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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
tDCS brain stimulation on leg motor areas was applied to Parkinson patients.
Treadmill gait training was applied to Parkinson patients.
Samsung Medical Center
Seoul, South Korea
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."
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Change in Berg Balance Scale (BBS) from baseline in balance
Mesure of blance function. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56.
Time frame: 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
Meserue of dynamic blance function. 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Time frame: 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
Meserue of Neuroplasticity
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks)
Changes in motor evoked potentia
Measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.
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Time frame: 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
FRT is a single item test developed as a quick screen for balance problems. Measurement Interpretation: 10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal
Time frame: 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
Meserue of MMT and ROM of lower extremity.
Time frame: 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
Meserue of Parkinson disease motor level. 1\) nonmotor experiences of daily living (13 items), (2) motor experiences of daily living (13 items), (3) motor examination (18 items), and (4) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Time frame: 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
Meserue of cognition level. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.
Time frame: 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
Meserue of depression. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]