The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Cortical activation
Study Overview
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,
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
study group2: stroke patients
Sit-to-stand movement and treadmill gait with GEMS and without GEMS
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: treadmill (Device)
study group2: stroke patients
Sit-to-stand movement and treadmill gait with GEMS and without GEMS
Intervention: gait enhancing mechatronic system (GEMS) (Device)
study group2: stroke patients
Sit-to-stand movement and treadmill gait with GEMS and without GEMS
Intervention: treadmill (Device)
Outcomes
Primary Outcomes
Cortical activation
Time Frame: 30minutes
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Secondary Outcomes
- 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)
Investigators
Yun-Hee Kim
Professor, MD, PhD
Samsung Medical Center