Effectiveness of Immersive Virtual Reality Rehabilitation Program to Reduce Symptoms Severity and Improve Quality of Life in Patients With Functional Motor Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score
研究概览
简要总结
The study aims to demonstrate the effectiveness and superiority of a 5-day immersive VR-rehabilitation treatment versus a 5-day conventional rehabilitation treatment in reducing FMDs symptoms severity, assessed by the Simplified Functional Movement Disorders Rating Scale (S- FMDRS).
详细描述
This is a single-blind, randomized controlled trial to evaluate the superiority of immersive VR distractors combined with graded physical exercises over conventional rehabilitation (without any VR distractors) to reduce FMDs symptoms and improve gait and balance. Patients will be randomized to receive the experimental training (VRG) or the control training (CRG) (allocation ratio 1:1). The primary and secondary outcomes will be measured by the same examiner before (T0), at the end of the treatment (T1), and at three-month follow-up after the end of the treatment (T2). The test order will be the same across all evaluation sessions. The examiner will be blinded to group assignments.
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 (Outcomes Assessor)
盲法说明
An examiner blinded to group allocation will assess all patients. To keep blindness, the examiner will not ask for information about the treatment to the patients or the caregivers, and this last will be instructed not to give any extra information outside of the examiner's questions.
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
- •were: established diagnosis of FMDs, age ≥ 18 years, and acceptance of the diagnosis.
排除标准
- •were: prominent dissociative seizures, prominent cognitive and/or physical impairment that precluded signing the informed consent form for study participation based on clinical judgment, incomplete assessment, and questionnaire because of language comprehension difficulties.
结局指标
主要结局
Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score
时间窗: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
Objective-rated validated scale to rate the duration and severity of functional motor symptoms (range: 0-54; higher = worse).
次要结局
- Change in the Multidimensional Fatigue Inventory Scale (MFI-20) score(Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).)
- Change in sway area (mm2)(Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).)
- Change in the Beck Depression Inventory (BDI-II) score(Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).)
- Change in the Clinical Global Impression (CGI) score(Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).)
- Change in Swing time (%)(Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).)
- Change in Stride length (cm)(Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).)
- Change in the Brief Pain Inventory (BPI) score(Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).)
- Change in gait speed (cm/sec)(Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).)
- Change in total excursion path (mm)(Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).)
- Change in the Beck Anxiety Inventory (BAI) score(Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).)
- Change in the 12-item Short-Form Health Survey (SF-12) score(Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).)
- Change in velocity of Cop displacement in the anteroposterior directions (mm/s)(Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).)
- Change in Stride time (s)(Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).)
- Change in velocity of Cop displacement in the mediolateral directions (mm/s)(Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).)
- Change in the Toronto Alexithymia Scale (TAS-20) score(Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).)
研究者
Marialuisa Gandolfi
MD, PhD
Universita di Verona