Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Change from National Institutes of Health Stroke Scale (NIHSS)
研究概览
简要总结
Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.
详细描述
The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •acute phase of stroke
- •first stroke episode.
- •no history of peripheral nerve injury or musculoskeletal disease
- •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 prior to the start of this study.
- •paralysis of the wrist and fingers
排除标准
- •unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems.
- •scored greater than 4 points on the Beck Depression Inventory (BDI)
- •more than 30 points in the State Trait Anxiety Inventory (STAI)
结局指标
主要结局
Change from National Institutes of Health Stroke Scale (NIHSS)
时间窗: baseline, immediately post-intervention (3 weeks).
次要结局
- Change from Modified Ashworth Scale (MAS)(baseline, immediately post-intervention)
- Change from Visual analogue scale (VAS)(baseline, immediately post-intervention (3 weeks).)
- Change from Barthel Index (BI)(baseline, immediately post-intervention (3 weeks).)
- Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)(baseline, immediately post-intervention (3 weeks).)
研究者
Jorge Hugo Villafañe, PhD
Researcher
Fondazione Don Carlo Gnocchi Onlus