The Effects of Robot-Assisted Gait Training Concurrent With Self-Observation Training on Balance, Gait, Cognitive Function in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gait ability
研究概览
简要总结
The aim of this study is to investigate the effects of robot-assisted gait training Concurrent with self-observation training on balance, gait, and cognitive function in stroke participants. The main question it aims to answer is:
Does robot-assisted gait training combined with self-observation improve balance abilities in stroke participants?
Participants will be
Group 1 Perform robot-assisted gait training combined with self-observation five times a week for four weeks.
Group 2 Perform robot-assisted gait training five times a week for four weeks.
All groups perform for 30 minutes per session.
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 (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have had a stroke for more than 6 months but less than 1 year
- •Functional Ambulation Category (FAC) ≥ 2
- •Able to walk 10 meters independently with or without an assistive device
- •Participants eligible for application of the robot (ANGEL LEGS M20, Anger Robotics)
排除标准
- •Inability to wear the robot due to open wounds or skin conditions
- •Severe cognitive impairment (MMSE-K < 10) or significant difficulty in communication due to language disorders
- •Spasticity of the paralyzed limb with a Modified Ashworth Scale (MAS) ≥ 2
- •High risk of fractures, such as osteoporosis
- •Severe cardiovascular or pulmonary diseases
- •Neurological disorders affecting gait function, such as Parkinson's disease or multiple sclerosis
结局指标
主要结局
Gait ability
时间窗: from enrollment to the end of treatment at 4 weeks
-10 meter walking test (10MWT) The walking speed is calculated by measuring the time (in seconds) takes for the subject to walk 10 meters. Instructed to walk a total of 14 meters at maximum speed, excluding the first 2 meters and the last 2 meters to account for acceleration and deceleration phases. Participants may use personal walking aids (cane, walker, etc.). -GAITRite system (CIR Systems Inc., Franklin, New Jersey, USA) Participants pass over an electronic gait mat to computationally measure temporal and spatial walking variables.
Balance ability
时间窗: from enrollment to the end of treatment at 4 weeks
\- Timed up and go test (TUG) Participants sit on a chair with armrests, rise upon hearing a starting signal, walk 3 meters, return, and sit back down. The speed of this task is measured. Participants may use usual walking aids (cane or walker) but should not receive physical assistance. \- Functional Reach Test (FRT) Participants stand against a wall with feet fixed vertically, arms raised to 90 degrees, reaching forward as far as possible while measuring the distance (in cm) from the tip of the third metacarpal bone.
次要结局
- Cognitive ability(from enrollment to the end of treatment at 4 weeks)