Title: A randomised controlled trial of specialist physiotherapy for Functional Motor Disorder (Physio4FMD)
Funder: Department of Health and Social Care

Abstract: Aim: To evaluate the clinical and cost-effectiveness of a specialist physiotherapy intervention for functional motor disorder (FMD). Design: Single blind, multicentre, parallel arm, randomised controlled trial (with internal pilot). Setting: 8 outpatient neurology services in England and Scotland and the corresponding physiotherapy departments. Target population: Adults with FMD. Inclusion criteria: Clinically definite diagnosis of FMD [1], aged 18 or over; completion of diagnostic investigations; acceptance of the treatment. Exclusion criteria: Severe psychiatric comorbidity; FMD is not the most disabling problem; requires assistance for toileting; unable to attend 9 sessions of physiotherapy over 3 weeks; unresolved compensation case; no fixed addressed or seeking rehousing through their council for disability access reasons; unable to understand English. Health technology: A novel physiotherapy treatment protocol involving education, movement retraining with redirection of motor attention, and long-term self-management plan. Treatment is delivered over 9 sessions within a 3 week period, plus a 3 month follow up session. Comparator: Treatment as usual, consisting of a standardised diagnostic explanation from the neurologist with at least one neurology follow up for all patients (both arms). Referral to the patient’s local community physiotherapy service (for controls). Measurement: Primary outcome: Physical Function domain of Short Form 36 (SF36-PF) [2] at 12 months. Secondary outcomes: remaining SF36 domains, Clinical Global Impression Scale [3], Functional Mobility Scale [4,5], Revised Illness Perception Questionnaire [6], and Hospital Anxiety and Depression Scale [7]. Health economic analysis will encompass health and social care costs with secondary analysis of the impact on employment. Measures: EQ-5D-5L [8] (used to calculate Quality Adjusted Life Years), Client Services Receipt Inventory [9], Work Productivity and Activity Impairment Questionnaire [10], and Hospital Episode Statistics (HES) for cost and resource use [11,12]. Sample size: Calculated to detect a 9 point difference in SF36-PF, using a repeated measures design (0.55 correlation), with 90% power, 5% significance, assuming SD of 22. Sample is inflated for 20% drop out and a therapist effect (ICC 0.05) [13]. The resulting sample size is 264 (132/group). Difference between current and planned care pathways: The control arm is the current care pathway. The intervention arm differs in the content of the physiotherapy sessions and may involve more sessions. Timetable: Duration is 43 months with 20 month recruitment period. An internal pilot will be conducted and assessed after 9 months using pre-specified stop/go criteria. The mean recruitment rate required to achieve full recruitment is 13.5/month. Proposed stages: 0-6 mth Set up and clinician training; 5-24 mth Recruitment; 5-13 mth Internal pilot; 36 mth completion of follow up; 38 mth database lock; 43 mth completion of data analysis and trial report. Expertise in team: The multidisciplinary team has expertise in physiotherapy, neurology, neuropsychiatry, psychology, statistics, health economics and running large multicentre trials in functional neurological symptoms, including a large NIHR-funded trial for dissociative seizures [3,14]. We will have ongoing service user involvement

Lay abstract: Background: Functional motor disorders (FMD) are disorders affecting movement, most commonly weakness, walking, balance and shaking. The problem relates to a disturbance in how messages from the brain reach different parts of the body rather than being a neurological disease or damage. The diagnosis is made by a neurologist. The disorder causes high levels of patient distress, and often unemployment and receipt of disability benefits. Long term outcomes are not good and most patients continue to have disabling symptoms. In the past, FMD was considered a psychological problem; however the most recent research shows that, while psychological factors are important for many patients, not everyone with FMD has a psychological problem. Recent research shows the abnormal movement in FMD is related to an excessive amount of the person’s attention being directed towards their body. When this attention is distracted away, their movement improves. Our research team has used this finding to develop a novel physiotherapy-based treatment, which has shown positive results in several small studies. Other studies have also found that specialist physiotherapy is effective, but there are no randomised controlled trials (RCTs), which are considered the best form of evidence. We plan to conduct such a trial. Aims: This study will test whether the specialist physiotherapy is better than standard care at reducing disability caused by FMD and whether the treatment could save the NHS money. Design and Methods: We will perform a large RCT comparing our specialist physiotherapy to standard care in 264 patients with FMD. Patients will be allocated to each treatment by chance using a computer programme. The specialist physiotherapy involves 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. In the UK, local services differ in how many sessions they offer patients; the average number is likely to be around 5 [15]. People in both groups will see their neurologist as normal, at least once during the study. People will be assessed at 6 and 12 months after enrolment, by completing 9 questionnaires sent by post which take about an hour to complete. We will also look at the number of hospital contacts recorded by the NHS for participants in each group to see if this changes. We will assess how the trial is progressing at month 14, after 9 months of recruitment, before continuing with the study. Patient and Public Involvement: Previous patients and a patient’s family member have reviewed this research plan. They were strongly supportive and have suggested ways to reduce the burden of the trial on participants and improve communication with GPs. We have support for this study from relevant patient organisations e.g. FNDHope.org. Dissemination: Results will be published in quality medical journals and presented at international conferences for health professionals. We will inform patients by publishing results on patient information websites. We will share the results and offer specialist training to physiotherapy departments around the UK. The study treatment guideline will be freely available after the trial. We will encourage and support participants to share their stories and information about the trial.

Research activity codes: 6.7 PHYSICAL
Health categories: MENTAL HEALTH;NEUROLOGICAL