Feasibility Study of Physiotherapy for Functional Motor Symptoms

Study Overview
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Brief Summary
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The aim of this study is to develop and assess the feasibility of a physiotherapy intervention for people with functional motor symptoms (also known as psychogenic neurological symptoms and conversion disorder). Participants will be randomised to receive the intervention or a treatment as usual control.

Detailed Description
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Participants will be recruited from outpatient neurology clinics at Queen Square. Those who consent to take part will complete baseline outcome measures (Time 1) before being randomised to either a Treatment as Usual control group or the Intervention group. Treatment as Usual group - Participants will be directed to online patient information resources (www.neurosymptoms.org) Participants will be placed on the waiting list to be assessed for the inpatient treatment programme for functional symptoms at The National Hospital for Neurology and Neurosurgery. The waitlist is currently greater than 12 months. A referral is made to local community therapy services (which may include physiotherapy, occupational therapy and psychological therapy). If the participant has had contact from their community therapy services in the previous 12 months, a letter summarising the participant's diagnosis and physiotherapy needs will be sent. Participants will be asked to return at 4 weeks to complete outcome measures for a second time (Time 2) A referral to community therapy for such patients is usual practice in the UK, although the form in which the community therapy is provided tends to be inconsistent across the UK. In most cases it will entail between 1 and 8 outpatient or domiciliary physiotherapy appointments. Some communities will have access to Occupational Therapy, which may entail supported practice and advice to increase independence with functional tasks and the provision of equipment. The provision of community therapy to participants will be monitored through the CSRI. Intervention Group - For participants allocated to the intervention group, a 5 day admission on the Day Hospital at the National Hospital for Neurology and Neurosurgery is arranged. The physiotherapy intervention will take place in the physiotherapy department. Participants will be admitted individually (and not in groups). Outside of physiotherapy times participants are encouraged to rest in the day hospital and complete a workbook. A single independent physiotherapist will be trained to deliver the intervention. The participant (+/- family member) will attend an initial meeting with the consultant neurologist and the treating physiotherapist. The neurologist will perform a brief neurological assessment and confirm the diagnosis. The diagnosis will be explained again to the patient, using the word functional to describe the diagnosis. Physical signs of FMS will be demonstrated to the patient. This includes distractibility, Hoover's sign and entrainment. The treatment programme will be explained to the patient, linking resolution of symptoms with treatment rationale. The participant will attend 8-9 physiotherapy sessions over the 5 days. The intervention is a combination of education on functional motor symptoms, movement retraining and development of a self management plan. After the final physiotherapy session, the participant will complete the outcome measures (Time 2) and a feedback form. Both groups will be followed up at 6 months after recruitment to the study (Time 3). An independent assessor will administer the outcome measures.

Official Title
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Randomised Feasibility Study of a Physiotherapy Programme for Patients With Functional Motor Symptoms (FMS).

Conditions
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Conversion Disorder

Intervention / Treatment
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* Other: 5 Day Physiotherapy Programme
* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinically established diagnosis of functional motor symptoms according to the Fahn-Williams criteria. Diagnostic investigations have come to an end. The patient accepts the diagnosis of functional motor symptoms. Symptom duration of at least six months. Symptoms must be sufficient to cause significant distress (subjectively described by the patient) or impairment in social, occupational or other important areas of functioning. Exclusion Criteria: Unable to understand English. Pain, fatigue or dissociative seizures is the predominant symptom. Prominent untreated axis 1 disorders (e.g. anxiety or depression). Level of disability prevents participation in a 5 day outpatient programme (Barthel Index score less than 25/100) Patient unable to attend 5 consecutive days.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>5 Day physiotherapy programme at the National Hospital for Neurology and Neurosurgery, Queen Square, London UK. | Other: 5 Day Physiotherapy Programme<br>* The experimental group will complete a 5 day physiotherapy programme consisting of education, movement retraining and a self management plan.<br>|
| Active Comparator: Treatment as usual<br>Participants are referred to their local neuro-physiotherapy service and if appropriate placed on a waiting list for inpatient rehabilitation. | Other: Physiotherapy<br>* Treatment as usual physiotherapy. The participant will be referred to their closest NHS outpatient neuro-physiotherapy service.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scale of Change | Self rated 5 point Likert scale of change | Approximately 4 weeks after randomisation (this will be immediately after treatment for the experimental arm) and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 |  | Baseline and 6 months | 
| Hospital Anxiety and Depression Scale |  | Baseline, approximately 4 weeks after randomisation and 6 months | 
| EQ-5D-5L |  | Baseline, approximately 4 weeks after randomisation and 6 months | 
| Brief Illness Perception Questionnaire |  | Baseline, approximately 4 weeks after randomisation and 6 months | 
| Work and Social Adjustment Scale |  | Baseline, approximately 4 weeks after randomisation and 6 months | 
| Disabilities of the Arm, Shoulder and Hand (DASH) | self reported questionnaire of upper limb function | Baseline, approximately 4 weeks after randomisation and 6 months | 
| Functional Mobility Scale | Scale of assistance required when walking 5, 50 and 500 metres. | Baseline, approximately 4 weeks after randomisation and 6 months | 
| Psychogenic Movement Disorders Rating Scale (PMDRS) | Blind video analysis of movement | Baseline, approximately 4 weeks after randomisation and 6 months | 
| Berg Balance Scale |  | Baseline, approximately 4 weeks after randomisation and 6 months | 
| 10 metre Walk Test | timed walk over 10 metres | Baseline, approximately 4 weeks after randomisation and 6 months |