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Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Robot-assisted gait training

Treadmill gait training

About this trial

This is an interventional treatment trial for Stroke focused on measuring robot-assisted gait training, cortical activity, gait kinematics, stroke

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Hemiplegic patients secondary to first cerebrovascular accidents
Functional ambulation category score 3
3 months ≤ Onset ≤ 12 months
Korean Mini-Mental State Examination score > 24

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

Active Comparator

Arm Label

Robot-assisted gait training

Treadmill gait training

Arm Description

experimental group that applied the end-effector robot-assisted gait training

control group that applied the treadmill gait training

Outcomes

Primary Outcome Measures

oxygenated hemoglobin levels

cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait

Range of motion of ankle, knee, and hip joint

ankle, knee, and hip joint motion of sagittal plane during gait

Secondary Outcome Measures

oxygenated hemoglobin levels

cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait

Range of motion of ankle, knee, and hip joint

ankle, knee, and hip joint motion of sagittal plane during gait

Berg Balance Scale

Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life. Each task is scored on a five-point scale (0-4) following the guidelines of the test developers, and the maximum score on this test is 56 which indicates balance ability within the normal range.

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.

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.

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

Falls efficacy scale

Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100

Beck depression inventory

21-question multiple-choice self-report inventory, one of the most widely used psychometric tests

Stroke impact scale

health-related quality of life poststroke across 8 domains using a 5-point Likert scale, with the score ranging from 0 to 100 and a higher score indicating better health status

Dynamic gait index

a clinical tool to assess gait, balance and fall risk

Timed up and go test

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

modified Barthel index

Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients

dual task - COWAT

Controlled Oral Word Association Test, abbreviated COWA or COWAT, is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter.

dual task - digit span test

The digit span test is a way of measuring the storage capacity of a person's working memory.

Electromyography of lower extremities

Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.

Plantar pressure

Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait

Spatiotemporal gait parameter data

step length, step time, swing time, double limb support time during gait

deoxygenated hemoglobin levels

cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait

total hemoglobin levels

cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait

Balance test using force plate

Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area

Full Information

NCT ID

NCT04054739

First Posted

August 12, 2019

Last Updated

February 9, 2020

Sponsor

National Rehabilitation Center, Seoul, Korea

1. Study Identification

Unique Protocol Identification Number

NCT04054739

Brief Title

Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke

Official Title

Effects of Robotic Gait Training on Cortical Activity and Gait Function in Hemiparetic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

November 30, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

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

Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke

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, cortical activity, gait kinematics, stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Robot-assisted gait training

Arm Type

Experimental

Arm Description

experimental group that applied the end-effector robot-assisted gait training

Arm Title

Treadmill gait training

Arm Type

Active Comparator

Arm Description

control group that applied the treadmill gait training

Intervention Type

Device

Intervention Name(s)

Robot-assisted gait training

Intervention Description

intervention with robot-assisted gait training

Intervention Type

Device

Intervention Name(s)

Treadmill gait training

Intervention Description

intervention with treadmill gait training

Primary Outcome Measure Information:

Title

oxygenated hemoglobin levels

Description

cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait

Time Frame

4 weeks from baseline

Title

Range of motion of ankle, knee, and hip joint

Description

ankle, knee, and hip joint motion of sagittal plane during gait

Time Frame

4 weeks from baseline

Secondary Outcome Measure Information:

Title

oxygenated hemoglobin levels

Description

cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait

Time Frame