The Effect of Simultaneous Application of Transcranial Direct Current Stimulation (tDCS) and Gait Training for Parkinson's Disease Patients on Gait Function Improvement

Samsung Medical Center1 site in 1 country24 target enrollmentNovember 3, 2020

ConditionsParkinson Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Samsung Medical Center
Enrollment: 24
Locations: 1
Primary Endpoint: Change in 10 meter walk test from baseline in gait speed
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to investigate the effect of simultaneous application of transcranial direct current stimulation (tDCS) and treadmill gait training for gait function recovery in Parkinson's disease patients with gait impairment.

Registry

clinicaltrials.gov

Start Date

November 3, 2020

End Date

June 18, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Yun-Hee Kim

Professor

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

•Age: 50 - 75 years
•Modified Hoehn and Yahr stages 1 to 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 (Korean-Mini-Mental State Examination, K-MMSE≤10)
•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 4 weeks); after 4 weeks 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 Berg Balance Scale (BBS) from baseline in balance(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) from baseline in balance(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))
Changes in motor evoked potentia(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)])
Changes in Functional Reach Test (FRT) from baseline(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)])
Change in muscle manual test (MMT) and range of motion (ROM) from baseline(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)])
Change in Unified Parkinson's Disease Rating Scale (UPDRS) from baseline(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)])
Change in Korean Mini-Mental State Examination (K-MMSE) from baseline(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)])
Change in Geriatric Depression Scale (GDS) from baseline(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)])