Clinical and Social-economic Impact Assessment of Robot-assisted Rehabilitation of the Upper Limb in Acute and Subacute Post-stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Frenchay Arm Test (FA-T)
研究概览
简要总结
The goal of this study is to determine if robot aided rehabilitation therapy can be equivalent to or more effective than conventional rehabilitation therapy at promoting functional recovery of the paretic upper limb in acute and subacute stroke patients.
详细描述
The study aims to test a robotic rehabilitation protocol which involves the use of a robotic device (NeReBot) as an alternative to the conventional rehabilitation treatment. NeReBot is a 3-degree-of-freedom robotic device, which can be programmed by the therapist to perform repetitive assistive movements (flexion and extension, adduction and abduction, pronation and supination, circular) of the upper limb (shoulder and elbow), combined with a visual and acoustic display. Acute and subacute stroke patients (≤20 days post-stroke) will be randomized into two groups with a procedure by a computer program: the experimental group (EG) and the control group (CG). Both groups will receive a total daily treatment time of 120 minutes for five days a week and for five weeks. The EG will perform the conventional functional rehabilitation (proprioceptive exercises, verticalization, gait training, paretic hand and wrist mobilization, without mobilizing the proximal paretic arm) and occupational therapy for 80 minutes a day, while the proximal paretic arm will be treated by NeReBot for 40 minutes a day. For the CG, NeReBot therapy is substituted by 40 minutes of conventional mobilization of the proximal paretic arm by the therapist.
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)
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
- •recent unilateral single stroke (ischemic or hemorrhagic) verified by brain CT or MRI;
- •sufficient cognitive and language skills to understand the instructions of the operator (assessed by Modified Mini-Mental State Examination > 21);
- •patients with upper limb paralysis (Motor Power score between 8 and 12);
- •written informed consent signed by the patient (or an authorized representative).
排除标准
- •cardiovascular instability (severe uncontrolled hypertension, severe coronary artery disease, etc.) or orthopedic, or neurological conditions;
- •presence of multiple cerebrovascular lesions (usually the result of many ischemic episodes in the past);
- •early appearance of marked spasticity (≥ 3 according to Ashworth Scale);
- •joint pain or limited joint range of motion (ROM) of the upper limb that results in the inability to complete the protocol;
- •severe neuropsychologic impairment (global aphasia, severe attention deficit or neglect), affecting the patient's ability to follow instructions;
结局指标
主要结局
Frenchay Arm Test (FA-T)
时间窗: 7 months
Franchey Arm Test (FA-T) evaluates five activities of daily living: lifting and replacing of a glass, drawing a line with the use of a ruler, combing the hair, lifting and replacing of a cylinder \[5 cm long\], removing of a sprung clothes peg from a dowel and replacing it; 0 = worst score; 5 = best score).It reflects both hand and arm functions.
Motor-Functional Independence Measure (m-FIM)
时间窗: 7 months
Motor-Functional Independent Measure (m-FIM) is a test to measure improvements in basic motor ADL, outcomes and the degree of self-care. The motor-FIM is a subsection of Functional Indipendence Measure that is an ordinal scale that assesses severity of motor disability, composed of 13-item motor subscale (including self-care, sphincter control, mobility, locomotion) with a scoring ranges between 13 and 91; each item envisages 7 levels of performance independence (7 is total independence, 1 is total dependence or unassessable).
Fugl-Meyer (FM-SEC and FM-WH)
时间窗: 7 months
Fugl-Meyer (FM) assessment for measures of the motor impairment of the upper-limb; the test includes items related to movements of the shoulder, elbow, forearm (proximal arm), and wrist and hand (distal arm). The total scores range between 0 and 66. We considered the shoulder/elbow and coordination subsections (FM-SEC = 42/66 items) and the wrist/hand subsection (FM-WH = 24/66 items).
次要结局
- Fatigue Severity Scale (FSS)(7 months)
- Upper-Motricity Index (upMI)(7 months)
- Short Form 12(7 months)
- Functional Independent Measure (FIM)(7 months)
- Medical Research Council (MRC deltoid, biceps, triceps, wrist flexor, wrist extensor)(7 months)
- Box and Block Test(7 months)
- Modified Ashworth Scale (MAS)(7 months)
- Trunk Control Test (TCT)(7 months)