Effect of GEMS-H on Locomotor Function in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in 10 Meter Walk Test-Self Selected Velocity (sec) from Baseline to Post-Training Assessment
研究概览
简要总结
The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor function. Specifically, individuals in the GEMS-H group will show faster gait speed compared to those in the control group.
详细描述
The GEMS-H is a hip-type assist device developed by Samsung Electronics. 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. It is controlled through a custom built application on a hand held tablet.
The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor function. Specifically, individuals in the GEMS-H group will show faster gait speed compared to those in the control group.
Participants will be scheduled for 18 sessions of training (randomly placed either in GEMS-H training group or traditional training group without the GEM-H) plus 5 sessions of testing (pre-training, mid-test after the 9 sessions of training, post-training, 1 month follow-up and 3 month follow-up after the 18 sessions training completed).
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
- Single (Outcomes Assessor)
盲法说明
A blinded research physical therapist will test the outcome measure at baseline, mid testing after 9th session of training, at post testing after 18th session of training, at 1 month follow up testing after 18th session of training and at 3 months follow up testing after 18th session of training.
入排标准
- 年龄范围
- 19 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 19 - 84 years
- •No history of central nervous system related disease
排除标准
- •Difficulty in walking due to conditions such as poor vision or fractures
- •Height is less than 140cm or more than 185cm.
- •Body mass index (BMI) greater than
- •Difficulty understanding and participating in the study such as those with cognitive problems or dementia.
- •Subject who is at risk of falling during walking due to severe dizziness
研究组 & 干预措施
Training with GEMS-H
Participants will participate in 18 sessions of training + 5 sessions of testing for up to 3 month.
Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with the device.
干预措施: with Gait Enhancing and Motivating System-Hip (GEMS-H) (Device)
Training without GEMS-H
Participants will participate in 18 sessions of training + 5 sessions of testing for up to 3 month.
Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments without the device.
干预措施: without Gait Enhancing and Motivating System-Hip (GEMS-H) (Other)
结局指标
主要结局
Change in 10 Meter Walk Test-Self Selected Velocity (sec) from Baseline to Post-Training Assessment
时间窗: Baseline Assessment, Post Training Assessment (6 weeks)
Measure of self-selected walking speeds by measuring the time it takes a participant to walk 10 meters. The test is performed using a "flying start," the participant 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
- Functional Reach Test (FRT)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Four Square Step Test (FSST)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Timed Up and Go test (TUG)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Change in 10 Meter Walk Test-Fast Velocity (sec) from Baseline(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Wearable activity tracker (Measurement: Step count, Calorie consumption, and Heart rate)(Up to Post Training Assessment (Up to 6 weeks))
- Change in Muscle Strength from Baseline(Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Change in 10 Meter Walk Test-Self Selected Velocity (sec) from Baseline to Other Assessment Time Points(Baseline Assessment, Mid Training Assessment (3 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Short Physical Performance Battery (SPPB)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- EuroQol 5 Dimensions (EQ-5D)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)])
- Visual Analogue Scale (VAS)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Change in Muscle Activation Pattern and Effort (%MVC) during Gait from Baseline(Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Berg Balance Scale (BBS)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Functional Gait Assessment (FGA)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Five times Sit to Stand (5xSST)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Korean-Modified Barthel Index (K-MBI)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Fall Efficacy Scale-Korean (FES-K)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Geriatric Depression Scale-a short version (GDS-SF)(Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Change in Gait Function from Baseline(Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))
- Change in Cardiopulmonary Metabolic Energy Consumption from Baseline(Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up))