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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