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Completed

NCT Number: NCT02275000

Feasibility Study of Physiotherapy for Functional Motor Symptoms

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5 Day Physiotherapy Programme

Other

The experimental group will complete a 5 day physiotherapy programme consisting of education, movement retraining and a self management plan.

Physiotherapy

Other

Treatment as usual physiotherapy. The participant will be referred to their closest NHS outpatient neuro-physiotherapy service.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2014
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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