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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

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

Condition or disease Intervention/treatment
Sub-acute Stroke Other: Data acquisition of functional abilities in sub-acute stroke

Study Type : Observational [Patient Registry]
Estimated Enrollment : 138 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Dynamic Time Series Data Collection for Functional Recovery Changes in Sub-acute Stroke Patients
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Group/Cohort Intervention/treatment
Sub-acute stroke
More than 1 week post-stroke Ischemic or hemorrhagic stroke
Other: Data acquisition of functional abilities in sub-acute stroke
MRI data, motor evoked potentials, gait function and behavior data acquisition




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A person who was inpatient at sub-acute stage at the Samsung Medical Center.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428659


Contacts
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

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Yun-Hee Kim, MD, PhD       yun1225.kim@samsung.com   
Contact: Hwang-Jae Lee, PT, PhD       goodptlee@gmail.com   
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03428659     History of Changes
Other Study ID Numbers: 2017-11-081
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samsung Medical Center:
Motor function
Recovery
Gait
Magnetic resonance imaging

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases