NCT07037849招募中不适用
Effects of Control Strategies in Wearable Lower Limb Rehabilitation Robots
Eighth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年10月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in 10 Meter Walk Test from baseline gait speed
研究概览
简要总结
Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers) in a rectangular hospital corridor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke patients aged between 18 and 75 years. Patients who are medically stable and able to stand and walk independently for at least 10 meters during rehabilitation.
- •Stroke event occurred at least 3 months ago Patients with impaired lower limb motor function but with some degree of muscle activity in the lower extremities.
- •Patients without severe cognitive impairment and capable of understanding and following the treatment protocol.
- •Patients without severe balance or coordination disorders, able to maintain balance and perform gait training with assistive devices.
- •Patients without lower limb fractures or other serious skeletal issues affecting the lower limbs.
- •Patients without severe cardiovascular or other serious illnesses and able to tolerate the intensity and duration of rehabilitation therapy.
- •Patients willing to participate in the study and able to provide written informed consent.
排除标准
- •Severe cognitive impairment that prevents the patient from understanding or complying with the treatment protocol.
- •Severe balance or coordination disorders that prevent the patient from maintaining balance and participating in gait training, even with assistive devices.
- •Other serious motor disorders, such as abnormal muscle tone or ataxia, which may interfere with the effectiveness of rehabilitation therapy.
- •Active cardiovascular disease or other serious systemic illnesses that may affect the patient's safety or treatment outcomes.
- •Lower limb fractures or other serious skeletal issues that may impact the suitability and safety of robot-assisted rehabilitation therapy.
- •Patients currently receiving other rehabilitation or experimental treatments. Patients with skin ulcers, infections, or other severe skin conditions that may interfere with the use and application of robotic devices.
- •Unexplained discomfort or pain symptoms that may limit the patient's ability to participate in rehabilitation therapy.
- •Failure to meet other specific inclusion criteria outlined in the study protocol.
研究组 & 干预措施
Robot gait training group
Experimental
During this study, we will explore which control strategy: Aware Hip Knee Coupling Control (AHKC), Passive control (PC), or fixed compliance control (FCC) may be optimal for post-stroke subjects
干预措施: Robot-assisted overground gait training (Device)
结局指标
主要结局
Change in 10 Meter Walk Test from baseline gait speed
时间窗: Baseline, immediately after intervention
Gait speed will be assessed by instructing participants to walk at their maximum safe speed. Each participant will start 1 meter before the designated start line and continue walking until 1 meter past the finish line. The time taken to traverse the measured distance will be recorded using a stopwatch to the nearest one hundredth of a second.
次要结局
- Change scores of Lower Extremity Fugl-Meyer Assessment (FMA-LE)(Baseline, immediately after intervention)
研究者
研究点 (1)
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