A Study for the Collection of Clinical Data for Stroke Patients and Healthy Subjects

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• Stroke 7,286

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 100 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Lead sponsor

Bundang CHA Hospital is the lead sponsor of 34 studies on the registry; 17 are open to participants now.

Study population

Eligibility criteria

Interventions

• OtherExamination

  Exmainations including imaging, neurophysiological, kinetic and kinematic measurmetns. Behavioral assessments

Primary outcomes

1. Changes in motion analysis

   Motion analysis is a process of measuring and evaluating gait function in kinetic and kinematic parameters

   Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

Secondary outcomes

1. Changes in X-ray radiography

   X-ray radiography is a process of measuring and detecting the structural changes of bones including thorax, whole spine, lower extremity

   Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

2. Changes in computed tomogrphy (CT)

   CT scan is a process of measuring and detecting the structural changes of spine

   Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

3. Changes in magnetic resonanace imaging (MRI)

   MRI scan is a process of measuring changes of diffusion tensor tractography

   Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

4. Changes in manual muscle test (MMT)

   MMT is a process of the evaluating the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance in score

   Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

5. Changes in motricity index (MI)

   MI is a process of the evaluating the function and strength of upper, lower extremities and trunk in score

   Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

6. Changes in range of motion (ROM)

   ROM testing is a measurement of movement around a specific joint of body part in angle

   Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

7. Changes in berg balance scale (BBS)

   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

   Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

8. Changes in motor assessment scale (MAS)

   MAS is a measurement of performance-based scale for assessing everyday motor function. The MAS is comprised of 8 items corresponding to 8 areas of motor function. All items are assessed using a 7-point scale from 0-6.

   Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

9. Changes in trunk impairment scale (TIS)

   MAS is a measurement of static and dynamic sitting balance and trunck coordination in a sitting position. For each item, a 2-, 3- or 4- point ordinal scale is used. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.

   Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

10. Changes in functional ambulatory category (FAC)

    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.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

11. Changes in Gait rite

    Gait rite is a measurement of a temporal and spatial parameters during gait

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

12. Changes in time up and go test (TUG)

    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.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

13. Changes in Fugl-meyer assessement (FMA)

    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.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

14. Changes in action research arm test (ARAT)

    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)

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

15. Changes in fuctional independence meausure (FIM)

    FIM is a measurment to evaluate the funciontional status. FIS is an 18-item including functional capability in six areas of self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items are graded on a scale of 1-7, based on the level of independence in that item

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

16. Changes in modified barthel-index (MBI)

    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 bating

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

17. Changes in national institute of health care stroke scale (NIHSS)

    NIHSS is a measurement for assessing the severity of stroke patients. The scale is made up of 11 different elements that evaluate specific ability. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. 42 is the highest score possible, the higher the score, the more impaired a stroke patient is.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

18. Changes in stroke specific quality of life (SS-QoL)

    SS-QoL is an instrument designed to measure th quality of life (QOL) of stroke population and is intended to identify common areas that affect health-related QoL. The assessment is composed of 49 items within 12 domains that include such items as energy, family roles, mobility, and self-care. The SS-QoL has a score range of 49 to 245 with higher scores indicating better HR-QoL.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

19. Changes in Korean version of Montreal cognitive assessment (K-MoCA)

    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.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

20. Changes in Korean version of mini-mental state examination (K-MMSE)

    K-MMSE is a measurement of cognitive level. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe(≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainement and age.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

21. Changes in clinical dementia rating (CDR)

    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)

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

22. Changes in global deterioration scale (GDS)

    GDS is a clinical rating instrument created to assess stages of primary degenerative dementia, namley, Alzhemier's disease (AD). It is classified seven stages: stage 1 (no cognitive decline), stage 2 (very mild cognitive decline), stage 3 (mild cognitive decline), stage 4 (moderated cognitive decline), stage 5 (moderately severe cognitive decline), stage 6 (severe cognitive decline), stage 7 (very severe cognitive decline)

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

23. Changes in geriatric depression scale (GDS)

    GDS is a 30-item self-report assessment used to identify depression in the elderly. One point is assigned to each answer and the cumulative score is rated on a scroing grid. The grid sets a range of 0-9 as "normal", "10-19" as "mildly depressed", and 20-30 as "severely depressed".

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

24. Changes in Oxford cognitive screen (OCS)

    OCS is an assessment of major cognitive domains of memory, language, number, praxis, executive functions and attention.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

25. Changes in Korean version of Wechsler adult intelligence scale 4th edition (K-WAIS-IV)

    K-WAIS-IV is a measurment for intelligence and cognitive ability in adults and older adolscents. There are four index scores representing major components of intelligence including verbal comprehension index, perceptual reasoning index, working memory index, processing speed index.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

26. Changes in Rey-kim test

    Rey-kim test is a measurement for assessing memory quotient including auditory verbal learning test and complex figure test

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

27. Changes in digit span test

    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.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

28. Changes in stroop test

    Stroop test is a meausrment to assess the ability to 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.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

29. Changes in electroencephalogrphy (EEG)

    EEG is a measurement of electrical activity in the brain using small electrodes attached to the scalp for diagnosting brain disorders.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

30. Changes in evoked potentials (EP)

    Measurement evoked potentials including sensory and motor evoked potentials. An evoked potential is the electrical response fo the brain to a sensory or motor stimulus.

    Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

Individual participant data

Plan to share: Yes