Conversion DisorderNCT02275000
Feasibility Study of Physiotherapy for Functional Motor Symptoms
A study testing 5 Day Physiotherapy Programme and Physiotherapy in people with Conversion Disorder, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conversion Disorder
- What is being tested?
- 5 Day Physiotherapy Programme and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
About this study
Official title: Randomised Feasibility Study of a Physiotherapy Programme for Patients With Functional Motor Symptoms (FMS).
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.
Read the 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.
- Conditions
- Conversion Disorder
- Being tested
- 5 Day Physiotherapy Programme, Physiotherapy
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 Day Physiotherapy ProgrammeOther
The experimental group will complete a 5 day physiotherapy programme consisting of education, movement retraining and a self management plan.
PhysiotherapyOther
Treatment as usual physiotherapy. The participant will be referred to their closest NHS outpatient neuro-physiotherapy service.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 5 Day physiotherapy programme at the National Hospital for Neurology and Neurosurgery, Queen Square, London UK. Receives: 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. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale of Change
Self rated 5 point Likert scale of change
Measured: Approximately 4 weeks after randomisation (this will be immediately after treatment for the experimental arm) and 6 months
Secondary outcomes (10)
Short Form 36
Measured: Baseline and 6 months
Hospital Anxiety and Depression Scale
Measured: Baseline, approximately 4 weeks after randomisation and 6 months
EQ-5D-5L
Measured: Baseline, approximately 4 weeks after randomisation and 6 months
Brief Illness Perception Questionnaire
Measured: Baseline, approximately 4 weeks after randomisation and 6 months
Work and Social Adjustment Scale
Measured: Baseline, approximately 4 weeks after randomisation and 6 months
Disabilities of the Arm, Shoulder and Hand (DASH)
self reported questionnaire of upper limb function
Measured: Baseline, approximately 4 weeks after randomisation and 6 months
Functional Mobility Scale
Scale of assistance required when walking 5, 50 and 500 metres.
Measured: Baseline, approximately 4 weeks after randomisation and 6 months
Psychogenic Movement Disorders Rating Scale (PMDRS)
Blind video analysis of movement
Measured: Baseline, approximately 4 weeks after randomisation and 6 months
Berg Balance Scale
Measured: Baseline, approximately 4 weeks after randomisation and 6 months
10 metre Walk Test
timed walk over 10 metres
Measured: Baseline, approximately 4 weeks after randomisation and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conversion DisorderStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Glenn Nielsen, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275000
- Sponsor's protocol ID
- 14/LO/0573
- Status last verified
- May 2015
- First submitted
- 20 Oct 2014
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27694498
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Feasibility Study of a Physiotherapy Programme for Patients With Functional Motor Symptoms (FMS).
- ClinicalTrials.gov ID
- NCT02275000
- Acronym / sponsor ID
- 14/LO/0573
- Conditions
- Conversion Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: 5 Day Physiotherapy Programme5 Day physiotherapy programme at the National Hospital for Neurology and Neurosurgery, Queen Square, London UK. |
| Treatment as usual | Active comparator | Other: PhysiotherapyParticipants are referred to their local neuro-physiotherapy service and if appropriate placed on a waiting list for inpatient rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 Day Physiotherapy ProgrammeThe experimental group will complete a 5 day physiotherapy programme consisting of education, movement retraining and a self management plan. | Other | Intervention |
| PhysiotherapyTreatment as usual physiotherapy. The participant will be referred to their closest NHS outpatient neuro-physiotherapy service. | Other | Treatment as usual |
Primary outcome
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
10 secondary outcomes
Short Form 36
Time frame: Baseline and 6 months
Hospital Anxiety and Depression Scale
Time frame: Baseline, approximately 4 weeks after randomisation and 6 months
EQ-5D-5L
Time frame: Baseline, approximately 4 weeks after randomisation and 6 months
Brief Illness Perception Questionnaire
Time frame: Baseline, approximately 4 weeks after randomisation and 6 months
Work and Social Adjustment Scale
Time frame: Baseline, approximately 4 weeks after randomisation and 6 months
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: Baseline, approximately 4 weeks after randomisation and 6 months
Functional Mobility Scale
Time frame: Baseline, approximately 4 weeks after randomisation and 6 months
Psychogenic Movement Disorders Rating Scale (PMDRS)
Time frame: Baseline, approximately 4 weeks after randomisation and 6 months
Berg Balance Scale
Time frame: Baseline, approximately 4 weeks after randomisation and 6 months
10 metre Walk Test
Time frame: Baseline, approximately 4 weeks after randomisation and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Derived from this study: PubMed 27694498Nielsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Nielsen principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 Day Physiotherapy Programme and Physiotherapy in people with Conversion Disorder, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02275000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.