NCT04985864

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable stroke

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

July 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

July 19, 2021

Last Update Submit

February 21, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in 10 meter walk test

    Measurement of the time it takes a subject to walk 10m with self selected gait speed. 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 4 weeks); after 4 weeks from intervention termination (follow-up)

Secondary Outcomes (11)

  • Change in Berg Balance Scale (BBS)

    session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

  • Change in Timed Up and Go test (TUG)

    session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

  • Changes in Brain activation of resting-state functional MRI

    session 0 (initial visit); session 10 (at approximately 4 weeks)

  • Change in Geriatric Depression Scale (GDS)

    session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

  • Changes in motor evoked potential

    session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

  • +6 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: Brain stimulationDevice: Treadmill gait training

Gait training with sham brain stimulation

ACTIVE COMPARATOR

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

Device: Treadmill gait training

Interventions

Brain stimulationDEVICE

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

Robot gait training with brain stimulation
Treadmill gait trainingDEVICE

Lokomat robot training was applied to stroke patients.

Gait training with sham brain stimulationRobot gait training with brain stimulation

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 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 INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 19, 2021

First Posted

August 2, 2021

Study Start

August 1, 2021

Primary Completion

March 31, 2022

Study Completion

May 16, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations

KR(1)