A randomised controlled trial of Specialist Physiotherapy for Functional Motor Disorder (Physio4FMD)

Study ID: 36950
Short Title: RCT of Specialist Physiotherapy for Functional Motor Disorder
Organisation: Dorset County Hospital NHS Foundation Trust
Location: Dorset County Hospital
Condition: Other
Main Specialty: Neurological disorders
Expected End Date: 30/04/2020
Postcode: DT1 2JY
Contact Name: R&D department
Contact Email: simon.sharpe@dchft.nhs.uk
Active: Yes

Inclusion Criteria

1. New or returning patients presenting to participating outpatient neurology clinics. 2. The patient has a “clinically definite” diagnosis of FMD according to the Gupta and Lang diagnostic classification criteria [6]. 3. Age 18 or over. 4. Diagnostic investigations have come to an end. 5. The patient is accepting of the intervention. 6. Motor symptoms must be sufficient to cause significant distress or impairment in social, occupational or other important areas of functioning (subjectively described by the patient), independent of other comorbidities.

Exclusion Criteria

1. The recruiting neurologist deems the patient to have severe psychiatric co-morbidity, including factitious disorder, self-harm, anxiety and depression, which would interfere with the patient’s ability to participate in physiotherapy.** 2. The patient has an organic diagnosis which explains the majority of their symptoms or disability. 3. Pain, fatigue or dissociative seizures are the most disabling symptom. 4. Disability to the extent that the patient requires assistance for toileting. 5. The patient is unable to attend 9 sessions of physiotherapy over a 3 week period, within 6 weeks of initial neurology consultation. 6. Ongoing unresolved compensation claim or litigation. 7. The patient has no fixed address or is seeking rehousing through their council for disability access reasons. 8. Unable to understand English sufficiently to complete questionnaires. 9. The patient has a diagnosed learning disability that prevents them from answering questionnaires independently. 10. The patient lacks capacity to give consent. ** The decision to exclude a patient due to psychiatric comorbidity is a clinical decision made by the neurologist, rather than a decision based on a screening tool or questionnaire. We believe that no single screening tool or questionnaire would serve this purpose (due to the range of potential psychiatric problems. Additionally, there is insufficient data on which to base cut-off scores to exclude patients on any particular questionnaire. The recruiting neurologists involved in the trial are consultants in neurology, selected for their experience in managing patients with FMD and patients with psychiatric comorbidity.

Study 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.

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