Stroke
Conditions
Keywords
robot-assisted gait training, cortical activity, gait kinematics, stroke
Brief summary
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke
Interventions
intervention with robot-assisted gait training
DEVICETreadmill gait training
intervention with treadmill gait training
Sponsors
National Rehabilitation Center, Seoul, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hemiplegic patients secondary to first cerebrovascular accidents * Functional ambulation category score 3 * 3 months ≤ Onset ≤ 12 months * Korean Mini-Mental State Examination score \> 24
Exclusion criteria
* History of surgery of affected lower limb * Fracture of affected lower limb
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oxygenated hemoglobin levels | 4 weeks from baseline | cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait |
| Range of motion of ankle, knee, and hip joint | 4 weeks from baseline | ankle, knee, and hip joint motion of sagittal plane during gait |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life. Each task is scored on a five-point scale (0-4) following the guidelines of the test developers, and the maximum score on this test is 56 which indicates balance ability within the normal range. |
| Fugl-Meyer Assessment | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity. It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment. |
| 10m walk test | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed. |
| Functional ambulation category | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device |
| Falls efficacy scale | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100 |
| Beck depression inventory | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests |
| Stroke impact scale | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | health-related quality of life poststroke across 8 domains using a 5-point Likert scale, with the score ranging from 0 to 100 and a higher score indicating better health status |
| Dynamic gait index | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | a clinical tool to assess gait, balance and fall risk |
| Timed up and go test | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | a simple test used to assess a person's mobility and requires both static and dynamic balance |
| oxygenated hemoglobin levels | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait |
| dual task - COWAT | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | Controlled Oral Word Association Test, abbreviated COWA or COWAT, is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. |
| dual task - digit span test | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | The digit span test is a way of measuring the storage capacity of a person's working memory. |
| Electromyography of lower extremities | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait. |
| Plantar pressure | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait |
| Spatiotemporal gait parameter data | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | step length, step time, swing time, double limb support time during gait |
| deoxygenated hemoglobin levels | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait |
| total hemoglobin levels | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait |
| Balance test using force plate | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area |
| modified Barthel index | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients |
| Range of motion of ankle, knee, and hip joint | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | ankle, knee, and hip joint motion of sagittal plane during gait |
Countries
South Korea
Outcome results
None listed