Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02275000
Other study ID # 14/LO/0573
Secondary ID
Status Completed
Phase N/A
First received October 20, 2014
Last updated May 13, 2016
Start date September 2014
Est. completion date January 2016

Study information

Verified date May 2015
Source University College, London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Institute for Health Research
Study type Interventional

Clinical 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.


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 -

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
5 Day Physiotherapy Programme
The experimental group will complete a 5 day physiotherapy programme consisting of education, movement retraining and a self management plan.
Physiotherapy
Treatment as usual physiotherapy. The participant will be referred to their closest NHS outpatient neuro-physiotherapy service.

Locations

Country Name City State
United Kingdom The National Hospital for Neurology and Neurosurgery London

Sponsors (2)

Lead Sponsor Collaborator
University College, London National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Client Services Receipt Inventory (CSRI) 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. Baseline and 6 month follow up No
Primary 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 No
Secondary Short Form 36 Baseline and 6 months No
Secondary Hospital Anxiety and Depression Scale Baseline, approximately 4 weeks after randomisation and 6 months No
Secondary EQ-5D-5L Baseline, approximately 4 weeks after randomisation and 6 months No
Secondary Brief Illness Perception Questionnaire Baseline, approximately 4 weeks after randomisation and 6 months No
Secondary Work and Social Adjustment Scale Baseline, approximately 4 weeks after randomisation and 6 months No
Secondary Disabilities of the Arm, Shoulder and Hand (DASH) self reported questionnaire of upper limb function Baseline, approximately 4 weeks after randomisation and 6 months No
Secondary Functional Mobility Scale Scale of assistance required when walking 5, 50 and 500 metres. Baseline, approximately 4 weeks after randomisation and 6 months No
Secondary Psychogenic Movement Disorders Rating Scale (PMDRS) Blind video analysis of movement Baseline, approximately 4 weeks after randomisation and 6 months No
Secondary Berg Balance Scale Baseline, approximately 4 weeks after randomisation and 6 months No
Secondary 10 metre Walk Test timed walk over 10 metres Baseline, approximately 4 weeks after randomisation and 6 months No
See also
  Status Clinical Trial Phase
Completed NCT00971360 - Cytokine Levels in Conversion Disorder N/A
Completed NCT00835627 - Treatment Trial for Psychogenic Nonepileptic Seizures Phase 4
Active, not recruiting NCT01422278 - Rehabilitation of Conversion Gait Disorder Phase 1/Phase 2
Active, not recruiting NCT03441867 - Neuroimaging Biomarker for Seizures N/A
Completed NCT03398070 - Neuroimaging Biomarkers of Prognosis in Motor Functional Neurological Disorders
Completed NCT02102906 - TMS and Attentional Bias in Functional Motor Disorder N/A
Completed NCT02325544 - Comparing Different Treatments in Reducing Dissociative Seizure Occurrence N/A
Terminated NCT02764476 - Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder N/A
Recruiting NCT05323344 - Metacognitive Therapy and Neuro-physiotherapy as a Treatment for Functional Movement Disorders N/A
Recruiting NCT04097184 - Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Motor Conversion Disorder Patients N/A
Completed NCT05219006 - Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures N/A
Completed NCT02329626 - Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder
Recruiting NCT05943652 - Observational Study on "Functional Overlay" in Patients With Movement Disorders
Completed NCT00159965 - Treatments for Psychogenic Nonepileptic Seizures (NES) Phase 4
Completed NCT05305014 - Contribution of Inflammation and Neuronal Integrity Markers in Patients With First-episode Conversive Motor Disorder