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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot gait training
Brain stimulation
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot gait training with brain stimulation

Robot gait training without brain stimulation

Arm Description

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

Lokomat robot training and sham tDCS on the leg motor areas

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

Change in Berg Balance Scale from baseline in balance
Meserue of blance function
Change in Functional ambulatory category from baseline in gait function
Measure of functional ambulatory category
Change in Timed Up and Go test from baseline in balance
Measure of Timued Up and Go test in balance
Change on gait function (kinematic)
All participants perform overground walking to assess the change of kinematic using a motion analysis.
Change on gait function (kinetic)
All participants perform overground walking to assess the change of kinetic using a force plate
Change on gait function (muslce activation)
All participants perform overground walking to assess the change of muscle activation using a surface EMG.
Changes in motor evoked potentia
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.
Changes in Brain activation of resting-state functional MRI
Neuroplasticity measure

Full Information

First Posted
October 12, 2018
Last Updated
May 25, 2020
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03708016
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot gait training with brain stimulation
Arm Type
Experimental
Arm Description
Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas
Arm Title
Robot gait training without brain stimulation
Arm Type
Active Comparator
Arm Description
Lokomat robot training and sham tDCS on the leg motor areas
Intervention Type
Device
Intervention Name(s)
Robot gait training
Intervention Description
Lokomat robot training was applied to stroke patients.
Intervention Type
Device
Intervention Name(s)
Brain stimulation
Intervention Description
tDCS brain stimulation on leg motor areas was applied to stroke patients.
Primary Outcome Measure Information:
Title
Change in 10 meter walk test from baseline in gait speed
Description
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."
Time Frame
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Secondary Outcome Measure Information:
Title
Change in Berg Balance Scale from baseline in balance
Description
Meserue of blance function
Time Frame
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Title
Change in Functional ambulatory category from baseline in gait function
Description
Measure of functional ambulatory category
Time Frame
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Title
Change in Timed Up and Go test from baseline in balance
Description
Measure of Timued Up and Go test in balance
Time Frame
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Title
Change on gait function (kinematic)
Description
All participants perform overground walking to assess the change of kinematic using a motion analysis.
Time Frame
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Title
Change on gait function (kinetic)
Description
All participants perform overground walking to assess the change of kinetic using a force plate
Time Frame
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Title
Change on gait function (muslce activation)
Description
All participants perform overground walking to assess the change of muscle activation using a surface EMG.
Time Frame
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Title
Changes in motor evoked potentia
Description
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.
Time Frame
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Title
Changes in Brain activation of resting-state functional MRI
Description
Neuroplasticity measure
Time Frame
session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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