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

National Rehabilitation Center, Seoul, Korea1 site in 1 country30 target enrollmentSeptember 1, 2018

ConditionsStroke

Overview

Phase: N/A
Intervention: Not specified
Conditions: Stroke
Sponsor: National Rehabilitation Center, Seoul, Korea
Enrollment: 30
Locations: 1
Primary Endpoint: Range of motion of ankle, knee, and hip joint
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 1, 2018

End Date

December 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Rehabilitation Center, Seoul, Korea

Responsible Party

Principal Investigator

Joon-Ho Shin

Team manager

National Rehabilitation Center, Seoul, Korea

Eligibility Criteria

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

Outcomes

Primary Outcomes

Range of motion of ankle, knee, and hip joint

Time Frame: 4 weeks from baseline

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

oxygenated hemoglobin levels

Time Frame: 4 weeks from baseline

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

Secondary Outcomes

Plantar pressure(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Functional ambulation category(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Timed up and go test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Balance test using force plate(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Fugl-Meyer Assessment(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Stroke impact scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
dual task - COWAT(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Electromyography of lower extremities(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
modified Barthel index(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Spatiotemporal gait parameter data(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
total hemoglobin levels(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Range of motion of ankle, knee, and hip joint(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
dual task - digit span test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
deoxygenated hemoglobin levels(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
oxygenated hemoglobin levels(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Berg Balance Scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
10m walk test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Falls efficacy scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Beck depression inventory(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Dynamic gait index(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)