Stroke
Conditions
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.
Interventions
DEVICEBrain stimulation
tDCS brain stimulation on leg motor areas was applied to stroke patients.
DEVICETreadmill gait training
Lokomat robot training was applied to stroke patients.
Sponsors
Yun-Hee Kim
Ybrain Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 10 meter walk test | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | Measure of Neuroplasticity |
| Change in Geriatric Depression Scale (GDS) | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | Measure of depression. The grid sets a range of 0-9 as normal, 10-19 as mildly depressed, and 20-30 as severely depressed. |
| Changes in motor evoked potential | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response. |
| Change in Fugl-Meyer Assessment | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured. |
| Change in Berg Balance Scale (BBS) | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | Measurement of balance 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 Modified Bathel index (MBI) | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing. |
| Change in Muscle Manual Test (MMT) | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | Manual muscle testing (MMT) is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance. |
| Change in Range of Motion (ROM) | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part. |
| Change in Modified Ashworth Scale(MAS) | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | measures spasticity with scale from 0 to 3. 0 is no increase in muscle tone. 3 is considerable increase in muscle tone, passive movement difficult. |
| Change in Functional ambulatory category | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. The higher the score, the better the walking ability. |
Countries
South Korea
Outcome results
None listed