A specialist physiotherapy programme for Functional Motor Disorder (FMD) is being tested against standard NHS care in a trial of 264 adults across eight hospitals in England and Scotland. FMD causes symptoms such as weakness, tremor, and walking difficulties that are genuine but not explained by structural brain damage. Current treatment is inconsistent—patients often receive a diagnosis and a referral to community physiotherapy, but no standardised, evidence-based therapy exists. This leaves many people with persistent disability and no clear path to recovery. If the trial shows the new protocol works, it would give the NHS a proven, deliverable treatment for a condition that currently has none. The intervention involves nine sessions over three weeks, with education, movement retraining, and a self-management plan. A positive result could change clinical guidelines, reduce long-term disability, and cut healthcare costs by replacing ad hoc care with a structured, cost-effective alternative. The trial also includes a health economic analysis to assess whether the therapy saves money for the health and social care system, and whether it helps people return to work.
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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
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