up)
Change from baseline at 3 months (follow-up)
Severity of symptoms (Visual Analogue Scale from 1-10 (VAS))
Time Frame: Change from baseline at 3 months (follow-up)
Change from baseline at 3 months (follow-up)
Difficulties regarding dizziness (Dizziness Handicap Inventory questionnaire (DHI))
Time Frame: Change from baseline at 3 months (follow-up)
Change from baseline at 3 months (follow-up)
Quality of life (EQ-5D-3L Questionnaire)
Time Frame: Change from baseline at 3 months (follow-up)
Change from baseline at 3 months (follow-up)
Number of patients not enrolled and/or withdrawn from the trial
Time Frame: Through study completion, an average of 8 months
Through study completion, an average of 8 months
Reason for exclusion to the trial
Time Frame: Through study completion, an average of 8 months
Through study completion, an average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

National and Kapodistrian University of Athens
University Hospital Freiburg
Universiteit Antwerpen

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/0336
  • 610454 (Other Grant/Funding Number: EU Seventh Framework Programme)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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