Effect of Simultaneous Application of HD-tDCS and Robot-assisted Gait Training on Gait Function in Stroke Patients

NCT ID: NCT04985864

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-05-16

Brief Summary

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The purpose of this study was to investigate the effects of simultaneous application of transcranial direct current stimulation (tDCS) with robotic gait training in stroke patients with gait impairment.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Robot gait training with brain stimulation

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

Group Type EXPERIMENTAL

Brain stimulation

Intervention Type DEVICE

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

Treadmill gait training

Intervention Type DEVICE

Lokomat robot training was applied to stroke patients.

Gait training with sham brain stimulation

Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas

Group Type ACTIVE_COMPARATOR

Treadmill gait training

Intervention Type DEVICE

Lokomat robot training was applied to stroke patients.

Interventions

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Brain stimulation

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

Intervention Type DEVICE

Treadmill gait training

Lokomat robot training was applied to stroke patients.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: 19 - 79 years
* More than 3 months post stroke
* Functional ambulation classification (FAC) (1\~4)

Exclusion Criteria

* History of serious neurological disease other than stroke
* Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
* History of psychiatric disease
* Contraindicated to tDCS
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ybrain Inc.

INDUSTRY

Sponsor Role collaborator

Yun-Hee Kim

OTHER

Sponsor Role lead

Responsible Party

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Yun-Hee Kim

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2021-06-131

Identifier Type: -

Identifier Source: org_study_id

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