Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients

May 25, 2020 updated by: Samsung Medical Center
The purpose of this study was to investigate the effects of robot gait training with the noninvasive brain stimulation in stroke patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06351
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: more than 18 years
  • More than 6 months post stroke
  • Functional ambulation classification (FAC) (1~4)

Exclusion Criteria:

  • 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)
  • Difficult to understand experimental tasks because of extremely severe cognitive impairment
  • History of disorders involving central nervous system
  • History of psychiatric disease
  • implanted objects that would contraindicate tDCS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robot gait training with brain stimulation
Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas
Device: Robot gait training
Lokomat robot training was applied to stroke patients.
Device: Brain stimulation
tDCS brain stimulation on leg motor areas was applied to stroke patients.
Active Comparator: Robot gait training without brain stimulation
Lokomat robot training and sham tDCS on the leg motor areas
Device: Robot gait training
Lokomat robot training was applied to stroke patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 10 meter walk test from baseline in gait speed
Time Frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
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."
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Berg Balance Scale from baseline in balance
Time Frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Meserue of blance function
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Change in Functional ambulatory category from baseline in gait function
Time Frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Measure of functional ambulatory category
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Change in Timed Up and Go test from baseline in balance
Time Frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Measure of Timued Up and Go test in balance
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Change on gait function (kinematic)
Time Frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
All participants perform overground walking to assess the change of kinematic using a motion analysis.
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Change on gait function (kinetic)
Time Frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
All participants perform overground walking to assess the change of kinetic using a force plate
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Change on gait function (muslce activation)
Time Frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
All participants perform overground walking to assess the change of muscle activation using a surface EMG.
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Changes in motor evoked potentia
Time Frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Changes in Brain activation of resting-state functional MRI
Time Frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Neuroplasticity measure
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-05-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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