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

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: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Robot gait training; Device: Brain stimulation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Berg Balance Scale from baseline in balance	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	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	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)	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)	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)	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	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	Neuroplasticity measure	session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): March 17, 2020
• Study Completion (Actual): March 17, 2020

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID 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