ISRCTN56136713已完成未知
A randomised controlled trial of specialist Physiotherapy for Functional Motor Disorder (Physio4FMD)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 355
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31638942 protocol (added 23/10/2019) Results article in https://pubmed.ncbi.nlm.nih.gov/38768621/ (added 22/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. New or returning patients presenting to participating outpatient neurology clinics and neurology inpatients
- •2. The patient has a clinically definite” diagnosis of FMD according to the Gupta and Lang diagnostic classification criteria (Gupta and Lang 2009)*
- •3. Aged 18 or over
- •4. Diagnostic investigations have come to an end
- •5. The patient is accepting of the intervention
- •6. Motor symptoms must be sufficient to cause significant distress or impairment in social, occupational or other important areas of functioning (subjectively described by the patient), independent of other comorbidities
- •* Gupta A, Lang AE. Psychogenic movement disorders. Curr Opin Neurol 2009;22:430–6. doi:10.1097/WCO.0b013e32832dc169
排除标准
- •1. The recruiting neurologist deems the patient to have severe psychiatric co-morbidity, including factitious disorder, self-harm, anxiety and depression, which would interfere with the patient’s ability to participate in physiotherapy**
- •2. The patient has an organic diagnosis which explains the majority of their symptoms or disability
- •3. pain, fatigue or dissociative seizures that would interfere with their ability to engage in the trial physiotherapy intervention
- •4. Disability to the extent that the patient requires assistance for toileting
- •5. The patient is unable to attend 9 sessions of physiotherapy over a 3 week period, within 6 weeks of initial neurology consultation
- •6. Ongoing unresolved compensation claim or litigation
- •7. The patient has no fixed address or is seeking rehousing through their council for disability access reasons
- •8. Unable to understand English sufficiently to complete questionnaires
- •9. The patient has a documented learning disability that prevents them from answering questionnaires independently
- •10. The patient lacks capacity to give consent
- •** The decision to exclude a patient due to psychiatric comorbidity is a clinical decision made by the neurologist, rather than a decision based on a screening tool or questionnaire. We believe that no single screening tool or questionnaire would serve this purpose (due to the range of potential psychiatric problems. Additionally, there is insufficient data on which to base cut-off scores to exclude patients on any particular questionnaire. The recruiting neurologists involved in the trial are consultants in neurology, selected for their experience in managing patients with FMD and patients with psychiatric comorbidity.
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