Functional Recovery Changes in Subacute Stroke Patients

February 27, 2023 updated by: Samsung Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A person who was inpatient at sub-acute stage at the Samsung Medical Center.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 6 months
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
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 4, 2018

First Submitted That Met QC Criteria

February 4, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-11-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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