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

Sponsor

National Rehabilitation Center, Seoul, Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT03991364

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Constant gait speed group Other: Increasing gait speed group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Constant gait speed group

experimental group that applied the speed of the robot-assisted gait training constantly

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

control group that applied the gradual increase of the speed of the robot-assisted gait training

Other: Increasing gait speed group

The speed of the robot-assisted gait treatment is gradually increase for 5 times a week for 2 weeks.

Outcome Measures

Primary Outcome Measures

Energy expenditure (EE) [2 weeks after baseline]
EE(kcal/min): energy expenditure per minute

Secondary Outcome Measures

Energy expenditure (EE) [baseline, 1 weeks after baseline, 3 weeks after baseline]
EE(kcal/min): energy expenditure per minute
Heart rate (HR) [baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline]
Cardiac frequency
Volume of Oxygen (VO2) [baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline]
O2 consumption/1min
Respiratory Quotient (R) [baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline]
Respiratory quotient
Metabolic equivalent (METS) [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) [baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline]
oxygenated hemoglobin concentration of cortical activation
deoxygenated hemoglobin (DeoxyHb) [baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline]
deoxygenated hemoglobin concentration of cortical activation
Lower extremity Fugl-Meyer Assessment [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Rehabilitation Center	Seoul		Korea, Republic of	142884

Sponsors and Collaborators

National Rehabilitation Center, Seoul, Korea

Investigators

Principal Investigator: Joon-Ho Shin, MS, National Rehabilitation Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea

ClinicalTrials.gov Identifier:

NCT03991364

Other Study ID Numbers:

NRC-2019-01-002

First Posted:

Jun 19, 2019

Last Update Posted:

Jun 19, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea

Robot-assisted gait training

stroke

gait speed

Additional relevant MeSH terms:

Stroke

Methamphetamine

Study Results

No Results Posted as of Jun 19, 2019