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Completed

NCT Number: NCT03048968

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Healthy Nervous System Diseases Vascular Diseases

Age range

20 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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
  • 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

Treatment and study plan

Gait, sit-to-stand movement, stair climbing and treadmill gait

Procedure

Spatio temporal characteristics, muscle activation and foot pressure distribution are measured by motion capture system, surface electromyography (sEMG) and F-Scan Mobile system 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.

Sit-to-stand movement and treadmill gait

Procedure

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.

gait enhancing mechatronic system (GEMS)

Device

Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS in elderly adults.

Sit-to-stand movement and treadmill gait with GEMS and without GEMS in stroke patients.

Treadmill

Device

Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

Primary outcomes

  1. Cortical activation

    Time frame: 30minutes

    Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

Secondary outcomes

  1. Berg Balance Scale (BBS)

    Time frame: 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.

  2. Fall Efficacy Scale (FES)

    Time frame: 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.

  3. Manual Muscle Test (MMT)

    Time frame: 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.

  4. Range of Motion (ROM)

    Time frame: 20minutes

    Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.

  5. Functional Ambulation Classification (FAC)

    Time frame: 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.

  6. The modified Rankin Scale (mRS)

    Time frame: 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.

  7. Change in 10 meter walk test from baseline in gait speed

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Samsung Electronics

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2017
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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