Parkinson Disease
Conditions
Keywords
transcranial direct current stimulation, gait training, Parkinson's disease
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.
Interventions
DEVICEBrain stimulation
tDCS brain stimulation on leg motor areas was applied to Parkinson patients.
DEVICETreadmill gait training
Treadmill gait training was applied to Parkinson patients.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 10 meter walk test from baseline in gait speed | 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
| Measure | Time frame | Description |
|---|---|---|
| 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)] | 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. |
| Changes in Brain activation of resting-state functional MRI | session 0 (initial visit); session 10 (at approximately 4 weeks) | Meserue of Neuroplasticity |
| Changes in motor evoked potentia | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)] | Measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle. |
| 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)] | 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 |
| 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)] | 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. |
| 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)] | 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. |
| 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)] | 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. |
| 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)] | Meserue of depression. The grid sets a range of 0-9 as normal, 10-19 as mildly depressed, and 20-30 as severely depressed. |
| 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)] | Meserue of MMT and ROM of lower extremity. |
Countries
South Korea
Outcome results
None listed