Functional Recovery Changes in Subacute Stroke Patients

Sub-acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428659
• Other study ID #: 2017-11-081
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Sub-acute Stroke

Intervention

Other:
• Data acquisition of functional abilities in sub-acute stroke
MRI data, motor evoked potentials, gait function and behavior data acquisition

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanism of recovery of motor function according to recovery of sub-acute stroke	Mechanism of recovery of motor function calculate by repeated measurement method in physical and cognitive functions data and MRI data of brain	Through study completion, an average of 6 months
Primary	Mechanism of recovery of gait function according to recovery of sub-acute stroke	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	Through study completion, an average of 6 months