Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke

Study Overview
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Brief Summary
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Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke

Official Title
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Effects of Robotic Gait Training on Cortical Activity and Gait Function in Hemiparetic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Robot-assisted gait training
* Device: Treadmill gait training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted gait training<br>experimental group that applied the end-effector robot-assisted gait training | Device: Robot-assisted gait training<br>* intervention with robot-assisted gait training<br>|
| Active Comparator: Treadmill gait training<br>control group that applied the treadmill gait training | Device: Treadmill gait training<br>* intervention with treadmill gait training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenated hemoglobin levels | cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait | 4 weeks from baseline | 
| Range of motion of ankle, knee, and hip joint | ankle, knee, and hip joint motion of sagittal plane during gait | 4 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenated hemoglobin levels | cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Range of motion of ankle, knee, and hip joint | ankle, knee, and hip joint motion of sagittal plane during gait | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Berg Balance Scale | 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. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Fugl-Meyer Assessment | 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. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| 10m walk test | 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. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Functional ambulation category | 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 | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Falls efficacy scale | 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 | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Beck depression inventory | 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Stroke impact scale | 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 | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Dynamic gait index | a clinical tool to assess gait, balance and fall risk | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Timed up and go test | a simple test used to assess a person's mobility and requires both static and dynamic balance | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| modified Barthel index | Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| dual task - COWAT | 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. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| dual task - digit span test | The digit span test is a way of measuring the storage capacity of a person's working memory. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Electromyography of lower extremities | Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Plantar pressure | Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Spatiotemporal gait parameter data | step length, step time, swing time, double limb support time during gait | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| deoxygenated hemoglobin levels | cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| total hemoglobin levels | cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Balance test using force plate | Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot-assisted gait training, cortical activity, gait kinematics, stroke