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Clinical Trials/NCT03428659
NCT03428659
Completed
N/A

Dynamic Time Series Data Collection for Functional Recovery Changes in Sub-acute Stroke Patients

Samsung Medical Center1 site in 1 country94 target enrollmentJanuary 10, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sub-acute Stroke
Sponsor
Samsung Medical Center
Enrollment
94
Locations
1
Primary Endpoint
Mechanism of recovery of motor function according to recovery of sub-acute stroke
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

In subacute stroke patients, dynamic time series data of brain imaging and motor function measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset

Registry
clinicaltrials.gov
Start Date
January 10, 2018
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • at least 19 years of age hemiplegic stroke patients
  • Subacute-phase ischemic or hemorrhagic stroke patients within 7 days of onset
  • Functional Ambulation Category Scale (FAC) of 3 or less, 7 days of onset,
  • A person who understands and voluntarily participates in this study and signs a research agreement

Exclusion Criteria

  • User of artificial heartbeat
  • Patients with claustrophobia
  • Patients with metal implants
  • Patients who are contraindicated for other common MRI
  • Patients with mild motor impairment with an FMA score of 80 or higher
  • Patients whose conscious state is coma and who have no response at all
  • Patients who can not independently gait with the Modified Rankin Scale (mRS) score of 4 or more before the onset of disease

Outcomes

Primary Outcomes

Mechanism of recovery of motor function according to recovery of sub-acute stroke

Time Frame: Through study completion, an average of 6 months

Mechanism of recovery of motor function calculate by repeated measurement method in physical and cognitive functions data and MRI data of brain

Mechanism of recovery of gait function according to recovery of sub-acute stroke

Time Frame: Through study completion, an average of 6 months

Mechanism of recovery of motor function calculate by repeated measurement method in 3D motion capture system and electromyography (EMG) data and MRI data of brain

Study Sites (1)

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