The Effectiveness of Subacute Stroke Patients Receiving Robotic Assisted Gait Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Gait Speed
研究概览
简要总结
The goal of this randomized controlled trial is to learn about the effects of Robotic Assisted Gait Training (RAGT) combined with traditional physical therapy in subacute stroke patients. The main question it aims to answer is:
- Does RAGT combined with traditional physical therapy improve gait and functional performance in subacute stroke patients compared to traditional physical therapy alone? Participants who are subacute stroke patients will be randomly assigned to receive either both RAGT and traditional physical therapy or only traditional physical therapy. Their gait and functional performance will be assessed during the study period.
详细描述
The sequelae of stroke have a significant impact on patients' physical functions and quality of life. Although traditional physical therapy can help some patients regain function, its effectiveness is often limited. Therefore, exploring new rehabilitation technologies has become one of the key tasks in the medical field. Robotic Assisted Gait Training (RAGT) is an emerging technology that provides high-intensity and repetitive gait training, making it particularly suitable for patients in the post-stroke rehabilitation phase. Recent studies have shown that RAGT can significantly improve gait abilities in stroke patients, including walking speed and functional performance. Therefore, this study will adopt a randomized controlled trial design, recruiting 20 subacute stroke patients who will be randomly assigned to either a group receiving both RAGT and traditional physical therapy or a group receiving only traditional physical therapy. The study will compare differences in gait and functional performance between the two groups during the rehabilitation process, aiming to provide a foundation for future personalized and precision treatment plans.
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
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stroke (ischemic or hemorrhagic) confirmed by medical imaging.
- •Subacute phase of stroke (onset within 1 to 3 months).
- •Moderate to good standing balance ability.
- •Sufficient cognitive ability to understand the study and follow instructions.
- •Able to participate in rehabilitation training during the study period.
排除标准
- •Body weight over 90 kg.
- •Presence of other neurological disorders.
- •Severe cardiovascular disease or other health conditions affecting mobility.
- •Significant lower limb pain, joint contracture, or spasticity (Modified Ashworth Scale score > 3) that impairs walking.
- •Diagnosed with cardiopulmonary disease that contraindicates exercise training.
- •Cognitive impairment that prevents understanding of training instructions or completion of questionnaires.
- •Inability to complete the rehabilitation training protocol.
结局指标
主要结局
Gait Speed
时间窗: Baseline and after 4 weeks of intervention
Gait speed will be calculated as distance divided duration. A timer will collect the duration (seconds, s) while subjects walk 3 meters (m, distance). The gait speed showed as (m/s) directly.
Step Length
时间窗: Baseline and after 4 weeks of intervention
Objective assessment of gait performance using two inertial sensors attached to the shoes. Measures include step length (meters)
Toe Clearance
时间窗: Baseline and after 4 weeks of intervention
Objective assessment of gait performance using two inertial sensors attached to the shoes. Measures include toe clearance (meters).
Timed Up and Go Test (TUG)
时间窗: Baseline and after 4 weeks of intervention
Assesses functional mobility and fall risk. Participants stand up from a chair, walk 3 meters, turn around, return, and sit down. The time taken to complete the task is recorded.
Functional Independence Measure (FIM)
时间窗: Baseline and after 4 weeks of intervention
Evaluates the level of a participant's independence in daily activities. The FIM includes 18 items across motor and cognitive domains, each scored from 1 (total assistance) to 7 (complete independence), with a total score range of 18 to 126.
次要结局
- Berg Balance Scale (BBS)(Baseline and after 4 weeks of intervention)
- 30-Second Chair Stand Test (30-CST)(Baseline and after 4 weeks of intervention)
- Surface Electromyography (sEMG)(Baseline and after 4 weeks of intervention)
- Short Form-12 Health Survey (SF-12)(Baseline and after 4 weeks of intervention)