Comparisons of Two Types of Robot Assisted Gait Training

Study Overview
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Brief Summary
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Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial

Official Title
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Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial

Conditions
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Stroke, Robot Assisted Gait Training

Intervention / Treatment
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* Device: exoskeleton type robot
* Device: end-effector type robot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemiplegic patients secondary to first cerebrovascular accidents Ankle dorsiflexor strength: medical research council scale 2 or 3 Functional ambulation category score 3 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
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exoskeleton type robot<br>exoskeleton type robot assisted gait training (Lokomat orthosis) | Device: exoskeleton type robot<br> <br> |
| Experimental: end-effector type robot<br>end-effector type robot assisted gait training (G-EO system) | Device: end-effector type robot<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Range of motion of ankle joint at 4 weeks | ankle joint motion of sagittal plane during gait | 4 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk impairment scale | Trunk impairment scale performs to evaluate the sitting balance and trunk control ability examining static sitting balance, dynamic sitting balance, and coordination, and the maximum score on the subscales are 7, 10, and 6 points, repectively. The total score ranges from 0 to 23 points, a higher score indicating a better trunk performance. | Baseline, 4 weeks from baseline, 8 weeks from 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) floolwing the guidelines of the test develpers, and the maximum score on this test is 56 which indicates balance ability within the normal range. | Baseline, 4 weeks from baseline, 8 weeks from 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, 4 weeks from baseline, 8 weeks from 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, 4 weeks from baseline, 8 weeks from baseline | 
| Korean version of 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, 4 weeks from baseline, 8 weeks from baseline | 
| Range of motion of hip joint | Hip joint motion of sagittal plane during gait | Baseline, 4 weeks from baseline, 8 weeks from baseline | 
| Range of motion of knee joint | knee joint motion of sagittal plane during gait | Baseline, 4 weeks from baseline, 8 weeks from baseline | 
| Range of motion of ankle joint | ankle joint motion of sagittal plane during gait | Baseline, 8 weeks from baseline | 
| Electromyography of lower extremities | Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait. | Baseline, 4 weeks from baseline, 8 weeks from baseline | 
| Plantar pressure | Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait | Baseline, 4 weeks from baseline, 8 weeks from baseline | 
| Step length, time | Step length, stance time, swing time, and stride time during gait | Baseline, 4 weeks from baseline, 8 weeks from 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, 4 weeks from baseline, 8 weeks from baseline |