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Feasibility Study of Physiotherapy for Functional Motor Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02275000
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University College, London

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Conversion Disorder Other: 5 Day Physiotherapy Programme Other: Physiotherapy Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Feasibility Study of a Physiotherapy Programme for Patients With Functional Motor Symptoms (FMS).
Study Start Date : September 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
5 Day physiotherapy programme at the National Hospital for Neurology and Neurosurgery, Queen Square, London UK.
 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.
Active Comparator: Treatment as usual
Participants are referred to their local neuro-physiotherapy service and if appropriate placed on a waiting list for inpatient rehabilitation.
 Other: Physiotherapy
Treatment as usual physiotherapy. The participant will be referred to their closest NHS outpatient neuro-physiotherapy service.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Global Impression Scale of Change [ Time Frame: Approximately 4 weeks after randomisation (this will be immediately after treatment for the experimental arm) and 6 months ]
    Self rated 5 point Likert scale of change


Secondary Outcome Measures :
  1. Short Form 36 [ Time Frame: Baseline and 6 months ]
  2. Hospital Anxiety and Depression Scale [ Time Frame: Baseline, approximately 4 weeks after randomisation and 6 months ]
  3. EQ-5D-5L [ Time Frame: Baseline, approximately 4 weeks after randomisation and 6 months ]
  4. Brief Illness Perception Questionnaire [ Time Frame: Baseline, approximately 4 weeks after randomisation and 6 months ]
  5. Work and Social Adjustment Scale [ Time Frame: Baseline, approximately 4 weeks after randomisation and 6 months ]
  6. Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: Baseline, approximately 4 weeks after randomisation and 6 months ]
    self reported questionnaire of upper limb function

  7. Functional Mobility Scale [ Time Frame: Baseline, approximately 4 weeks after randomisation and 6 months ]
    Scale of assistance required when walking 5, 50 and 500 metres.

  8. Psychogenic Movement Disorders Rating Scale (PMDRS) [ Time Frame: Baseline, approximately 4 weeks after randomisation and 6 months ]
    Blind video analysis of movement

  9. Berg Balance Scale [ Time Frame: Baseline, approximately 4 weeks after randomisation and 6 months ]
  10. 10 metre Walk Test [ Time Frame: Baseline, approximately 4 weeks after randomisation and 6 months ]
    timed walk over 10 metres


Other Outcome Measures:
  1. Client Services Receipt Inventory (CSRI) [ Time Frame: Baseline and 6 month follow up ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275000


Locations
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United Kingdom
The National Hospital for Neurology and Neurosurgery
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College, London
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Glenn Nielsen UCL
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02275000    
Other Study ID Numbers: 14/LO/0573
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2015
Additional relevant MeSH terms:
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Conversion Disorder
Hysteria
Dissociative Disorders
Somatoform Disorders
 Mental Disorders
Histrionic Personality Disorder
Personality Disorders