Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke
- Conditions
- Stroke
- Interventions
- Device: Robot-assisted gait trainingDevice: Treadmill gait training
- Registration Number
- NCT04054739
- Lead Sponsor
- National Rehabilitation Center, Seoul, Korea
- Brief Summary
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Hemiplegic patients secondary to first cerebrovascular accidents
- Functional ambulation category score 3
- 3 months ≤ Onset ≤ 12 months
- Korean Mini-Mental State Examination score > 24
- History of surgery of affected lower limb
- Fracture of affected lower limb
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robot-assisted gait training Robot-assisted gait training experimental group that applied the end-effector robot-assisted gait training Treadmill gait training Treadmill gait training control group that applied the treadmill gait training
- Primary Outcome Measures
Name Time Method Range of motion of ankle, knee, and hip joint 4 weeks from baseline ankle, knee, and hip joint motion of sagittal plane during gait
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
- Secondary Outcome Measures
Name Time Method 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
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
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
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
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.
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
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.
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.
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
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
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
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
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.
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
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
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.
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.
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
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
Trial Locations
- Locations (1)
National Rehabilitation Center
🇰🇷Seoul, Korea, Republic of