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临床试验/NCT05862077
NCT05862077已完成不适用

Long-term Exercise Effect of EX1 Exercise Program

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2023年3月28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
45
试验地点
2
主要终点
Change on gait function (muscle activation)

研究概览

简要总结

The purpose of this study was to investigate the effect of a long-term exercise program using a wearable exoskeleton robot (EX1) on muscular strength in healthy adults aged 19 to under 65 years, compared to an exercise program without EX1.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults aged 19 to less than 65 years without a history of central nervous system disease

排除标准

  • Those who have difficulty walking independently due to problems such as visual field defects or fractures
  • Those who have difficulty participating in exercise programs due to adult diseases such as uncontrolled hypertension and diabetes
  • Those who are at risk of falling while walking due to severe dizziness
  • Those who are less than 140 cm or more than 185 cm in height that is not suitable size for the wearing of the walking assistance robot
  • Those who are overweight based on body mass index (BMI) 35 or higher

研究组 & 干预措施

Overground walking exercise without EX1

Sham Comparator

Exercise consists of 30 minutes of overground walking.

干预措施: Without Wearable Hip Assist Robot(EX1) (Device)

Exercise program 1 with EX1

Experimental

Exercise program 1 consists of 30 minutes of overground walking.

干预措施: Wearable Hip Assist Robot(EX1) (Device)

Exercise program 1 with EX1

Experimental

Exercise program 1 consists of 30 minutes of overground walking.

干预措施: Exercise Program 1 (Behavioral)

Exercise program 2 with EX1

Experimental

Exercise program 2 consists of 30 minutes of overground walking.

干预措施: Wearable Hip Assist Robot(EX1) (Device)

Exercise program 2 with EX1

Experimental

Exercise program 2 consists of 30 minutes of overground walking.

干预措施: Exercise Program 2 (Behavioral)

结局指标

主要结局

Change on gait function (muscle activation)

时间窗: Session 0 (initial visit); after session 18 (at approximately 6 weeks)

All subjects perform overground walking to assess the change of muscle activation after the interventions using a surface EMG (6 channels).

次要结局

  • User Satisfaction Questionnaire(After session 18 (at approximately 6 weeks))
  • Change in heart rate(Every session (total 18 sessions/ 30 minutes))
  • Reduction in body fat percentage(Session 0 (initial visit); after session 18 (at approximately 6 weeks))
  • Change on gait function (kinematic)(Session 0 (initial visit); after session 18 (at approximately 6 weeks))
  • Reduction in stress level(Session 0 (initial visit); after session 18 (at approximately 6 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yun-Hee Kim

Dr., Ph.D.

Samsung Medical Center

研究点 (2)

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