Abstract
BackgroundPatients 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.Methods/designThe 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.DiscussionThis trial will be the first adequately-powered RCT of physical-based rehabilitation for FMD.Trial registrationInternational Standard Randomised Controlled Trials Number ISRCTN56136713. Registered 27 March 2018.
Highlights
DiscussionThis trial will be the first adequately-powered randomised controlled trial (RCT) of physical-based rehabilitation for functional motor disorder (FMD)
Patients with functional motor disorder (FMD) experience persistent and disabling neurological symptoms such as weakness, tremor, dystonia and disordered gait
There are a number of small studies showing promise that specialist physiotherapy is effective for people with FMD, there is a lack of evidence from adequately-powered randomised controlled trials (RCTs)
Summary
This will be the first adequately powered, parallel group design RCT of physiotherapy or physical rehabilitation for FMD. We support the choice of our primary outcome because the SF36 Physical Function domain has been found to be a valid measure of physical and mobility related disability [21]. While it is a self-report measure, it asks respondents to report limitations on their ability to carry out particular activities rather than the level of distress associated with these. A positive result should have an international impact, providing an impetus for the development of FMD services beyond the UK This is a trial of neurology and physiotherapy treatment, the data gathered on the usefulness of the trial intervention may well have important implications for the clinical practice of occupational therapists, psychiatrists and psychologists working with people with functional neurological disorder.
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