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Feasibility Study of Physiotherapy for Functional Motor Symptoms

Primary Purpose

Conversion Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
5 Day Physiotherapy Programme
Physiotherapy
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conversion Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The National Hospital for Neurology and Neurosurgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Treatment as usual

Arm Description

5 Day physiotherapy programme at the National Hospital for Neurology and Neurosurgery, Queen Square, London UK.

Participants are referred to their local neuro-physiotherapy service and if appropriate placed on a waiting list for inpatient rehabilitation.

Outcomes

Primary Outcome Measures

Clinical Global Impression Scale of Change
Self rated 5 point Likert scale of change

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2014
Last Updated
May 13, 2016
Sponsor
University College, London
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02275000
Brief Title
Feasibility Study of Physiotherapy for Functional Motor Symptoms
Official Title
Randomised Feasibility Study of a Physiotherapy Programme for Patients With Functional Motor Symptoms (FMS).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 - 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conversion Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
5 Day physiotherapy programme at the National Hospital for Neurology and Neurosurgery, Queen Square, London UK.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Participants are referred to their local neuro-physiotherapy service and if appropriate placed on a waiting list for inpatient rehabilitation.
Intervention Type
Other
Intervention Name(s)
5 Day Physiotherapy Programme
Intervention Description
The experimental group will complete a 5 day physiotherapy programme consisting of education, movement retraining and a self management plan.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Treatment as usual physiotherapy. The participant will be referred to their closest NHS outpatient neuro-physiotherapy service.
Primary Outcome Measure Information:
Title
Clinical Global Impression Scale of Change
Description
Self rated 5 point Likert scale of change
Time Frame
Approximately 4 weeks after randomisation (this will be immediately after treatment for the experimental arm) and 6 months
Secondary Outcome Measure Information:
Title
Short Form 36
Time Frame
Baseline and 6 months
Title
Hospital Anxiety and Depression Scale
Time Frame
Baseline, approximately 4 weeks after randomisation and 6 months
Title
EQ-5D-5L
Time Frame
Baseline, approximately 4 weeks after randomisation and 6 months
Title
Brief Illness Perception Questionnaire
Time Frame
Baseline, approximately 4 weeks after randomisation and 6 months
Title
Work and Social Adjustment Scale
Time Frame
Baseline, approximately 4 weeks after randomisation and 6 months
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
self reported questionnaire of upper limb function
Time Frame
Baseline, approximately 4 weeks after randomisation and 6 months
Title
Functional Mobility Scale
Description
Scale of assistance required when walking 5, 50 and 500 metres.
Time Frame
Baseline, approximately 4 weeks after randomisation and 6 months
Title
Psychogenic Movement Disorders Rating Scale (PMDRS)
Description
Blind video analysis of movement
Time Frame
Baseline, approximately 4 weeks after randomisation and 6 months
Title
Berg Balance Scale
Time Frame
Baseline, approximately 4 weeks after randomisation and 6 months
Title
10 metre Walk Test
Description
timed walk over 10 metres
Time Frame
Baseline, approximately 4 weeks after randomisation and 6 months
Other Pre-specified Outcome Measures:
Title
Client Services Receipt Inventory (CSRI)
Description
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.
Time Frame
Baseline and 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Nielsen
Organizational Affiliation
UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
The National Hospital for Neurology and Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27694498
Citation
Nielsen G, Buszewicz M, Stevenson F, Hunter R, Holt K, Dudziec M, Ricciardi L, Marsden J, Joyce E, Edwards MJ. Randomised feasibility study of physiotherapy for patients with functional motor symptoms. J Neurol Neurosurg Psychiatry. 2017 Jun;88(6):484-490. doi: 10.1136/jnnp-2016-314408. Epub 2016 Sep 30.
Results Reference
derived

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Feasibility Study of Physiotherapy for Functional Motor Symptoms

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