Robotic Assisted Task-Oriented Rehabilitation of Upper Limb for Chronic Stroke Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Assessment (FMA( Score
研究概览
简要总结
The aim of this study is to evaluate the effects of an assisted rehabilitation treatment through a robotic exoskeleton device on the functional recovery in a group of patients with hemiparesis from lesion of the first motor neuron (post-stroke), compared with a group of patients subjected to a conventional rehabilitation treatment. The patients enrolled in the study are chronic stroke injured with right hemiparesis of moderate to severe degree, by the system injury pyramid, never undergoing rehabilitation treatment with robots.
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
- •diagnosis of a first-ever left hemisphere ischemic or hemorrhagic stroke at least 6 months prior to entry into the study;
- •minimum ability for shoulder humeral elevation;
- •upper-extremity motor function Fugl-Meyer (FM) score ≥ 15(out of 66);
- •absence of neurological or muscular disorders that interfere with neuromuscular function;
- •absence of severe cognitive deficits that would limit patients' ability to complete the study;
- •minimum score of 2 in the Modified Ashworth Scale;
- •not participating in any experimental rehabilitation or drug studies at the same time
- •no previous experience with robotic treatments.
排除标准
- 未提供
研究组 & 干预措施
Conventional treatment
The conventional treatment arm was conducted according to a set of exercises that were specifically designed in order to match the robotic treatment. Patients received both physical therapy (PT) and occupational therapy (OT) session, administered by the physiotherapists of the hospital. The therapist will provide a specific conventional treatment comparable with the robotic treatment in terms of session time and therapeutic goals.
Robotic treatment
The patients enrolled in the robotic arm are going to be undergone a series of passive, assisted and active mobilization in upper limb task-oriented exercises implemented in 3d virtual environments. Briefly speaking, these tasks promote the upper arm multi-joints coordination during the execution of reaching movements and grasping actions of fixed virtual objects displaced in the space.
干预措施: Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS) (Device)
结局指标
主要结局
Change in Fugl-Meyer Assessment (FMA( Score
时间窗: baseline and 6 weeks
The null hypothesis tested in this study was the change in motor function domain of the upper extremity portion of the Fugl-Meyer assessment in the Robotic Group (Robotic Treatment) would be the same as the one obtained by the Control Group (Conventional Treatment). The FMA outcome is further divided and analyzed in terms of sub-items. In particular, the motor FMA score is divided into proximal (shoulder and elbow movement, 36 points) and distal (hand and wrist movement, 24 points) sub-items.
次要结局
- Functional scale: Bimanual Activity Test (BAT)(baseline and 6 weeks)
- Modified Ashworth (MA) scale(baseline and 6 weeks)
- Robotic kinesiological assessment of movement: Execution Time(At end of each session, during 6 weeks of enrollment in treatment)
- Robotic kinesiological assessment of movement: Smoothness index(At end of each session, during 6 weeks of enrollment in treatment)
研究者
Antonio Frisoli
Prof, Office of Research and Development
Scuola Superiore Sant'Anna di Pisa