Randomised Feasibility Study of a Physiotherapy Programme for Patients With Functional Motor Symptoms (FMS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinical Global Impression Scale of Change
研究概览
简要总结
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.
详细描述
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 -
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Clinical Global Impression Scale of Change
时间窗: 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
次要结局
- Disabilities of the Arm, Shoulder and Hand (DASH)(Baseline, approximately 4 weeks after randomisation and 6 months)
- 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)
- Functional Mobility Scale(Baseline, approximately 4 weeks after randomisation and 6 months)
- Psychogenic Movement Disorders Rating Scale (PMDRS)(Baseline, approximately 4 weeks after randomisation and 6 months)
- Berg Balance Scale(Baseline, approximately 4 weeks after randomisation and 6 months)
- 10 metre Walk Test(Baseline, approximately 4 weeks after randomisation and 6 months)