Feasibility Study of Physiotherapy for Functional Motor Symptoms

NCT ID: NCT02275000

Last Updated: 2016-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-01-31

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 -

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.

Conditions

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Conversion Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

5 Day Physiotherapy Programme

Intervention Type OTHER

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

Treatment as usual

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

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type OTHER

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

Interventions

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5 Day Physiotherapy Programme

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

Intervention Type OTHER

Physiotherapy

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn Nielsen

Role: PRINCIPAL_INVESTIGATOR

UCL

Locations

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The National Hospital for Neurology and Neurosurgery

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 27694498 (View on PubMed)

Other Identifiers

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14/LO/0573

Identifier Type: -

Identifier Source: org_study_id

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