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

Samsung Medical Center

Status: Completed

Conditions: Stroke

Treatments: Device: Robot gait training; Device: Brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03708016

2018-05-015

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Robot gait training with brain stimulation

Experimental group

Description:

Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas

Treatment:

Device: Robot gait training

Device: Brain stimulation

Robot gait training without brain stimulation

Active Comparator group

Description:

Lokomat robot training and sham tDCS on the leg motor areas

Treatment:

Device: Robot gait training