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

Glenn Nielsen; Jon Stone; Marta Buszewicz; Alan Carson; Laura Hilary Goldstein; Kate Holt; Rachael Hunter; Jonathan Marsden; Louise Marston; Hayley Noble; Markus Reuber; Mark Edwards

doi:10.1186/s12883-019-1461-9

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

Glenn Nielsen, Jon Stone, Marta Buszewicz, Alan Carson, Laura Hilary Goldstein, Kate Holt, Rachael Hunter, Jonathan Marsden, Louise Marston, Hayley Noble, Markus Reuber, Mark Edwards

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Abstract

Background: 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. Methods/design: 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. Discussion: This trial will be the first adequately-powered RCT of physical-based rehabilitation for FMD.

Original language	English
Article number	242
Journal	BMC Neurology
Volume	19
Issue number	1
DOIs	https://doi.org/10.1186/s12883-019-1461-9
Publication status	Published - 21 Oct 2019

Keywords

Clinical trial
Conversion disorder
Functional
Functional motor disorder
Physical therapy
Physiotherapy
Psychogenic
Randomised controlled trial

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abstract = "Background: 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. Methods/design: 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. Discussion: This trial will be the first adequately-powered RCT of physical-based rehabilitation for FMD.",

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AU - Holt, Kate

AU - Hunter, Rachael

AU - Marsden, Jonathan

AU - Marston, Louise

AU - Noble, Hayley

AU - Reuber, Markus

AU - Edwards, Mark

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AB - Background: 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. Methods/design: 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. Discussion: This trial will be the first adequately-powered RCT of physical-based rehabilitation for FMD.

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

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