The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cortical activation
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, gait enhancing and motivating system (GEMS) developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) on gait, sit-to-stand movement and cortical activation in elderly adults and stroke patients.
详细描述
In elderly adults,
- Spatio temporal characteristics, muscle activation and foot pressure distribution are measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA) and F-Scan Mobile system (Tekscan Inc., South Boston, MA, USA) during 10m walking test.
- Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.
- Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during stair climbing.
- Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
In stroke patients,
- Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.
- Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 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
- •Age: between 20 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
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
study group2: stroke patients
Sit-to-stand movement and treadmill gait with GEMS and without GEMS
干预措施: Sit-to-stand movement and treadmill gait (Procedure)
study group1: elderly adults
Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS
干预措施: Gait, sit-to-stand movement, stair climbing and treadmill gait (Procedure)
study group1: elderly adults
Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS
干预措施: gait enhancing mechatronic system (GEMS) (Device)
study group1: elderly adults
Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS
干预措施: treadmill (Device)
study group2: stroke patients
Sit-to-stand movement and treadmill gait with GEMS and without GEMS
干预措施: gait enhancing mechatronic system (GEMS) (Device)
study group2: stroke patients
Sit-to-stand movement and treadmill gait with GEMS and without GEMS
干预措施: treadmill (Device)
结局指标
主要结局
Cortical activation
时间窗: 30minutes
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
次要结局
- Berg Balance Scale (BBS)(30minutes)
- Fall Efficacy Scale (FES)(20minutes)
- Manual Muscle Test (MMT)(20minutes)
- Range of Motion (ROM)(20minutes)
- Change in 10 meter walk test from baseline in gait speed(1hour)
- Functional Ambulation Classification (FAC)(20minutes)
- The modified Rankin Scale (mRS)(20minutes)
研究者
Yun-Hee Kim
Professor, MD, PhD
Samsung Medical Center