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

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ClinicalTrials.gov Identifier: NCT03708016
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Brief Summary:
The purpose of this study was to investigate the effects of robot gait training with the noninvasive brain stimulation in stroke patients.

Condition or disease Intervention/treatment Phase
Stroke Device: Robot gait training Device: Brain stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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."



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708016


Contacts
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Contact: Yun-Hee Kim, MD, PhD +82-2-3410-2818 yun1225.kim@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Gangnam-gu, Korea, Republic of, 06351
Contact: Yun-Hee Kim, MD, PhD    82-2-3410-2824    yun1225.kim@samsung.com   
Contact: Ahee Lee, MS    82-2-3410-2818    ahee.lee@gmail.com   
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03708016     History of Changes
Other Study ID Numbers: 2018-05-015
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases