NCT03708016

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

October 18, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

May 27, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

October 12, 2018

Last Update Submit

May 25, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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)

  • 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 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 (kinematic)

    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)

  • +3 more secondary outcomes

Study Arms (2)

Robot gait training with brain stimulation

EXPERIMENTAL

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

Device: Robot gait trainingDevice: Brain stimulation

Robot gait training without brain stimulation

ACTIVE COMPARATOR

Lokomat robot training and sham tDCS on the leg motor areas

Device: Robot gait training

Interventions

Robot gait trainingDEVICE

Lokomat robot training was applied to stroke patients.

Robot gait training with brain stimulationRobot gait training without brain stimulation
Brain stimulationDEVICE

tDCS brain stimulation on leg motor areas was applied to stroke patients.

Robot gait training with brain stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: more than 18 years
  • More than 6 months post stroke
  • Functional ambulation classification (FAC) (1\~4)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 16, 2018

Study Start

October 18, 2018

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

May 27, 2020

Record last verified: 2020-03

Locations

KR(1)