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Clinical Trials/NCT03048968
NCT03048968
Completed
N/A

The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults

Samsung Medical Center1 site in 1 country40 target enrollmentMarch 1, 2017
ConditionsStrokeHealthy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Samsung Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Cortical activation
Status
Completed
Last Updated
7 years ago

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, 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
October 23, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yun-Hee Kim

Professor, MD, PhD

Samsung Medical Center

Eligibility Criteria

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

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)

Study Sites (1)

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