The Effect of EMG-Driven Exoskeleton Robotic Rehabilitation on Improving Hand Functions in Acute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Upper Extremity Assessment:
研究概览
简要总结
The advantage of the EMG-driven exoskeletons is that patient's own muscle power known as Residual Muscle Power is used to move the extremity while many other robotic devices work and drive impaired limb based on machine directed force. However, it is not clear which group of patients are suitable for EMG driven exoskeletons use and there has not been any established treatment protocol.
The aims of the study are 1- to investigate the effectiveness of the EMG-driven exoskeleton for hand rehabilitation in patients with acute stroke. 2- to understand which group of the patients may give the best response to the EMG-driven technology and how should be the treatment protocol designed.
详细描述
Improving the rehabilitation outcome of the upper extremity in stroke patients has been an ongoing challenge in the rehabilitation field. Up to 85% of stroke survivors experience a certain degree of paresis of the upper limb at the onset and only 20% to 56% of survivors regain complete functional use of the affected upper limb despite the therapeutic interventions in first 3 months . Recovery of upper limb function is generally slower and non-complete.
To support and speed up a recovery process, there are many robotic devices currently used in the stroke units. Unlike one-on-one treatment applied by clinicans, robotic devices can provide repetitive, task oriented movements,with greater intensity, stimulating and engaging environment for user, hence alleviating the labour-intensive aspects of hands-on conventional therapy. There are a number of complex robotic devices that have been developed over the last two decades to assist upper arm training in rehabilitation.
Using EMG driven exoskeleton, commercially known as the Hand of Hope (HOH), has been shown its efficacy to improve patient's grip and pinch ability, muscle coordination and improve functional daily living tasks in patients even after 3,4,8,10 and 14 years after onset of the stroke. In addition to continuous investigation efforts needed to be spent, there has not been established any treatment protocol using EMG-driven exoskeletons. Since Stroke patients need to be focused on their own residual muscle power, clear indications for EMG-driven exoskeletons i.e., Hand of Hope, need to be established.
An investigation designed to highlight all these points will make an important contribution to the therapeutic approach using EMG-driven hand robotics for the hand rehabilitation after stroke.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having ischemic stroke history within last 4 weeks
- •Being at the age 18 and older than 18
- •Providing a sitting balance during the robot training (maximum 1 hour with preparation time)
- •Understanding and performing simple commands
- •Full range of motion in MCP, PIP and DIP
- •MAS < 3 for finger flexors and extensors
- •Participants who agree to participate in the study
排除标准
- •Recurrent stroke
- •Other neurologic or orthopedic problems that may affect to upper extremity functions
- •Hemispatial neglect (will be diagnosed by Line bisection test and The star cancellation test)
- •Refused treatment, non-cooperation
- •MAS ≥ 3 (MAS will be measured every week during the treatment period)
结局指标
主要结局
Fugl-Meyer Upper Extremity Assessment:
时间窗: Change from pre-interventional Fugl-Meyer Upper Extremity score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.
Fugl-Meyer assessment was first used in 1975 to assess post-stroke physical performance. 33-item upper extremity subscale of the Fugl-Meyer scale evaluates movements, coordination/speed and pain in the shoulder, elbow, forearm. The highest score for the upper extremity is 66.
次要结局
- Range of motion measurement (ROM)(Change from pre-interventional ROMs at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.)
- Action Research Arm Test (ARAT)(Change from pre-interventional ARAT score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.)
- Motor Activity Log(Change from pre-interventional Motor Activity Log score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.)
- Force and EMG measurement with the testing device(Change from pre-interventional force and EMG measurement with the testing device at the end of the 5th session, 10th session and 15 session intervention that will be performed at the last session of each week at a total of 3 weeks.)
- Manuel muscle testing(Change from pre-interventional Manuel muscle testing scores at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.)
- hand dynamometer(Change from pre-interventional grip strentgh at the end of the 15 session interventions that will be performed 5 days in a week at a total of 3 weeks.)
研究者
Dilber Karagozoglu Coskunsu
Principal Investigator
Bahçeşehir University