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

Primary Purpose

Stroke

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Constant gait speed group

Increasing gait speed group

About this trial

This is an interventional treatment trial for Stroke focused on measuring Robot-assisted gait training, stroke, gait speed

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

National Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Constant gait speed group

Increasing gait speed group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Energy expenditure (EE)

EE(kcal/min): energy expenditure per minute

Secondary Outcome Measures

Energy expenditure (EE)

EE(kcal/min): energy expenditure per minute

Heart rate (HR)

Cardiac frequency

Volume of Oxygen (VO2)

O2 consumption/1min

Respiratory Quotient (R)

Respiratory quotient

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

oxygenated hemoglobin (OxyHb)

oxygenated hemoglobin concentration of cortical activation

deoxygenated hemoglobin (DeoxyHb)

deoxygenated hemoglobin concentration of cortical activation

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.

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

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.

timed up and go test

simple test used to assess a person's mobility and requires both static and dynamic balance

Full Information

NCT ID

NCT03991364

First Posted

June 18, 2019

Last Updated

June 18, 2019

Sponsor

National Rehabilitation Center, Seoul, Korea

1. Study Identification

Unique Protocol Identification Number

NCT03991364

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2019 (Anticipated)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Rehabilitation Center, Seoul, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Robot-assisted gait training, stroke, gait speed

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Constant gait speed group

Arm Type

Experimental

Arm Description

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

Arm Title

Increasing gait speed group

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Constant gait speed group

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Increasing gait speed group

Intervention Description

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

Primary Outcome Measure Information:

Title

Energy expenditure (EE)

Description

EE(kcal/min): energy expenditure per minute

Time Frame

2 weeks after baseline

Secondary Outcome Measure Information:

Title

Energy expenditure (EE)

Description

EE(kcal/min): energy expenditure per minute

Time Frame

baseline, 1 weeks after baseline, 3 weeks after baseline

Title

Heart rate (HR)

Description

Cardiac frequency

Time Frame