Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change from Baseline of Perimeter edema
研究概览
简要总结
The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.
详细描述
We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke.
We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a history of acute phase of stroke (less than 12 months post onset),
- •first stroke episode,
- •no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,
- •no contracture of the affected wrist or fingers (Modified Ashworth<3),
- •no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study,
- •for P-ROM patients, the absence of active hand movements,
- •for the A-ROM patients, the presence of active hand movements.
排除标准
- •unstable medical disorders,
- •active Complex Regional Pain Syndrome (CRPS),
- •severe spatial neglect,
- •cognitive problems.
结局指标
主要结局
Change from Baseline of Perimeter edema
时间窗: 1 day after the treatment
次要结局
- Change from Baseline of Visual analogue scale (VAS)(1 day after the treatment)
- Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)(1 day after the treatment)
- Change from Baseline of Range Of Motion (ROM)(1 day after the treatment)
- Clinical Global Impression (CGI)(1 day after the treatment)
研究者
Chiara Mulé
Physiatrist Physician
Habilita, Ospedale di Sarnico