NCT02275000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

October 20, 2014

Last Update Submit

May 13, 2016

Conditions

Conversion Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • Short Form 36

    Baseline and 6 months

  • Hospital Anxiety and Depression Scale

    Baseline, approximately 4 weeks after randomisation and 6 months

  • EQ-5D-5L

    Baseline, approximately 4 weeks after randomisation and 6 months

  • Brief Illness Perception Questionnaire

    Baseline, approximately 4 weeks after randomisation and 6 months

  • Work and Social Adjustment Scale

    Baseline, approximately 4 weeks after randomisation and 6 months

  • +5 more secondary outcomes

Other Outcomes (1)

  • Client Services Receipt Inventory (CSRI)

    Baseline and 6 month follow up

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: 5 Day Physiotherapy Programme

Treatment as usual

ACTIVE COMPARATOR

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

Other: Physiotherapy

Interventions

5 Day Physiotherapy ProgrammeOTHER

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

Intervention
PhysiotherapyOTHER

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

Treatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 27694498DERIVED

MeSH Terms

Conditions

Conversion Disorder

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Glenn Nielsen

    UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 27, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 16, 2016

Record last verified: 2015-05

Locations

GB(1)