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Gait Pattern Analysis and Feasibility of Gait Training With a Walking Assist Robot in Stroke Patients and Elderly Adults

Primary Purpose

Stroke, Healthy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gait rehabilitation with Samsung Hip Assist v1
gait rehabilitation without Samsung Hip Assist v1
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Exoskeleton Device, elderly, stroke, gait rehabilitation

Eligibility Criteria

50 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
    4. High levels of physical performance (SPPB > 7)
    5. Subject is willing to be randomized to the control group or the treatment group

  • Stroke

    1. Age: between 50 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
    6. Subject is willing to be randomized to the control group or the treatment group

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

Active Comparator

Arm Label

Samsung Hip Assist v1

Conventional gait training

Arm Description

gait rehabilitation with Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session

gait rehabilitation without Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session

Outcomes

Primary Outcome Measures

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."

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.
Tinetti performance oriented mobility assessment (POMA)
Task-oriented outcome measure that assesses gait and balance ability is composed of a 9-item gait portion (POMA-G) and 7-item balance portion (POMA-B).
Modified Bathel index (MBI)
The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing.
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.
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.
Fugl-Meyer assessment for lower extremity (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
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.

Full Information

First Posted
July 14, 2016
Last Updated
April 8, 2019
Sponsor
Samsung Medical Center
Collaborators
Samsung Electronics
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1. Study Identification

Unique Protocol Identification Number
NCT02843828
Brief Title
Gait Pattern Analysis and Feasibility of Gait Training With a Walking Assist Robot in Stroke Patients and Elderly Adults
Official Title
Gait Pattern Analysis and Feasibility of Gait Training With a Newly Developed Walking Assist Robot in Stroke Patients and Elderly Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2016 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
September 1, 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 developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) to gait rehabilitation in elderly adults and stroke patients.
Detailed Description
Randomized, two treatment groups Number of Subjects : 54 subjects (n=27 per group) Group 1 : gait rehabilitation with hip assist robot / 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30min per session Group 2 : gait rehabilitation without hip assist robot / 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30min per session Primary objective is to demonstrate the effects of hip assist robot on spatio-temporal parameters measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), muscle activation patterns measured by surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA), metabolic energy cost parameters measured by portable cardiopulmonary metabolic system (Cosmed K4B2, Rome, Italy) and foot pressure distribution measured by F-Scan Mobile system (Tekscan Inc., South Boston, MA, USA). Secondary objective is to demonstrate the effects of hip assist robot on motor function improvement evaluated by Berg Balance Scale (BBS), Tinetti performance oriented mobility assessment (POMA), Korean version Modified Bathel index (K-MBI), Modified Rankin Scale (MRS), Functional Ambulation Classification (FAC), Fugl-Meyer assessment for lower extremity (FMA), Korean version Fall Efficacy Scale (K-FES), Manual Muscle Test (MMT) and Range of Motion (ROM).

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, gait rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Samsung Hip Assist v1
Arm Type
Experimental
Arm Description
gait rehabilitation with Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session
Arm Title
Conventional gait training
Arm Type
Active Comparator
Arm Description
gait rehabilitation without Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session
Intervention Type
Device
Intervention Name(s)
gait rehabilitation with Samsung Hip Assist v1
Intervention Description
Participants will participate in 10 sessions of gait rehabilitation with Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session
Intervention Type
Other
Intervention Name(s)
gait rehabilitation without Samsung Hip Assist v1
Intervention Description
Participants will participate in 10 sessions of gait rehabilitation without Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session
Primary Outcome Measure Information:
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
session 0 (initial visit); session 11 (at approximately 4 weeks)
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
session 0 (initial visit); session 11 (at approximately 4 weeks)
Title
Tinetti performance oriented mobility assessment (POMA)
Description
Task-oriented outcome measure that assesses gait and balance ability is composed of a 9-item gait portion (POMA-G) and 7-item balance portion (POMA-B).
Time Frame
session 0 (initial visit); session 11 (at approximately 4 weeks)
Title
Modified Bathel index (MBI)
Description
The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing.
Time Frame
session 0 (initial visit); session 11 (at approximately 4 weeks)
Title
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
session 0 (initial visit); session 11 (at approximately 4 weeks)
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
session 0 (initial visit); session 11 (at approximately 4 weeks)
Title
Fugl-Meyer assessment for lower extremity (FMA)
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
Time Frame
session 0 (initial visit); session 11 (at approximately 4 weeks)
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
session 0 (initial visit); session 11 (at approximately 4 weeks)
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
session 0 (initial visit); session 11 (at approximately 4 weeks)
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
session 0 (initial visit); session 11 (at approximately 4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 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 High levels of physical performance (SPPB > 7) Subject is willing to be randomized to the control group or the treatment group Stroke Age: between 50 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 Subject is willing to be randomized to the control group or the treatment group 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, MD, PhD
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
31623545
Citation
Lee HJ, Lee SH, Seo K, Lee M, Chang WH, Choi BO, Ryu GH, Kim YH. Training for Walking Efficiency With a Wearable Hip-Assist Robot in Patients With Stroke: A Pilot Randomized Controlled Trial. Stroke. 2019 Dec;50(12):3545-3552. doi: 10.1161/STROKEAHA.119.025950. Epub 2019 Oct 18.
Results Reference
derived
PubMed Identifier
29183379
Citation
Lee SH, Lee HJ, Chang WH, Choi BO, Lee J, Kim J, Ryu GH, Kim YH. Gait performance and foot pressure distribution during wearable robot-assisted gait in elderly adults. J Neuroeng Rehabil. 2017 Nov 28;14(1):123. doi: 10.1186/s12984-017-0333-z.
Results Reference
derived

Learn more about this trial

Gait Pattern Analysis and Feasibility of Gait Training With a Walking Assist Robot in Stroke Patients and Elderly Adults

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