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
1 other identifier
interventional
30
1 country
1
Brief Summary
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 11, 2020
February 1, 2020
1.2 years
August 12, 2019
February 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (20)
oxygenated 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
Berg Balance Scale
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
10m walk test
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
- +15 more secondary outcomes
Study Arms (2)
Robot-assisted gait training
EXPERIMENTALexperimental group that applied the end-effector robot-assisted gait training
Treadmill gait training
ACTIVE COMPARATORcontrol group that applied the treadmill gait training
Interventions
intervention with robot-assisted gait training
Eligibility Criteria
You may qualify if:
- Hemiplegic patients secondary to first cerebrovascular accidents
- Functional ambulation category score 3
- months ≤ Onset ≤ 12 months
- Korean Mini-Mental State Examination score \> 24
You may not qualify if:
- History of surgery of affected lower limb
- Fracture of affected lower limb
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Rehabilitation Center
Seoul, 142884, South Korea
Related Publications (1)
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.
PMID: 32719420DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joon-Ho Shin, MS
National Rehabilitation Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Team manager
Study Record Dates
First Submitted
August 12, 2019
First Posted
August 13, 2019
Study Start
September 1, 2018
Primary Completion
November 30, 2019
Study Completion
December 31, 2019
Last Updated
February 11, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share