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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054739
• Other study ID #: NRC-2017-02-015
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Robot-assisted gait training
intervention with robot-assisted gait training
• Treadmill gait training
intervention with treadmill gait training

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	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
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, 2 weeks after baseline, 4 weeks after baseline, 8 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, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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