Usability and Satisfaction Test to the Wearable Walking-assist Robot (GEMS-H) in the Community-dwelling Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Change in 10 meter walk test from baseline in gait speed
研究概览
简要总结
The purpose of this study is to investigate the userbility and satisfaction of one-off functional gait training with the Gait Enhancing and Motivating System-Hip type (GEMS-H) on locomotor function in normal adults including the elderly.
详细描述
The GEMS-H is a hip-type assist device developed by the Samsung Advanced Institute of Technology. The GEMS-H is worn around the waist and fastened at the waist and thighs by a set of belts with velcro to assist motion at the hip joints. The device weighs 2.1kg, and has 2 brushless direct current motors running on a rechargeable lithium ion battery. The normal operation time for the device is 2 hours. The GEMS-H is available in three sizes to fit various waist/hip sizes: small, medium, and large. The width of each version can be adjusted further to fit individual body size within the circumference range. Also, the thigh frames are available in three sizes (large, medium, and small) for different leg lengths. It is controlled through a custom built application on a hand held tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 40 to less than 85 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 have difficulty understanding the exercise program due to severe cognitive decline (Korean-Mini-Mental State Examination, K-MMSE≤10)
- •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
Training with Gait Enhancing and Motivating System (GEMS-H) Robot
Training consists of 15 minutes task-specific training and 20-30 minutes functional gait training on varied environments with device.
干预措施: Training with Gait Enhancing and Motivating System (GEMS-H) Robot (Device)
结局指标
主要结局
Change in 10 meter walk test from baseline in gait speed
时间窗: Baseline, After 45minutes of functional gait training (one-time experience)
Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."
次要结局
- Changes in Four Square Step Test (FSST) from baseline(Baseline, After 45minutes of functional gait training (one-time experience))
- Change in Timed Up and Go test (TUG) from baseline in balance(Baseline, After 45minutes of functional gait training (one-time experience))
- User Satisfaction Questionnaire(After 45minutes of functional gait training (one-time experience))
- Changes in Short Physical Performance Battery (SPPB) from baseline(Baseline, After 45minutes of functional gait training (one-time experience))
- Change in 6 minute walk test (6MWT) from Baseline(Baseline, After 45minutes of functional gait training (one-time experience))
研究者
Yun-Hee Kim
Principal Investigator
Samsung Medical Center