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

Primary Purpose

Stroke, Healthy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gait, sit-to-stand movement, stair climbing and treadmill gait
Sit-to-stand movement and treadmill gait
gait enhancing mechatronic system (GEMS)
treadmill
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Exoskeleton Device, elderly, stroke

Eligibility Criteria

20 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group1: elderly adults

study group2: stroke patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Berg Balance Scale (BBS)
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)
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)
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)
Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.
Functional Ambulation Classification (FAC)
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)
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.
Change in 10 meter walk test from baseline in gait speed
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."

Full Information

First Posted
February 6, 2017
Last Updated
April 25, 2019
Sponsor
Samsung Medical Center
Collaborators
Samsung Electronics
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1. Study Identification

Unique Protocol Identification Number
NCT03048968
Brief Title
The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults
Official Title
The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
October 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Samsung Electronics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Healthy
Keywords
Exoskeleton Device, elderly, stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group1: elderly adults
Arm Type
Experimental
Arm Description
Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS
Arm Title
study group2: stroke patients
Arm Type
Experimental
Arm Description
Sit-to-stand movement and treadmill gait with GEMS and without GEMS
Intervention Type
Procedure
Intervention Name(s)
Gait, sit-to-stand movement, stair climbing and treadmill gait
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sit-to-stand movement and treadmill gait
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
gait enhancing mechatronic system (GEMS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
treadmill
Intervention Description
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Primary Outcome Measure Information:
Title
Cortical activation
Description
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Time Frame
30minutes
Secondary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
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.
Time Frame
30minutes
Title
Fall Efficacy Scale (FES)
Description
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.
Time Frame
20minutes
Title
Manual Muscle Test (MMT)
Description
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.
Time Frame
20minutes
Title
Range of Motion (ROM)
Description
Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.
Time Frame
20minutes
Title
Functional Ambulation Classification (FAC)
Description
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.
Time Frame
20minutes
Title
The modified Rankin Scale (mRS)
Description
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.
Time Frame
20minutes
Title
Change in 10 meter walk test from baseline in gait speed
Description
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."
Time Frame
1hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Hee Kim
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33121535
Citation
Lee SH, Lee HJ, Shim Y, Chang WH, Choi BO, Ryu GH, Kim YH. Wearable hip-assist robot modulates cortical activation during gait in stroke patients: a functional near-infrared spectroscopy study. J Neuroeng Rehabil. 2020 Oct 29;17(1):145. doi: 10.1186/s12984-020-00777-0.
Results Reference
derived

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

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