Effectiveness of a Virtual Reality Rehabilitation in Stroke Patients With Sensory-motor and Proprioception Upper Limb Deficit: a Study Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- The Fugl-Meyer Assessment (FMA)
研究概览
简要总结
Introduction: Stroke is the second leading cause of death in Europe. In the case of stroke survival (almost 70%), only 25% of patients recover completely, while the remaining 75% will undergo a rehabilitation phase that varying from months to years. The main consequences of a stroke include motor disability of the upper limbs, which involves a partial or complete inability to move the right or left limb, depending on the damaged hemisphere. Furthermore, the motor deficit distorts the proprioception of the body and the embodiment ability of the injured limb. This could be rehabilitated through the paradigm of body illusion that modulates the motor rehabilitation. The present protocol aims to investigate the effectiveness of a Virtual Reality system for sensorimotor and proprioception upper limb deficit compared to a traditional upper limb rehabilitation program.
Method: This study has a randomized and controlled design with control and experimental groups, a 1:1 allocation ratio, and 4 measurement times: pre-intervention, immediately after the intervention, and two follow-ups (at 6 and 12 months). The inclusion criteria are: (a) Being 18 to 85 years old, both males and females; (b) Suffering from ischemic or hemorrhagic stroke; (c) The stroke event must have occurred from two to eighteen months before recruitment; (d) Patients must have moderate to severe upper limb motor deficit, and the alteration of sensorimotor and proprioception abilities of the injury upper limb; (e) Patients must understand and sign the written consent for enrolment. The rehabilitation last four weeks with three sessions per week at Bellaria Hospital of Bologna (Italy). The VR protocol uses two types of technology: immersive and non-immersive, and the control group follow the traditional rehabilitation program.
Ethics and dissemination: The protocol was accepted by the Local Ethics Committee (ASL_BO n. 0115481) and the clinical trial was promoted.
详细描述
Randomized control trial with active groups.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 to 85 years old (both male and female)
- •Suffering from ischemic or hemorrhagic stroke
- •Time since the stroke from 2 to 18 months before recruitment
- •Severe upper limb motor deficit established by a score of ≤ 80 on the Motricity Index
- •Alteration of sensorimotor and proprioception abilities of the injury upper limb (failure in 3 proofs up to 4 of the Thumb Location Test)
- •Understand and sign the written consent for enrolment
排除标准
- •Severe cognitive and behavioral disorders or a state of confusion defined by temporal and/or spatial disorientation detected during an ordinary conversation (evaluate through 4AT)
- •Severe upper limb motor deficit (score Motricity Index Scale: gripper <11, elbow flexion <14, shoulder abduction <14)
- •Verbal comprehension ability (score <2 at Token Test)
- •Severe spatial neglect ( score of >3 at Barrage test)
结局指标
主要结局
The Fugl-Meyer Assessment (FMA)
时间窗: 2 years approximately.
The primary outcome measures will be the Fugl Meyer (Platz et al., 2005) for motor ability. The Fugl-Meyer includes 33 items to evaluate upper extremity motor impairment and is scored between 0 and 2 (0 = unable, 1 = partly able, and 2 = fully able to complete movement) with a total score range of 0-66. The assessment will be performed before treatment (T1), after the conclusion of the treatment (T2), and after 6 months as a follow-up (T3).
次要结局
- "Body's Proprioceptive ability"(2 years approximately.)
- "Self-efficacy"(2 years approximately.)
- "Limb ability"(2 years approximately.)
- "Arm's Proprioceptive ability"(2 years approximately.)
- "Autonomy level"(2 years approximately.)
研究者
Sara Ventura
Researcher
University of Bologna