Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke

December 18, 2016 updated by: Byung-Mo Oh, Seoul National University Hospital

Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke: A Double-blind, Randomized, Controlled Trial

  1. Study objective To evaluate the effect of robotic-assisted gait training combined with transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted gait training on gait function of chronic stroke patients
  2. Subjects chronic stroke patients with gait impairment

  3. Methods

    • Group 1: Robotic-assisted gait training with anodal tDCS (45 min)
    • Group 2: Robotic-assisted gait training with sham tDCS (45 min)
    • Duration of treatment: 2 weeks, 5 times a week
    • Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment

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.
21

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
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stroke patients who diagnosed by computed tomography or magnetic resonance imaging
  • Hemiplegic patients due to unilateral lesion
  • Patients in chronic stage after 6 months from stroke onset
  • Patients with gait impairment (FAC <= 4)
  • Adult (Age >= 18)

Exclusion Criteria:

  • Unstable vital sign
  • History of seizure or cranial operation
  • unable to walk before stroke
  • bilateral hemispheric lesions
  • metalic implant (cardiac pacemaker, artificial cochlear, etc.)
  • severe cognitive deficit, MMSE < 10
  • severe aphasic patient who cannot communicate at all

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 + anodal tDCS
Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min
Device: tDCS
tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere before robotic-assisted gait training. Anodal tDCS will be applied with an intensity of 2mA for 20 min. Sham tDCS will be applied with an intensity of 2mA just for 1 min, after which the current will be slowly tapered down to 0 over a several seconds.
Other Names:
  • DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)
Device: Robotic-assisted gait training
Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments
Other Names:
  • Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea)
Sham Comparator: Robot + sham tDCS
Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min
Device: tDCS
tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere before robotic-assisted gait training. Anodal tDCS will be applied with an intensity of 2mA for 20 min. Sham tDCS will be applied with an intensity of 2mA just for 1 min, after which the current will be slowly tapered down to 0 over a several seconds.
Other Names:
  • DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)
Device: Robotic-assisted gait training
Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments
Other Names:
  • Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea)

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
Functional Ambulatory Category (FAC)
Time Frame: Baseline
Assesses functional ambulation in patients undergoing physical therapy
Baseline
Functional Ambulatory Category (FAC)
Time Frame: 1 day after treatment
Assesses functional ambulation in patients undergoing physical therapy
1 day after treatment
Functional Ambulatory Category (FAC)
Time Frame: 4 weeks after treatment
Assesses functional ambulation in patients undergoing physical therapy
4 weeks after treatment

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
10-meter walk test
Time Frame: Baseline
Time for walking 10 meters
Baseline
10-meter walk test
Time Frame: 1 day after treatment
Time for walking 10 meters
1 day after treatment
10-meter walk test
Time Frame: 4 weeks after treatment
Time for walking 10 meters
4 weeks after treatment
6-min walk test
Time Frame: Baseline
Walking distance for 6 min
Baseline
6-min walk test
Time Frame: 1 day after treatment
Walking distance for 6 min
1 day after treatment
6-min walk test
Time Frame: 4 weeks after treatment
Walking distance for 6 min
4 weeks after treatment
Modified Rankin's Scale
Time Frame: Baseline
Baseline
Modified Rankin's Scale
Time Frame: 1 day after treatment
1 day after treatment
Modified Rankin's Scale
Time Frame: 4 weeks after treatment
4 weeks after treatment
Fugl-Meyer assessment scale for lower extremity
Time Frame: Baseline
Assess the function of lower extremity in stroke patients
Baseline
Fugl-Meyer assessment scale for lower extremity
Time Frame: 1 day after treatment
Assess the function of lower extremity in stroke patients
1 day after treatment
Fugl-Meyer assessment scale for lower extremity
Time Frame: 4 weeks after treatment
Assess the function of lower extremity in stroke patients
4 weeks after treatment
Motor evoked potential
Time Frame: Baseline
Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation
Baseline
Motor evoked potential
Time Frame: 1 day after treatment
Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation
1 day after treatment

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.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Byung-Mo Oh, MD, PhD, Seoul National University Hospital

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

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.
September 1, 2013

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.
December 1, 2016

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).
September 15, 2013

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.
September 17, 2013

First Posted (Estimate)

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.
September 18, 2013

Study Record Updates

Last Update Posted (Estimate)

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.
December 20, 2016

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.
December 18, 2016

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.
December 1, 2016

More Information

Terms related to this study

Keywords

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.
  • Robot-tDCS-2013

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings