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Functional Recovery Changes in Subacute Stroke Patients

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ClinicalTrials.gov Identifier: NCT03428659
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

February 4, 2018
February 9, 2018
March 8, 2018
February 12, 2018
January 31, 2022   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT03428659 on ClinicalTrials.gov Archive Site
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Functional Recovery Changes in Subacute Stroke Patients
Dynamic Time Series Data Collection for Functional Recovery Changes in Sub-acute Stroke Patients
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
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Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
6 Months
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Non-Probability Sample
A person who was inpatient at sub-acute stage at the Samsung Medical Center.
Sub-acute Stroke
Other: Data acquisition of functional abilities in sub-acute stroke
MRI data, motor evoked potentials, gait function and behavior data acquisition
Sub-acute stroke
More than 1 week post-stroke Ischemic or hemorrhagic stroke
Intervention: Other: Data acquisition of functional abilities in sub-acute stroke
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
138
Same as current
January 31, 2022
January 31, 2022   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact: Kim Yun-Hee, MD, PhD +82-2-3410-2818 yun1225.kim@samsung.com
Contact: Hwang-Jae Lee, PT, PhD +82-2-6007-5452 goodptlee@gmail.com
Korea, Republic of
 
 
NCT03428659
2017-11-081
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
January 2018