Feasibility and Efficacy of the Upper Limb Treatment With "Gloreha Aria" in the Hemiplegic Patients: a Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline of FMA-UE (Fugl-Meyer assessment upper extremity).
研究概览
简要总结
Stroke is one of the leading causes of death and disability and has been described as a worldwide epidemic (1). Stroke survivors are affected by impairments and limitations of cognitive, language, perceptual, sensory, and motor functions. After a stroke, patients can improve spontaneously within the first 3 months (2) and then more slowly in the following year. The first day, decreased oedema and partial reperfusion of the ischemic penumbra may possibly explain these phenomena, but the improvement of neurological deficit in the following weeks suggests plasticity phenomena and brain cortical reorganization (3). While most recovery is thought to be made in the first few weeks after stroke, patients may make improvements on functional tasks many months after having a stroke (4). Restoring arm and hand skill after a stroke remains challenging, even though stroke rehabilitation programs have proven partial efficacy Repetitive task training has been shown to be effective in some aspects of rehabilitation, such as improving walking distance and speed and improving upper limb function (5).
In this project, the investigators will use "Gloreha ARIA" (7) a new sensor-based therapy device designed for motor recovery of impaired upper limb Gloreha Aria offers specific programs that help patients to move arm, wrist and fingers. Therapists can customize therapy by focusing on a specific motor task.
详细描述
The hypothesis was that rehabilitation with this device could be not inferior in comparison with hands-on physiotherapy, in the reeducation of upper arm in the patient affected by stroke from cerebral ischemia or hemorrhage that had occurred ≤ 30 days before.
The principle purpose of this study will be to evaluate:
- The feasibility of this new device
- Efficacy in improving arm function abilities in the rehabilitation of patients with stroke in the sub-acute phase.
Post-stroke patients admitted for inpatient rehabilitation to the Neurological Rehabilitation will be screened for enrolment and randomized in a controlled trial.
All the patients will be informed about the aim and experimental procedures before enrolment, thus written informed consent will be obtained from all of them. Patients included in the study will be randomly assigned to intervention or control group according to simple randomization technique (computerized random numbers).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to exhibit first cerebral vascular disease with unilateral hemispherical lesion confirmed by CT scan or MRI;
- •to be sub-acute patients (less than 30 days from the cerebral vascular event);
- •being affected by upper limb paresis;
排除标准
- •unable to understand verbal instruction or motor commands;
- •unilateral neglect;
- •significant visual impairment;
- •unstable medical condition;
- •significant orthopedic limitation to the shoulder, elbow; wrist and hand;
- •upper arm peripherical nerve lesion;
- •neuromuscular or neurodegenerative diseases;
- •spasticity > 3 in according to the Modifies Ashworth Scale (3);
结局指标
主要结局
Change from baseline of FMA-UE (Fugl-Meyer assessment upper extremity).
时间窗: From date of randomization (T0) until the to the end of the study (T1) after an intervention lasting over a period of about 6 weeks, assessed after 30 rehabilitation sessions, lasting 30 min/ day each and performed 5 days/week.
Assessment of sensorimotor function.
次要结局
未报告次要终点