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

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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Robot-assisted gait training; Device: Treadmill gait training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 142884
    • National Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted gait training; experimental group that applied the end-effector robot-assisted gait training	Device: Robot-assisted gait training; intervention with robot-assisted gait training
Active Comparator: Treadmill gait training; control group that applied the treadmill gait training	Device: Treadmill gait training; intervention with treadmill gait training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygenated hemoglobin levels	cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait	4 weeks from baseline
Range of motion of ankle, knee, and hip joint	ankle, knee, and hip joint motion of sagittal plane during gait	4 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygenated hemoglobin levels	cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Range of motion of ankle, knee, and hip joint	ankle, knee, and hip joint motion of sagittal plane during gait	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck depression inventory	21-question multiple-choice self-report inventory, one of the most widely used psychometric tests	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Dynamic gait index	a clinical tool to assess gait, balance and fall risk	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Timed up and go test	a simple test used to assess a person's mobility and requires both static and dynamic balance	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
modified Barthel index	Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
dual task - digit span test	The digit span test is a way of measuring the storage capacity of a person's working memory.	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Electromyography of lower extremities	Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Plantar pressure	Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Spatiotemporal gait parameter data	step length, step time, swing time, double limb support time during gait	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
deoxygenated hemoglobin levels	cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
total hemoglobin levels	cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Balance test using force plate	Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

Collaborators and Investigators

• Sponsor: National Rehabilitation Center, Seoul, Korea

Publications and helpful links

General Publications

• Kim H, Park G, Shin JH, You JH. Neuroplastic effects of end-effector robotic gait training for hemiparetic stroke: a randomised controlled trial. Sci Rep. 2020 Jul 27;10(1):12461. doi: 10.1038/s41598-020-69367-3.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 9, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: stroke; robot-assisted gait training; cortical activity; gait kinematics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NRC-2017-02-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No