RCT of Specialist Physiotherapy for Functional Motor Disorder
Research type
Research Study
Full title
A randomised controlled trial of Specialist Physiotherapy for Functional Motor Disorder (Physio4FMD)
IRAS ID
235388
Contact name
Glenn Nielsen
Contact email
Sponsor organisation
St George's, University of London
ISRCTN Number
ISRCTN56136713
Duration of Study in the UK
3 years, 6 months, 30 days
Research summary
Functional motor disorder (FMD), also known as conversion disorder, is a common disorder affecting movement. Patients typically present with weakness, tremor, spasms and difficulty walking. The problem is part of the spectrum of neurological symptoms that are not caused by a recognisable disease process and relates to a disturbance in motor control and sensory perception. People with FMD suffer disability and distress equivalent to people with neurodegenerative disease such as Parkinson’s disease. The prognosis of FMD is considered poor and current treatment options are limited. Physiotherapy is widely considered an important part of treatment, however there is limited evidence to supports its use.
We have developed a specialised physiotherapy treatment programme for people with FMD which showed promising results in a number of small studies. This trial will test whether the specialist physiotherapy programme is better than standard care at reducing disability caused by FMD and whether the treatment could save the NHS money.
We will perform a randomised controlled trial across several UK hospitals, comparing our specialist physiotherapy programme with standard care. Patients who are diagnosed with FMD by a neurologist will be invited to take part. Those who consent will be randomised to receive either our specialised physiotherapy programme or standard care. The specialist physiotherapy consists of 9 sessions completed over 3 weeks and a follow up session. The treatment includes education about FMD, learning ways to control movement, and developing a long-term plan to help symptoms improve. Standard care involves a referral to local community physiotherapy for strength, balance and walking exercises. Participants will be followed up at 6 and 12 months after enrolment, by completing 9 questionnaires sent by post or over the telephone. We will also compare the number of hospital contacts recorded by the NHS for participants in each group.
Lay Summary of Results
Why did we do this trial? Functional motor disorder (FMD) causes persistent disabling symptoms, forwhich there are few treatment options. Physiotherapy is widely considered to be an important part oftreatment but there is little evidence to prove that it is effective. We therefore wanted to test theeffectiveness of specialist physiotherapy for people with FMD. What did we do? We conducted arandomised controlled trial, comparing specialist physiotherapy to standard physiotherapy suitable forpeople with neurological symptoms. Between 19 October 2018 and 31 January 2022, we recruited 355adults with FMD to participate in the trial. Participants were randomly assigned to receive specialistphysiotherapy or standard physiotherapy for neurological symptoms. We used a range of questionnairesto compare the outcomes from the two treatments. We also explored the cost effectiveness (value formoney from the perspective of the National Health Service) of specialist physiotherapy. What did wefind? After 12-months, we found that both treatment groups improved in our main measurement,which assessed physical function (ability to walk, climb stairs, and complete moderate and vigorousactivities), and on average there was no difference between the groups. Participants were more likely toreport improvement in their motor symptoms if they received specialist physiotherapy (59% receivingspecialist physiotherapy reported improvement compared to 38% receiving standard physiotherapy).There were other benefits in specialist physiotherapy over standard physiotherapy, including slightlybettermentalhealthscoresanditwasmorecosteffectiveinthatthecostforimprovementwaslower
better mental health scores and it was more cost effective, in that the cost for improvement was lower.Both physiotherapy treatments appeared to be safe with no dangerous complications found. What doesthis mean? Physiotherapy is a safe and potentially useful treatment for a proportion of people withFMD. Physiotherapy specifically designed to help FMD appears to be more cost effective than standardneurological physiotherapy.
Has the registry been updated to include summary results?
Yes
If yes - please enter the URL to summary results
https://www.isrctn.com/ISRCTN56136713?q=physio4fmd&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10
Did you follow your dissemination plan submitted in the IRASapplication form (Q A51)?
Pending
If pending, date when dissemination is expected
2024-12-31
Have participants been informed of the results of the study?
Yes
If yes, describe and/or provide URLs to materials shared and howthey were shared
Participants were sent a lay summary of the trial results and the scientific report. Participants were sentthis information via their preferred method of contact, either email or post. A copy of the lay summarycan be accessed here https://www.physio4fmd.org/publications
Have you enabled sharing of study data with others?
No
If no, explain why sharing hasn't been enabled
Data sharing is planned, but is not yet enabled. We have ongoing post hoc analysis to complete. Oncecomplete we plan to enable sharing by the SGUL data repository. A sharing record has been created aspart of the planhttps://sgul.figshare.com/collections/Physio4FMD_A_randomised_controlled_trial_of_specialist_physiotherapy_for_function
Have you enabled sharing of tissue samples and associated datawith others?
No
If no, explain why
NAREC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/0486
Date of REC Opinion
3 Apr 2018
REC opinion
Favourable Opinion