DizzinessEMBalanceNCT02704819
Proof of Concept Study of EMBalance Decision Support System to Evaluate Balance Disorders
A study testing Decision Support System (DSS), Specialist Audiovestibular Consultation and DSS Customised Vestibular Physiotherapy in people with Dizziness and Vertigo, run by University College, London at 3 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- Decision Support System (DSS), Specialist Audiovestibular Consultation and DSS Customised Vestibular Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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.
Read more
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.
Read the 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)
- Being tested
- Decision Support System (DSS), Specialist Audiovestibular Consultation, DSS Customised Vestibular Physiotherapy, Standard Physiotherapy Practice, Follow-up
- Keywords
- Decision Support System, Dizziness, Vertigo, Balance
- Medical subject headings
- Dizziness, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Support System (DSS)Other
Also called Decision Making Software
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:
- 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.
- 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.
Specialist Audiovestibular ConsultationOther
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.
DSS Customised Vestibular PhysiotherapyOther
Also called Vestibular Rehabilitation
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.
- 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.
- 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.
Standard Physiotherapy PracticeOther
Also called Standard Rehabilitation 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.
Follow-upOther
All patients will be reviewed after three months follow-up by the overseeing expert.
| Study group | Role | What they receive |
|---|---|---|
| Non-specialist doctor +DSS | Experimental | 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 Receives: Other: Decision Support System (DSS); Other: Specialist Audiovestibular Consultation; Other: DSS Customised Vestibular Physiotherapy; Other: Follow-up |
| Non-specialist doctor -DSS | Active comparator | 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 Receives: Other: Specialist Audiovestibular Consultation; Other: Standard Physiotherapy Practice; Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 8 months
Secondary outcomes (10)
Number of initial diagnoses changed after investigations proposed
Measured: Through study completion, an average of 8 months
Number of referrals to secondary care needed
Measured: Through study completion, an average of 8 months
Name of investigations required for an accurate diagnosis
Measured: Through study completion, an average of 8 months
Overall improvement according to the patient (Better, stable, worse)
Measured: Change from baseline at 3 months (follow-up)
Overall improvement according to overseeing expert (Better, stable, worse)
Measured: Change from baseline at 3 months (follow-up)
Severity of symptoms (Visual Analogue Scale from 1-10 (VAS))
Measured: Change from baseline at 3 months (follow-up)
Difficulties regarding dizziness (Dizziness Handicap Inventory questionnaire (DHI))
Measured: Change from baseline at 3 months (follow-up)
Quality of life (EQ-5D-3L Questionnaire)
Measured: Change from baseline at 3 months (follow-up)
Number of patients not enrolled and/or withdrawn from the trial
Measured: Through study completion, an average of 8 months
Reason for exclusion to the trial
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Universiteit Antwerpen, University Hospital Freiburg
- Responsible party
- Sponsor
- Investigators
- Doris-Eva Bamiou, MD MSc FRCP PhD, Principal investigator, University College, LondonLinda M Luxon, CBE BSc FRCP FRCPE, Study director, Royal College of Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704819
- Sponsor's protocol ID
- 13/0336
- Other IDs
- 610454
- Acronym
- EMBalance
- Status last verified
- Feb 2016
- First submitted
- 29 Feb 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 8023718Royal 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]
Pavlou 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.
PubMed 17538212Neuhauser 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.
PubMed 18955641Scuffham 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.
PubMed 12933783Keen, P. & Morton, M. S. (1978). Decision Support Systems: An Organizational Perspective, Addison-Wesley
Eom, S. & Kim, E. A survey of decision support system applications. Journal of the Operational Research Society. 2006, 57(15): 1264-1278
Garg 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.
PubMed 15755945Bamiou 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.
PubMed 34669009Rammazzo 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.
PubMed 27596486
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02704819
- Acronym / sponsor ID
- EMBalance / 13/0336
- Keywords
- Decision Support System, Dizziness, Vertigo, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Universiteit Antwerpen, University Hospital Freiburg
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-specialist doctor +DSS | Experimental | Other: Decision Support System (DSS), Other: Specialist Audiovestibular Consultation, Other: DSS Customised Vestibular Physiotherapy, Other: Follow-upPatients 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 comparator | Other: Specialist Audiovestibular Consultation, Other: Standard Physiotherapy Practice, Other: Follow-upPatients 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Support System (DSS)Also: Decision Making SoftwareThe 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 | Non-specialist doctor +DSS |
| Specialist Audiovestibular ConsultationAfter 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 | Non-specialist doctor +DSS, Non-specialist doctor -DSS |
| DSS Customised Vestibular PhysiotherapyAlso: Vestibular RehabilitationCustomised 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 | Non-specialist doctor +DSS |
| Standard Physiotherapy PracticeAlso: Standard Rehabilitation PracticePatient 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 | Non-specialist doctor -DSS |
| Follow-upAll patients will be reviewed after three months follow-up by the overseeing expert. | Other | Non-specialist doctor +DSS, Non-specialist doctor -DSS |
Primary outcome
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.
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.
10 secondary outcomes
Number of initial diagnoses changed after investigations proposed
Time frame: 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
Name of investigations required for an accurate diagnosis
Time frame: 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)
Overall improvement according to overseeing expert (Better, stable, worse)
Time frame: 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)
Difficulties regarding dizziness (Dizziness Handicap Inventory questionnaire (DHI))
Time frame: 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)
Number of patients not enrolled and/or withdrawn from the trial
Time frame: Through study completion, an average of 8 months
Reason for exclusion to the trial
Time frame: Through study completion, an average of 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Background: PubMed 8023718Colledge 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.
- BackgroundRoyal 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]
- Background: PubMed 17538212Pavlou 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.
- Background: PubMed 18955641Neuhauser 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.
- Background: PubMed 12933783Scuffham 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.
- BackgroundKeen, 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
- Background: PubMed 15755945Garg 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.
- Derived from this study: PubMed 34669009Bamiou 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.
- Derived from this study: PubMed 27596486Rammazzo 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.
- EMBalance Twitter accountLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Dizziness
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Recruiting
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
Multiple Sclerosis
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris-Eva Bamiou, MD MSc FRCP PhD principal investigator
University College, London
Linda M Luxon, CBE BSc FRCP FRCPE study director
Royal College of Physicians
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support System (DSS), Specialist Audiovestibular Consultation and DSS Customised Vestibular Physiotherapy in people with Dizziness and Vertigo, run by University College, London at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of diagnosis agreement (time frame: Through study completion, an average of 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704819, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.