The Effect of Exercise With Wearable Walking Assist Robot in Various Environments in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline performance on gait speed after the intervention
研究概览
简要总结
This single-blinded, randomized, controlled trial includes 60 healthy adults. The participants were randomized to four different groups. The first group performed over-ground walking without GEMS-H, the second group performed over-ground walking with GEMS-H applied resistance mode, the third group performed stair ascent with GEMS-H applied assist mode, and the fourth group were designated as the group that performed inclined gait with GEMS-H applied assist mode on a treadmill. Each group is divided in 15 participants.
详细描述
At the first visit, the subjects are fully informed of the study if appropriate after determining whether they meet the selection criteria. If the subjects meet the selection criteria, the participants were randomized to four different groups. The first group performed over-ground walking without GEMS-H, the second group performed over-ground walking with GEMS-H with resistance mode, the third group performed stair ascent with GEMS-H with assist mode, and the fourth group were designated as the group that performed inclined gait with GEMS-H with assist mode on a treadmill. Each group is divided in 15 participants. Each group completed 30 minutes exercise at least three times per week (total 10 sessions). All measurements were conducted before and after the intervention.
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
- Single (Investigator)
盲法说明
Single masking (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 50 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 with severe arthritis or orthopedic problems limiting passive range of motion (ROM) of the lower extremities (knee flexion contracture >10°, knee flexion ROM <90°, hip flexion contracture >25°, ankle plantar flexion contracture >15°)
- •Those who have difficulty understanding the exercise program due to severe cognitive decline (Korean-Mini-Mental State Examination, K-MMSE≤10)
- •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
结局指标
主要结局
Change from baseline performance on gait speed after the intervention
时间窗: Baseline, After the intervention(day12)
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
- Change from baseline performance on Short Physical Performance Battery (SPPB) after the intervention(Baseline, After the intervention(day12))
- Change from baseline performance on muscle strength after the intervention(Baseline, After the intervention(day12))
- Change from baseline performance on Timed Up and Go test (TUG) after the intervention(Baseline, After the intervention(day12))
- Change from baseline performance on EuroQol 5 Dimensions (EQ-5D) after the intervention(Baseline, After the intervention(day12))
- Change from baseline performance on Berg Balance Scale (BBS) after the intervention(Baseline, After the intervention(day12))
- Change from baseline performance on Geriatric Depression Scale (GDS) after the intervention(Baseline, After the intervention(day12))
- Change from baseline performance on metabolic energy expenditure after the intervention(Baseline, After the intervention(day12))
- Change from baseline performance on Functional Reach Test (FRT) after the intervention(Baseline, After the intervention(day12))
- Change from baseline performance on Four Square Step Test (FSST) after the intervention(Baseline, After the intervention(day12))
- Change from baseline performance on Fall Efficacy Scale-Korea (FES-K) after the intervention(Baseline, After the intervention(day12))
研究者
Yun-Hee Kim
Dr., Ph.D.
Samsung Medical Center