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

NACompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
DizzinessVertigo
Interventions
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

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

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

Follow-up

All patients will be reviewed after three months follow-up by the overseeing expert.

Trial Locations (3)

2650

Antwerp University Hospital, Edegem

79106

Freiburg University Medical Center, Freiburg im Breisgau

115 27

Hippocrateio Hospital, Athens

All Listed Sponsors
collaborator

National and Kapodistrian University of Athens

OTHER

collaborator

Universiteit Antwerpen

OTHER

collaborator

University Hospital Freiburg

OTHER

lead

University College, London

OTHER

NCT02704819 - Proof of Concept Study of EMBalance Decision Support System to Evaluate Balance Disorders | Biotech Hunter | Biotech Hunter