Analysis of Brain Diffusion Tensor Image in Stroke Patients

November 14, 2023 updated by: MinYoung Kim, MD, PhD, Bundang CHA Hospital
This clinical study aims to confirm the characteristics of the functional ansiotropy value according to the individual characteristics of stroke patients by taking brain diffusion tensor images for stroke patients and using the MRI. To compare hematologic indicators and neurological function levels of stroke patients at the time of imaging examination with brain diffusion tensor imaging indicators.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

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

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
        • Recruiting
        • CHA Bundang Medical Center, CHA University
        • Contact:
          • Minyoung Kim, M.D., Ph.D.
          • Phone Number: 82-31-780-1872
          • Email: kmin@cha.ac.kr
        • Contact:
        • Principal Investigator:
          • Minyoung Kim, M.D., Ph.D.
        • Sub-Investigator:
          • Seyoung Shin, M.D.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Stroke patients

Description

Inclusion Criteria:

  1. Adults aged 20 years or older with a history of stroke
  2. After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions

Exclusion Criteria:

Patients who meet one or more of the following cannot participate in the study.

  1. Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
  2. In the case of a person with impaired consent, a person without a guardian
  3. Patients who have devices that may be affected by MRI, such as pacemakers, spinal cord stimulators, cochlear implants, VP shunts, and nerve stimulators, inserted into the body
  4. Other cases where the researcher judges that participation in this study is not suitable (This study is not an interventional study, and patients who are participating in other clinical trials or studies or who have participated in other clinical trials or studies within the past 30 days can also participate in this study.)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of magnetic resonanace imaging (MRI)
Time Frame: Through study completion, an average of 1 day
MRI scan is a process of measuring changes of diffusion tensor tractography
Through study completion, an average of 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Korean version of coma recovery scale-revised (K-CRSR)
Time Frame: Through study completion, an average of 1 day
K-CRSR is Korean version of standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. he scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness.
Through study completion, an average of 1 day
Measurement of Korean version of Montreal Cognitive Assessment (K-MoCA)
Time Frame: Through study completion, an average of 1 day
K-MoCA is a measurement to evaluate the memory loss or other symptoms of cognitive decline. It contains 30 questions and taskes around to 12 minutes to complete. Scores range from 0 to 30. A score of 26 and higher is considered normal.
Through study completion, an average of 1 day
Measurement of clinical dementia rate (CDR)
Time Frame: Through study completion, an average of 1 day
CDR is a rating scale for staging patients diagnosed with dementia. The CDR evaluates cognitive, behavioral and functional aspects of Alzheimer disease and other dementias. It is calculated on the basis of testing six different cognitive and behavioral domains such as memory, orientation, judgment and problem sloving, community affairs, home and hobbies performance, and personal care. The CDR is based on a scale of 0-3: no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2) and severe cognitive impairment (CDR = 3)
Through study completion, an average of 1 day
Measurement of Korean version of oxford cognitive screen (OCS-K)
Time Frame: visit 1
OCS is an assessment of major cognitive domains of memory, language, number, praxis, executive functions and attention.
visit 1
Measurement of digit span test.
Time Frame: Through study completion, an average of 1 day
Digit span test is a measurment to assess the storage capacity of a person's working memory. A testperson is visually or auditorily to a sequence of digits on after another. Right afterwards, the test subject has to recall the correct digits in the same order.
Through study completion, an average of 1 day
Measurement of digit span test.
Time Frame: Through study completion, an average of 1 day
inhibit cognitie interference. The stroop test consists of colors that are writen in words but in the wrong color ink, The test-taker has to be able to state the color that the word is written in and be able to ignore whatever the actual word is.
Through study completion, an average of 1 day
Measurement of Korean version of western aphasia battery (K-WAB)
Time Frame: Through study completion, an average of 1 day
K-WAB is designed as an assessment tool to examine linguistic skills (information content, fluency, auditory comprehension, repetition, naming and word finding, reading, and writing) and main nonlinguistic skills (drawing, block design, calculation, and praxis) of adults with aphasia.
Through study completion, an average of 1 day
Measurement of motricity index (MI)
Time Frame: Through study completion, an average of 1 day
MI is a process of the evaluating the function and strength of upper, lower extremities and trunk in score.
Through study completion, an average of 1 day
Measurement of berg balance scale (BBS)
Time Frame: Through study completion, an average of 1 day
BBS is a measurement of balancing function. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total score = 56
Through study completion, an average of 1 day
Measurement of functional ambulatory category (FAC)
Time Frame: Through study completion, an average of 1 day
FAC is a measurement of a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use personal assistive device.
Through study completion, an average of 1 day
Measurement of time up and go (TUG)
Time Frame: Through study completion, an average of 1 day
TUG is a measurement of a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. 11-20 seconds are within normal limits for frail elderly and disables patients, and greater than 20 seconds means the person needs assistance outside and indicates further examintaiton and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Through study completion, an average of 1 day
Measurement of Fugl-Meyer assessment (FMA)
Time Frame: Through study completion, an average of 1 day
FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sesation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research determine disease severity, describe motor recovery, and to plan and assess treatment.
Through study completion, an average of 1 day
Measurement of action research arm test (ARAT)
Time Frame: Through study completion, an average of 1 day
ARAT is a 19 item observational measurement to assess upper extremity performance (coordination, dexterity and functioning). Items comprising ARAT are categorized into four subscales (grasp, grip, pinch and gross movement). Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performend normally)
Through study completion, an average of 1 day
Measurement of Korean version of modified barthel index (K-MBI)
Time Frame: Through study completion, an average of 1 day
MBI is a measurement of degree of independence of a patient from any assistance. It covers 10 domains of daily activities: bowel and bladder control, grooming, toilet use, feeding, trasnfers, walking, dressing, climbing stairs and bathing
Through study completion, an average of 1 day
Measurement of motion analysis
Time Frame: Through study completion, an average of 1 day
Motion analysis is a process of measuring and evaluating gait function in kinetic parameters of range of motion in angle of each joint by degree throguh Qualisys motion analysis system
Through study completion, an average of 1 day
Measurement of motion analysis
Time Frame: Through study completion, an average of 1 day
Motion analysis is a process of measuring and evaluating gait function and kinematic parameters including moment (Nm/kg) of each joint throguh Qualisys motion analysis system
Through study completion, an average of 1 day
Measurement of motion analysis
Time Frame: Through study completion, an average of 1 day
Motion analysis is a process of measuring and evaluating gait function and kinematic parameters including power (Nm/s*kg) of each joint throguh Qualisys motion analysis system
Through study completion, an average of 1 day
Measurement of motion analysis
Time Frame: Through study completion, an average of 1 day
Motion analysis is a process of measuring and evaluating gait function and kinematic parameters including ground reaction force (N/kg) of each joint throguh Qualisys motion analysis system
Through study completion, an average of 1 day

Collaborators and Investigators

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

Sponsor

Bundang CHA Hospital

Investigators

  • Principal Investigator: Minyoung Kim, M.D., Ph.D., Bundang CHA Hospital

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)

October 5, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-08-005

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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