Comparison of Robot-assisted Gait Training According to Gait Speed in Participants With Stroke

Study Overview
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Brief Summary
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Comparison of the experimental group that applied the speed of the robot-assisted gait training constantly and the control group that applied the gradual increase of the speed of the robot-assisted gait training.

Official Title
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Comparison of Robot-assisted Gait Training According to Gait Speed in Participants With Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: Constant gait speed group
* Other: Increasing gait speed group


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 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Constant gait speed group<br>experimental group that applied the speed of the robot-assisted gait training constantly | Other: Constant gait speed group<br>* The speed of the robot-assisted gait treatment is constantly applied for 5 times a week for 2 weeks.<br>|
| Other: Increasing gait speed group<br>control group that applied the gradual increase of the speed of the robot-assisted gait training | Other: Increasing gait speed group<br>* The speed of the robot-assisted gait treatment is gradually increase for 5 times a week for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy expenditure (EE) | EE(kcal/min): energy expenditure per minute | 2 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy expenditure (EE) | EE(kcal/min): energy expenditure per minute | baseline, 1 weeks after baseline, 3 weeks after baseline | 
| Heart rate (HR) | Cardiac frequency | baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline | 
| Volume of Oxygen (VO2) | O2 consumption/1min | baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline | 
| Respiratory Quotient (R) | Respiratory quotient | baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline | 
| Metabolic equivalent (METS) | the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min | baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline | 
| oxygenated hemoglobin (OxyHb) | oxygenated hemoglobin concentration of cortical activation | baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline | 
| deoxygenated hemoglobin (DeoxyHb) | deoxygenated hemoglobin concentration of cortical activation | baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline | 
| Lower extremity 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, 1 weeks after baseline, 2 weeks after baseline, 3 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, 1 weeks after baseline, 2 weeks after baseline, 3 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, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline | 
| timed up and go test | simple test used to assess a person's mobility and requires both static and dynamic balance | baseline, 1 weeks after baseline, 2 weeks after baseline, 3 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, stroke, gait speed