Clinical trial NCT04985864: Effect of Simultaneous Application of HD-tDCS and Robot-assisted Gait Training on Gait Function in Stroke Patients
Official title: A Study on Effect of Simultaneous Application of Transcranial Direct Current Stimulation (tDCS) and Robotic Gait Training on Gait Function in Stroke Patients With Gait Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ybrain Inc.
First posted: 2021-08-02
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in 10 meter walk test
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
Secondary outcomes:
measure: Change in Berg Balance Scale (BBS)
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
measure: Change in Timed Up and Go test (TUG)
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
measure: Changes in Brain activation of resting-state functional MRI
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks)
measure: Change in Geriatric Depression Scale (GDS)
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
measure: Changes in motor evoked potential
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
measure: Change in Fugl-Meyer Assessment
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
measure: Change in Functional ambulatory category
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
measure: Change in Modified Bathel index (MBI)
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
measure: Change in Muscle Manual Test (MMT)
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
measure: Change in Range of Motion (ROM)
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
measure: Change in Modified Ashworth Scale(MAS)
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: