Exoskeleton-assisted Upper Limb Rehabilitation After Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
In recent studies, it has been observed that robotic devices make a positive contribution to motor recovery and the activities of daily living. However, studies about the effects of stroke rehabilitation with robotic devices are limited.
This study aimed to investigate the effect of upper extremity robotic rehabilitation on motor function and quality of life in stroke patients.
详细描述
Stroke survivors have difficulties in participating in activities of daily living due to functional disabilities. The majority of patients after stroke need rehabilitation to gain independence in daily life as the first target. Therefore, different treatment approaches are used in stroke rehabilitation.
The use of technology in stroke rehabilitation has become very common in recent years. Robotic devices used in rehabilitation enhance the healing process by giving patients more intensive and task-oriented exercises. A lot of systematic and meta-analysis studies have shown that robot-assisted devices provide positive motor recoveries, especially in the treatment of upper extremities. However, the optimal timing, duration, and dose of robotic rehabilitation that should be applied after stroke remain uncertain.
In the light of this information, this study examines the effects of the robotic device produced for upper limb rehabilitation on daily life activities and motor function.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having ischemic or hemorrhagic stroke history
- •Being at the age between 40 and 85
- •MAS (Modified Ashworth Scale) < 3 for upper extremity
- •At least 6 months after stroke
- •Participants who agree to participate in the study
排除标准
- •Cardiovascular weakness (severe hypertension, coronary artery disease)
- •Mini-Mental State Examination score < 24
- •Recurrent stroke
- •Having other orthopedic and neurologic conditions that may affect upper extremity movement
- •Having behavioral and cognitive problems
结局指标
主要结局
Modified Ashworth Scale
时间窗: before treatment and at six weeks of the beginning of the treatment
Modified Ashworth Scale is used for measuring the spasticity of upper extremity skeletal muscle. The Modified Ashworth Scale (MAS) is scored from 0 to 5 to measure the resistance encountered when performing passive muscle stretching. The lowest score is 0 (no spasticity) and the highest score is 5 (severe spasticity).
Fugl-Meyer Upper Extremity Assessment
时间窗: before treatment and at six weeks of the beginning of the treatment
Fugl-Meyer Upper Extremity Assessment is an index to assess physical performance in individuals who had a stroke. This index consists of 33 items. Each item scored between 0 and 2. The highest score for the upper extremity is 66.
次要结局
- Nottingham Extended Activities of Daily Living Scale(before treatment and at six weeks of the beginning of the treatment)
- Upper Extremity Motor Activity Log(before treatment and at six weeks of the beginning of the treatment)
研究者
iremakgun
Physiotherapist
Marmara University