Clinical trial NCT04054739: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: robot-assisted gait training
cortical activity
gait kinematics
stroke
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2019-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: oxygenated hemoglobin levels
timeFrame: 4 weeks from baseline
measure: Range of motion of ankle, knee, and hip joint
timeFrame: 4 weeks from baseline
Secondary outcomes:
measure: oxygenated hemoglobin levels
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Range of motion of ankle, knee, and hip joint
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Berg Balance Scale
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Fugl-Meyer Assessment
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: 10m walk test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Functional ambulation category
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Falls efficacy scale
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Beck depression inventory
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Stroke impact scale
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Dynamic gait index
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Timed up and go test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: modified Barthel index
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: dual task - COWAT
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: dual task - digit span test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Electromyography of lower extremities
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Plantar pressure
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Spatiotemporal gait parameter data
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: deoxygenated hemoglobin levels
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: total hemoglobin levels
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Balance test using force plate
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
affiliation: National Rehabilitation Center
name: Joon-Ho Shin, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.