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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03991364
• Other study ID #: NRC-2019-01-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2019
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: Joon-Ho Shin, MS
• Phone: 82-2-901-1884
• Email: asfreelyas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Constant gait speed group
The speed of the robot-assisted gait treatment is constantly applied for 5 times a week for 2 weeks.
• Increasing gait speed group
The speed of the robot-assisted gait treatment is gradually increase for 5 times a week for 2 weeks.

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy expenditure (EE)	EE(kcal/min): energy expenditure per minute	2 weeks after baseline
Secondary	Energy expenditure (EE)	EE(kcal/min): energy expenditure per minute	baseline, 1 weeks after baseline, 3 weeks after baseline
Secondary	Heart rate (HR)	Cardiac frequency	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Secondary	Volume of Oxygen (VO2)	O2 consumption/1min	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Secondary	Respiratory Quotient (R)	Respiratory quotient	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Secondary	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
Secondary	oxygenated hemoglobin (OxyHb)	oxygenated hemoglobin concentration of cortical activation	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Secondary	deoxygenated hemoglobin (DeoxyHb)	deoxygenated hemoglobin concentration of cortical activation	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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