Feasibility Study of Physiotherapy for Functional Motor Symptoms

Conversion Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275000
• Other study ID #: 14/LO/0573
• Status: Completed
• Phase: N/A
• First received: October 20, 2014
• Last updated: May 13, 2016
• Start date: September 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2015
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 -

1. Participants will be directed to online patient information resources (www.neurosymptoms.org)

2. 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.

3. 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.

4. 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.

1. The diagnosis will be explained again to the patient, using the word "functional" to describe the diagnosis.

2. Physical signs of FMS will be demonstrated to the patient. This includes distractibility, Hoover's sign and entrainment.

3. The treatment programme will be explained to the patient, linking resolution of symptoms with treatment rationale.

4. 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.

5. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conversion Disorder
• Dissociative Disorders

Intervention

Other:
• 5 Day Physiotherapy Programme
The experimental group will complete a 5 day physiotherapy programme consisting of education, movement retraining and a self management plan.
• Physiotherapy
Treatment as usual physiotherapy. The participant will be referred to their closest NHS outpatient neuro-physiotherapy service.

Locations

Country	Name	City	State
United Kingdom	The National Hospital for Neurology and Neurosurgery	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client Services Receipt Inventory (CSRI)	This questionnaire collects retrospective information about the use of health and social care services, income, employment and benefits. It can be used to calculate service costs and total costs of care.	Baseline and 6 month follow up	No
Primary	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	No
Secondary	Short Form 36		Baseline and 6 months	No
Secondary	Hospital Anxiety and Depression Scale		Baseline, approximately 4 weeks after randomisation and 6 months	No
Secondary	EQ-5D-5L		Baseline, approximately 4 weeks after randomisation and 6 months	No
Secondary	Brief Illness Perception Questionnaire		Baseline, approximately 4 weeks after randomisation and 6 months	No
Secondary	Work and Social Adjustment Scale		Baseline, approximately 4 weeks after randomisation and 6 months	No
Secondary	Disabilities of the Arm, Shoulder and Hand (DASH)	self reported questionnaire of upper limb function	Baseline, approximately 4 weeks after randomisation and 6 months	No
Secondary	Functional Mobility Scale	Scale of assistance required when walking 5, 50 and 500 metres.	Baseline, approximately 4 weeks after randomisation and 6 months	No
Secondary	Psychogenic Movement Disorders Rating Scale (PMDRS)	Blind video analysis of movement	Baseline, approximately 4 weeks after randomisation and 6 months	No
Secondary	Berg Balance Scale		Baseline, approximately 4 weeks after randomisation and 6 months	No
Secondary	10 metre Walk Test	timed walk over 10 metres	Baseline, approximately 4 weeks after randomisation and 6 months	No