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

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ClinicalTrials.gov Identifier: NCT02843828
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Samsung Electronics
Information provided by (Responsible Party):
Yun-Hee Kim, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE July 14, 2016
First Posted Date  ICMJE July 26, 2016
Last Update Posted Date April 10, 2019
Actual Study Start Date  ICMJE January 2, 2016
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
Change in 10 meter walk test from baseline in gait speed [ Time Frame: session 0 (initial visit); session 11 (at approximately 4 weeks) ]
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."
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • Berg Balance Scale (BBS) [ Time Frame: session 0 (initial visit); session 11 (at approximately 4 weeks) ]
    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) [ Time Frame: session 0 (initial visit); session 11 (at approximately 4 weeks) ]
    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) [ Time Frame: session 0 (initial visit); session 11 (at approximately 4 weeks) ]
    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) [ Time Frame: session 0 (initial visit); session 11 (at approximately 4 weeks) ]
    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) [ Time Frame: session 0 (initial visit); session 11 (at approximately 4 weeks) ]
    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) [ Time Frame: session 0 (initial visit); session 11 (at approximately 4 weeks) ]
    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) [ Time Frame: session 0 (initial visit); session 11 (at approximately 4 weeks) ]
    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) [ Time Frame: session 0 (initial visit); session 11 (at approximately 4 weeks) ]
    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) [ Time Frame: session 0 (initial visit); session 11 (at approximately 4 weeks) ]
    Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gait Pattern Analysis and Feasibility of Gait Training With a Walking Assist Robot in Stroke Patients and Elderly Adults
Official Title  ICMJE Gait Pattern Analysis and Feasibility of Gait Training With a Newly Developed Walking Assist Robot in Stroke Patients and Elderly Adults
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Healthy
Intervention  ICMJE
  • Device: gait rehabilitation with Samsung Hip Assist v1
    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
  • Other: gait rehabilitation without Samsung Hip Assist v1
    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
Study Arms  ICMJE
  • Experimental: Samsung Hip Assist v1
    gait rehabilitation with Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session
    Intervention: Device: gait rehabilitation with Samsung Hip Assist v1
  • Active Comparator: Conventional gait training
    gait rehabilitation without Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session
    Intervention: Other: gait rehabilitation without Samsung Hip Assist v1
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2017)
56
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
54
Actual Study Completion Date  ICMJE September 1, 2017
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02843828
Other Study ID Numbers  ICMJE 2015-05-013-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Yun-Hee Kim, Samsung Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Samsung Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Samsung Electronics
Investigators  ICMJE
Study Chair: Yun-Hee Kim, MD, PhD Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP