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Clinical Trials/NCT03708016
NCT03708016CompletedNot Applicable

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

Samsung Medical Center2 sites in 1 country30 target enrollmentStarted: October 18, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Change in 10 meter walk test from baseline in gait speed
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in 10 meter walk test from baseline in gait speed

Time Frame: 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 Outcomes

  • 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))
  • Change on gait function (muslce activation)(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))
  • 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))
  • 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))
  • Change on gait function (kinematic)(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(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))
  • Change on gait function (kinetic)(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))
  • Changes in motor evoked potentia(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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Effect of Robot Gait Training With Brain... | Clinical Trial