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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Robot gait training; Device: Brain stimulation

• Registration Number: NCT03708016
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-16
• Study Start: 2018-10-18
• Status Verified: 2020-03
• Primary Completion: 2020-03-17
• Study Completion: 2020-03-17
• Last Update Submitted: 2020-05-25
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot gait training without brain stimulation	Robot gait training	Lokomat robot training and sham tDCS on the leg motor areas
Robot gait training with brain stimulation	Brain stimulation	Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas
Robot gait training with brain stimulation	Robot gait training	Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas

Primary Outcome Measures

Name	Time	Method
Change in 10 meter walk test from baseline in gait speed	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."

Secondary Outcome Measures

Name	Time	Method
Change in Functional ambulatory category from baseline in gait function	session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)	Measure of functional ambulatory category
Change on gait function (muslce activation)	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.
Change in Berg Balance Scale from baseline in balance	session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)	Meserue of blance function
Changes in Brain activation of resting-state functional MRI	session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)	Neuroplasticity measure
Change on gait function (kinematic)	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.
Change in Timed Up and Go test from baseline in balance	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
Change on gait function (kinetic)	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
Changes in motor evoked potentia	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of