The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults
- Conditions
- HealthyStroke
- Interventions
- Procedure: Gait, sit-to-stand movement, stair climbing and treadmill gaitProcedure: Sit-to-stand movement and treadmill gaitDevice: gait enhancing mechatronic system (GEMS)Device: treadmill
- Registration Number
- NCT03048968
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
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.
- Detailed Description
In elderly adults,
1. 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.
2. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.
3. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during stair climbing.
4. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
In stroke patients,
1. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.
2. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
-
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
-
Stroke
- 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
-
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
-
Stroke
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description study group1: elderly adults gait enhancing mechatronic system (GEMS) Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS study group1: elderly adults Gait, sit-to-stand movement, stair climbing and treadmill gait Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS study group1: elderly adults treadmill Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS study group2: stroke patients treadmill Sit-to-stand movement and treadmill gait with GEMS and without GEMS study group2: stroke patients Sit-to-stand movement and treadmill gait Sit-to-stand movement and treadmill gait with GEMS and without GEMS study group2: stroke patients gait enhancing mechatronic system (GEMS) Sit-to-stand movement and treadmill gait with GEMS and without GEMS
- Primary Outcome Measures
Name Time Method Cortical activation 30minutes Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
- Secondary Outcome Measures
Name Time Method Berg Balance Scale (BBS) 30minutes The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed.
Fall Efficacy Scale (FES) 20minutes Fall Efficacy Scale (FES) is a 10-item questionnaire designed confidence in their ability to perform 10 daily tasks without falling as an indicator of how one's fear of falling impacts physical performance. Each item is rated from 1 ("very confident") to 10 ("not confident at all"), and the per item ratings are added to generate a summary total score.
Manual Muscle Test (MMT) 20minutes Manual muscle testing (MMT) is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance.
Range of Motion (ROM) 20minutes Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.
Change in 10 meter walk test from baseline in gait speed 1hour 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."
Functional Ambulation Classification (FAC) 20minutes The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.
The modified Rankin Scale (mRS) 20minutes The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of