Functional Recovery Changes in Subacute Stroke Patients

Completed

• Conditions: Sub-acute Stroke
• Interventions: Other: Data acquisition of functional abilities in sub-acute stroke

• Registration Number: NCT03428659
• Lead Sponsor: 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-10
• Study First Submitted: 2018-02-04
• Study First Submitted QC: 2018-02-04
• Study First Posted: 2018-02-09
• Status Verified: 2019-09
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sub-acute stroke	Data acquisition of functional abilities in sub-acute stroke	More than 1 week post-stroke Ischemic or hemorrhagic stroke

Primary Outcome Measures

Name	Time	Method
Mechanism of recovery of motor function according to recovery of sub-acute stroke	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	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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of