Clinical trial NCT03708016: Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients
Official title: Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in 10 meter walk test from baseline in gait speed
timeFrame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Secondary outcomes:
measure: Change in Berg Balance Scale from baseline in balance
timeFrame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
measure: Change in Functional ambulatory category from baseline in gait function
timeFrame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
measure: Change in Timed Up and Go test from baseline in balance
timeFrame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
measure: Change on gait function (kinematic)
timeFrame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
measure: Change on gait function (kinetic)
timeFrame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
measure: Change on gait function (muslce activation)
timeFrame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
measure: Changes in motor evoked potentia
timeFrame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
measure: Changes in Brain activation of resting-state functional MRI
timeFrame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
Study officials:
References: