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临床试验/NCT07760116
NCT07760116已完成不适用

Comparison of the Therapeutic Effects Between Traditional and Brain-Computer Interface-Controlled Exoskeleton Gait Training in Post-Stroke Patients: A Randomized Comparative Study

Taichung Veterans General Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Change in 6-Minute Walk Test (6MWT) distance

研究概览

简要总结

After a stroke, many people have trouble walking. One way to practice walking again is with a wearable robot, called an exoskeleton, that supports the legs and guides them through a walking pattern. In most systems, a therapist or a sensor decides when each step starts.

This study looked at whether it helps to let a person's own brain activity start each step instead. Sensors placed on the scalp recorded brain signals. A computer read these signals and told the robot when to take a step. This way of controlling a device is called a brain-computer interface.

People who had a stroke within the past year took part. They were placed by chance into one of two groups. One group practiced walking with the robot in the usual way. The other group practiced with the robot controlled by their own brain signals. Both groups trained twice a week for 4 weeks.

Before and after the training, the study team measured how far each person could walk in 6 minutes, how long it took to stand up and walk a short distance and sit down again, how strong the knee muscles were, and how each person rated their own health and well-being. The study compared how much the two groups improved.

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
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 30 to 80 years
  • •Unilateral lower-limb weakness attributable to a stroke sustained within the previous year
  • •Able to complete the Timed Up and Go (TUG) test at baseline
  • •Able to follow training instructions
  • •Provided written informed consent

排除标准

  • •Baseline Timed Up and Go (TUG) time of less than 20 seconds
  • •Significant pain in the lower limbs
  • •Prior lower-limb surgery
  • •Neuromuscular disease affecting gait
  • •Cardiopulmonary condition contraindicating gait training
  • •Cognitive or cooperative deficits preventing the participant from following training instructions
  • •Inability to perform the Timed Up and Go (TUG) test at baseline

研究组 & 干预措施

Conventional

Active Comparator

干预措施: Conventional exoskeleton gait training (Device)

BCI-Controlled

Experimental

干预措施: BCI-controlled exoskeleton gait training (Device)

结局指标

主要结局

Change in 6-Minute Walk Test (6MWT) distance

时间窗: Baseline and 4 weeks (immediately before and after the 4-week training program)

Distance walked in 6 minutes along a flat 30-meter indoor corridor, recorded in meters. Participants were instructed to cover as much distance as possible. The same corridor was used for all assessments at both time points. Greater distance indicates better walking capacity.

次要结局

  • Change in SF-12 Physical Component Summary (PCS) score(Baseline and 4 weeks (immediately before and after the 4-week training program))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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