Comparison of Robot-assisted Gait Training According to Gait Speed in Participants With Stroke
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: December 31, 2020
Interventions
- Other: Constant gait speed group
- The speed of the robot-assisted gait treatment is constantly applied for 5 times a week for 2 weeks.
- Other: Increasing gait speed group
- The speed of the robot-assisted gait treatment is gradually increase for 5 times a week for 2 weeks.
Arms, Groups and Cohorts
- Experimental: Constant gait speed group
- experimental group that applied the speed of the robot-assisted gait training constantly
- Other: Increasing gait speed group
- control group that applied the gradual increase of the speed of the robot-assisted gait training
Clinical Trial Outcome Measures
Primary Measures
- Energy expenditure (EE)
- Time Frame: 2 weeks after baseline
- EE(kcal/min): energy expenditure per minute
Secondary Measures
- Energy expenditure (EE)
- Time Frame: baseline, 1 weeks after baseline, 3 weeks after baseline
- EE(kcal/min): energy expenditure per minute
- Heart rate (HR)
- Time Frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
- Cardiac frequency
- Volume of Oxygen (VO2)
- Time Frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
- O2 consumption/1min
- Respiratory Quotient (R)
- Time Frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
- Respiratory quotient
- Metabolic equivalent (METS)
- Time Frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
- the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min
- oxygenated hemoglobin (OxyHb)
- Time Frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
- oxygenated hemoglobin concentration of cortical activation
- deoxygenated hemoglobin (DeoxyHb)
- Time Frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
- deoxygenated hemoglobin concentration of cortical activation
- Lower extremity Fugl-Meyer Assessment
- Time Frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 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.
- Functional Ambulation Category
- Time Frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 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
- 10m walk test
- Time Frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 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.
- timed up and go test
- Time Frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
- simple test used to assess a person’s mobility and requires both static and dynamic balance
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- National Rehabilitation Center, Seoul, Korea
- Provider of Information About this Clinical Study
- Principal Investigator: Joon-Ho Shin, Team manager – National Rehabilitation Center, Seoul, Korea
- Overall Official(s)
- Joon-Ho Shin, MS, Principal Investigator, National Rehabilitation Center
- Overall Contact(s)
- Joon-Ho Shin, MS, 82-2-901-1884, asfreelyas@gmail.com
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