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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03048968
Collaborator
Samsung Electronics (Industry)
40
Enrollment
1
Location
2
Arms
7.8
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Gait, sit-to-stand movement, stair climbing and treadmill gait
  • Procedure: Sit-to-stand movement and treadmill gait
  • Device: gait enhancing mechatronic system (GEMS)
  • Device: treadmill
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Sep 30, 2017
Actual Study Completion Date :
Oct 23, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: study group1: elderly adults

Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS

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

Device: gait enhancing mechatronic system (GEMS)
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.

Device: treadmill
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Experimental: study group2: stroke patients

Sit-to-stand movement and treadmill gait with GEMS and without GEMS

Procedure: Sit-to-stand movement and treadmill gait
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.

Device: gait enhancing mechatronic system (GEMS)
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.

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

Outcome Measures

Primary Outcome Measures

  1. Cortical activation [30minutes]

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

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. Range of Motion (ROM) [20minutes]

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

  5. 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.

  6. 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.

  7. 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."

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 84 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Elderly adults

  1. Age: between 65 and 84 years

  2. elderly adults who had no neurological or musculoskeletal abnormalities affecting gait

  3. Ability to walk at least 10m regardless of assist devices

  • Stroke

  1. Age: between 20 and 84 years

  2. ≥ 3 months post stroke

  3. Ability to walk at least 10m regardless of assist devices

  4. Adequate gait function (FAC > 3)

  5. Physician approval for patient participation

Exclusion Criteria:
  • Elderly adults

  1. History of any diseases (eg. lower extremity orthopedic diseases, neurologic disorders, cardiovascular disease, heart failure, uncontrolled hypertension that affect walking capacity, efficiency, and endurance)

  2. Severe visual impairment or dizziness that increases the risk of falls

  • Stroke

  1. 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)

  2. Advanced liver, kidney, cardiac, or pulmonary disease

  3. History of concussion in last 6 months

  4. History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits

  5. Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of

Sponsors and Collaborators

  • Samsung Medical Center
  • Samsung Electronics

Investigators

  • Study Chair: Yun-Hee Kim, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yun-Hee Kim, Professor, MD, PhD, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT03048968
Other Study ID Numbers:
  • 2016-07-093
First Posted:
Feb 9, 2017
Last Update Posted:
Apr 29, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yun-Hee Kim, Professor, MD, PhD, Samsung Medical Center
Exoskeleton Device
elderly
stroke
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Apr 29, 2019