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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708016
• Other study ID #: 2018-05-015
• Status: Completed
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: March 17, 2020

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Robot gait training
Lokomat robot training was applied to stroke patients.
• Brain stimulation
tDCS brain stimulation on leg motor areas was applied to stroke patients.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)