EMBalance. A feasibility/proof of concept study

  • Research type

    Research Study

  • Full 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

  • IRAS ID

    179741

  • Contact name

    Doris-Eva Bamiou

  • Contact email

    d.bamiou@ucl.ac.uk

  • Sponsor organisation

    University College London Hospitals NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    UCL Data Protection Registration, Z6364106/2016/01/56

  • Duration of Study in the UK

    0 years, 8 months, 30 days

  • Research summary

    Balance is crucial for an individual’s mobility and independence. Balance control relies on sensory inputs from vision (sight), joint and muscle proprioception (touch) and the vestibular system integration and modulation of sensory inputs within the brain; and motor output to the eye and body muscles. The EMBalance project aims to facilitate diagnosis and improve management of balance disorders as a result of a failure of the sensory inputs or of their integration within the central nervous system.

    EMBalance is a feasibility study, multicentre, single-blind, and parallel group study, conducted in Belgium, Germany, Greece and the UK. 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 (GP diagnosis assessment with DSS) or control group (GP diagnosis assessment without DSS). Finally, a Specialist Audiovestibular Consultant will confirm the diagnosis and management decisions made by the GPs in order to determine whether the use of the DSS can help non-specialist GPs in a more precise assessment.

  • REC name

    Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

  • REC reference

    16/YH/0051

  • Date of REC Opinion

    4 Feb 2016

  • REC opinion

    Favourable Opinion