Efficacy Study of the Multidisciplinary Therapeutic Approach to the Quality of Life of Patients With Functional Movement Disorders and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Quality of Life in patients with functional movement disorders measured by the 36-Item Short Form Health Survey (SF-36)
研究概览
简要总结
Randomized-clinical trial of multidisciplinary approach versus psychoeducation in patients with functional movement disorders: impact to their quality of life and their caregivers' quality of life. Patients with functional movement disorders are randomized in two arms of a one-month treatment (physiotherapy + cognitive-behavioral therapy versus psychoeducational as sham intervention) with a 3-month and 5-month follow-up where the investigators will measure the change in the patients' and caregivers' quality of life. Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.
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
- Single (Investigator)
盲法说明
Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.
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
- •Diagnosis of Functional Movement Disorders (Espay and Lang, 2015)
- •Patients should be 18 years old or older and capable of giving consent to freely and willingly participate in the study.
- •Patients should be able to attend the one-month ambulatory regime and follow-up visits.
排除标准
- •Any condition that avoid the patient from giving free consent to participate in the study.
- •Any non-controlled psychiatric disorders
研究组 & 干预措施
Multidisciplinary therapeutic approach
- Diagnosis of Functional Movement Disorders by one of the PI (Movement Disorders Specialist).
- 12 physiotherapy sessions during one month (three 60-minute sessions per week) administered by a physiotherapist with experience in functional neurological disorders.
- 4 cognitive-behavioral therapy sessions during one month (one 60-minute intervention per week) administered by a psychologist with experience in cognitive-behavioral therapy.
干预措施: Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy) (Behavioral)
Psychoeducation
- Diagnosis of Functional Movement Disorders by one of the PI (Movement Disorders Specialist).
- 4 psychoeducational sessions (one 60-minute intervention per week) administered by a psychologist with experience in cognitive-behavioral therapy.
干预措施: Psychoeducation (Sham intervention) (Other)
结局指标
主要结局
Quality of Life in patients with functional movement disorders measured by the 36-Item Short Form Health Survey (SF-36)
时间窗: 3th-month and 5th-month follow-ups
Change in the patients' quality of life measured by changes in SF-36
Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ visual analogue scale
时间窗: 3th-month and 5th-month follow-ups
Change in the patients' quality of life measured by changes in EQ-5D-5L - the EQ visual analogue scale (EQ VAS).
Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ-5D descriptive system.
时间窗: 3th-month and 5th-month follow-ups
Change in the patients' quality of life measured by changes in EQ-5D-5L - EQ-5D descriptive system. The digits for the five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) can be combined into a 5-digit number that describes the patient's health state.
次要结局
- Quality of Life in caregivers of patients with functional movement disorders(3th-month and 5th-month follow-ups)
- Severity of functional neurological symptoms of patients with functional movement disorders measured by Clinical Global Impressions (CGI) Scale(3th-month and 5th-month follow-ups)
- Improvement of functional neurological symptoms of patients with functional movement disorders(3th-month and 5th-month follow-ups)
- Severity of functional neurological symptoms of patients with functional movement disorders(3th-month and 5th-month follow-ups)