Comparison of Robot Assisted Gait Training and Body Weight Supported Treadmill Training in Chronic Stroke Patients Using Gait Analysis and SEMG Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Gait analysis with 2D camera
研究概览
简要总结
The aim of our randomized controlled clinical trial was to analyze the effects of robotic-assisted gait training and body-weight-supported treadmill training on gait analysis parameters and lower extremity agonist and antagonist muscle activities in stroke patients and to compare their effectiveness in improving locomotor function. The main questions that the researchers aimed to answer are: What are the effects of robotic-assisted gait training and body-weight-supported treadmill training on gait analysis parameters in stroke patients? What are the effects of robotic-assisted gait training and body-weight-supported treadmill training on lower extremity agonist and antagonist muscle activities in stroke patients? What is the effectiveness of robotic-assisted gait training and body-weight-supported treadmill training in improving locomotor function in stroke patients? The patients included in the study were randomly divided into three groups: The first group received robotic-assisted gait training with RoboGait, the second group received body-weight-supported gait training on a treadmill with RehaWalk, and the third group received conventional walking training.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above
- •Chronic stage stroke (6 months - 2 years)
- •First stroke
- •Spasticity of Ashworth stage 2 or lower
- •Ability to follow commands
- •Ability to walk unsupported for more than 10 meters
- •No treatment received in the last month
排除标准
- •Severe osteoporosis
- •Unstable fracture
- •Excessive spasticity (Ashworth stage 3 and above)
- •Cognitive impairment
研究组 & 干预措施
RoboGait group
Robotic walking training 3 days a week, 30 minutes a day for 4 weeks
干预措施: RoboGait (Device)
RehaWalk group
Walking training on treadmill with body weight support for 30 minutes a day, 3 days a week for 4 weeks
干预措施: RehaWalk (Device)
Conventional Group
Conventional walking training for 30 minutes a day, 3 days a week for 4 weeks
干预措施: Conventional (Other)
结局指标
主要结局
Gait analysis with 2D camera
时间窗: Change from baseline kinematic parameters at the 4th week after the treatment
Kinematic parameters: Hip joint flexion range of motion degree in the swing phase in the sagittal plane, knee joint maximum flexion angle degree, ankle joint dorsiflexion range of motion degree
Surface Electromyography (sEMG)
时间窗: Change from baseline surface electromyography (sEMG) at the 4th week after the treatment
The average EMG (AEMG) amplitude and co-contraction indices (CCI) are calculated for the affected lower extremity's knee flexion and ankle dorsiflexion during the swing phase. CCI is calculated using the formula antagonistic muscle AEMG / (antagonistic muscle AEMG + agonistic muscle AEMG)
Pressure and Walking Analysis
时间窗: Change from baseline pressure and walking analysis at the 4th week after the treatment
The researchers examined the effects such as walking line length, single support line, forward and backward rollers and lateral symmetry indexes in the pressure analyses. In the gait analysis, walking speed, cadence, step length, step width, foot rotation angle, step duration, double support duration, stance phase, swing phase, single support phase, pre-swing phase, mid-swing phase, terminal swing phase, stance duration, swing duration, double phase, double step length and temporal symmetry index were evaluated. The temporal symmetry index was calculated using the following formula: Swing duration of the affected side of the patient / Swing duration of the unaffected side of the patient
次要结局
- The Functional Ambulation Scale (FAS)(Change from baseline FAS at the 4th week after the treatment)
- For lower extremity, the Fugl-Meyer Assessment (FMA-LE)(Change from baseline FMA-LE at the 4th week after the treatment)
- The 6-minute walk test (6MWT)(Change from baseline 6MWT at the 4th week after the treatment)
研究者
Füsun Ardıç
Professor Doctor
Pamukkale University