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Analysis of Brain Diffusion Tensor Image in Stroke Patients

Analysis of Brain Diffusion Tensor Image in Stroke Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06047223
Enrollment
80
Registered
2023-09-21
Start date
2023-10-05
Completion date
2025-12-31
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

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.

Interventions

DIAGNOSTIC_TESTMagnetic resonanace imaging

Magnetic resonance imaging for measurement of diffustion tensor imaging

Sponsors

Bundang CHA Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Measurement of magnetic resonanace imaging (MRI)Through study completion, an average of 1 dayMRI scan is a process of measuring changes of diffusion tensor tractography

Secondary

MeasureTime frameDescription
Measurement of Korean version of Montreal Cognitive Assessment (K-MoCA)Through study completion, an average of 1 dayK-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.
Measurement of clinical dementia rate (CDR)Through study completion, an average of 1 dayCDR 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)
Measurement of Korean version of oxford cognitive screen (OCS-K)visit 1OCS is an assessment of major cognitive domains of memory, language, number, praxis, executive functions and attention.
Measurement of digit span test.Through study completion, an average of 1 dayDigit 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.
Measurement of Korean version of western aphasia battery (K-WAB)Through study completion, an average of 1 dayK-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.
Measurement of motricity index (MI)Through study completion, an average of 1 dayMI is a process of the evaluating the function and strength of upper, lower extremities and trunk in score.
Measurement of Korean version of coma recovery scale-revised (K-CRSR)Through study completion, an average of 1 dayK-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.
Measurement of functional ambulatory category (FAC)Through study completion, an average of 1 dayFAC 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.
Measurement of time up and go (TUG)Through study completion, an average of 1 dayTUG 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.
Measurement of Fugl-Meyer assessment (FMA)Through study completion, an average of 1 dayFMA 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.
Measurement of action research arm test (ARAT)Through study completion, an average of 1 dayARAT 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)
Measurement of Korean version of modified barthel index (K-MBI)Through study completion, an average of 1 dayMBI 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
Measurement of motion analysisThrough study completion, an average of 1 dayMotion 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
Measurement of berg balance scale (BBS)Through study completion, an average of 1 dayBBS 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

Countries

South Korea

Contacts

Primary ContactHyun Jung Oh, BS
a210525@chamc.co.kr+82 031 780 6003

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026