Physio4FMD: protocol for a multicentre randomised controlled trial of specialist physiotherapy for functional motor disorder

Abstract

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Patients with functional motor disorder (FMD) experience persistent and disabling neurological symptoms such as weakness, tremor, dystonia and disordered gait. Physiotherapy is usually considered an important part of treatment; however, sufficiently-powered controlled studies are lacking. Here we present the protocol of a randomised controlled trial (RCT) that aims to evaluate the clinical and cost effectiveness of a specialist physiotherapy programme for FMD.</jats:p></jats:sec><jats:sec><jats:title>Methods/design</jats:title><jats:p>The trial is a pragmatic, multicentre, single blind parallel arm randomised controlled trial (RCT). 264 Adults with a clinically definite diagnosis of FMD will be recruited from neurology clinics and randomised to receive either the trial intervention (a specialist physiotherapy protocol) or treatment as usual control (referral to a community physiotherapy service suitable for people with neurological symptoms). Participants will be followed up at 6 and 12 months. The primary outcome is the Physical Function domain of the Short Form 36 questionnaire at 12 months. Secondary domains of measurement will include participant perception of change, mobility, health-related quality of life, health service utilisation, anxiety and depression. Health economic analysis will evaluate the cost impact of trial and control interventions from a health and social care perspective as well as societal perspective.</jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p>This trial will be the first adequately-powered RCT of physical-based rehabilitation for FMD.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p>International Standard Randomised Controlled Trials Number<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://doi.org/10.1186/ISRCTN56136713">ISRCTN56136713</jats:ext-link>. Registered 27 March 2018.</jats:p></jats:sec>