Gait Pattern Analysis and Feasibility of Gait Training With a Newly Developed Walking Assist Robot in Stroke Patients and Elderly Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 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 was to investigate the effects of the new wearable hip assist robot developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) to gait rehabilitation in elderly adults and stroke patients.
详细描述
Randomized, two treatment groups
Number of Subjects : 54 subjects (n=27 per group)
Group 1 : gait rehabilitation with hip assist robot / 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30min per session
Group 2 : gait rehabilitation without hip assist robot / 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30min per session
Primary objective is to demonstrate the effects of hip assist robot on spatio-temporal parameters measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), muscle activation patterns measured by surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA), metabolic energy cost parameters measured by portable cardiopulmonary metabolic system (Cosmed K4B2, Rome, Italy) and foot pressure distribution measured by F-Scan Mobile system (Tekscan Inc., South Boston, MA, USA).
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
- 50 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly adults
- •Age: between 65 and 84 years
- •elderly adults who had no neurological or musculoskeletal abnormalities affecting gait
- •Ability to walk at least 10m regardless of assist devices
- •High levels of physical performance (SPPB > 7)
- •Subject is willing to be randomized to the control group or the treatment group
- •Age: between 50 and 84 years
- •≥ 3 months post stroke
- •Ability to walk at least 10m regardless of assist devices
- •Adequate gait function (FAC > 3)
- •Physician approval for patient participation
- •Subject is willing to be randomized to the control group or the treatment group
排除标准
- •Elderly adults
- •History of any diseases (eg. lower extremity orthopedic diseases, neurologic disorders, cardiovascular disease, heart failure, uncontrolled hypertension that affect walking capacity, efficiency, and endurance)
- •Severe visual impairment or dizziness that increases the risk of falls
- •Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
- •Advanced liver, kidney, cardiac, or pulmonary disease
- •History of concussion in last 6 months
- •History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
- •Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia
研究组 & 干预措施
Samsung Hip Assist v1
gait rehabilitation with Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session
干预措施: gait rehabilitation with Samsung Hip Assist v1 (Device)
Conventional gait training
gait rehabilitation without Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session
干预措施: gait rehabilitation without Samsung Hip Assist v1 (Other)
结局指标
主要结局
Change in 10 meter walk test from baseline in gait speed
时间窗: session 0 (initial visit); session 11 (at approximately 4 weeks)
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
- Modified Bathel index (MBI)(session 0 (initial visit); session 11 (at approximately 4 weeks))
- Tinetti performance oriented mobility assessment (POMA)(session 0 (initial visit); session 11 (at approximately 4 weeks))
- Berg Balance Scale (BBS)(session 0 (initial visit); session 11 (at approximately 4 weeks))
- Modified Rankin Scale (MRS)(session 0 (initial visit); session 11 (at approximately 4 weeks))
- Functional Ambulation Classification (FAC)(session 0 (initial visit); session 11 (at approximately 4 weeks))
- Fugl-Meyer assessment for lower extremity (FMA)(session 0 (initial visit); session 11 (at approximately 4 weeks))
- Fall Efficacy Scale (FES)(session 0 (initial visit); session 11 (at approximately 4 weeks))
- Manual Muscle Test (MMT)(session 0 (initial visit); session 11 (at approximately 4 weeks))
- Range of Motion (ROM)(session 0 (initial visit); session 11 (at approximately 4 weeks))
研究者
Yun-Hee Kim
Professor, MD, PhD
Samsung Medical Center