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

June 8, 2023 updated by: MinYoung Kim, MD, PhD, Bundang CHA Hospital
This study aimes to medical data, musculoskeletal data and functional data over time of stroke patients and healthy subjects to compared the clinical differences between stroke and healthy subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hyun Jung Oh, Bachelor's degree
  • Phone Number: +82 031 780 6003
  • Email: a210525@chamc.co.kr

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 13496
        • Recruiting
        • Department of Rehabilitation Medicine, CHA Bundang Medical Center
        • Contact:
          • MinYoung Kim, MD,PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Stroke patients and healthy voluteers

Description

  1. For stroke patients 1) Inclusion Criteria:

    • Adults over 20 years of age
    • More than 1 month after onset of stroke
    • 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 2) Exclusion criteria:
    • Patients who correspond to one or more of the following cannot participate in the study.
    • Patients with systemic infectious symptoms at the time of participation in the study
    • In the case of a person with impaired ability to consent (less than 10 points on the MMSE), a person who is not accompanied by a guardian
    • 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
    • Other cases where the researcher judges that participation in this study is not suitable(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.)

  2. For healthy voluteers 1) Inclusion Criteria:

    • Over 20 years of age
    • A person who is performing an independent daily life

    • A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing a detailed explanation of this study and fully understanding it

      2) Exclusion criteria:

    • Patients who correspond to one or more of the following cannot participate in the study.
    • MMSE score less than 20 points (from 19 points onwards excluded from study)
    • Those who remain disabled due to brain disease (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
    • 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
    • Other cases where the researcher judges that participation in this study is not suitable (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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in motion analysis
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
Motion analysis is a process of measuring and evaluating gait function in kinetic and kinematic parameters
Change from baseline to 6 months, 12 months, 18 months and 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in X-ray radiography
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
X-ray radiography is a process of measuring and detecting the structural changes of bones including thorax, whole spine, lower extremity
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in computed tomogrphy (CT)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
CT scan is a process of measuring and detecting the structural changes of spine
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in magnetic resonanace imaging (MRI)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
MRI scan is a process of measuring changes of diffusion tensor tractography
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in manual muscle test (MMT)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in motricity index (MI)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
MI is a process of the evaluating the function and strength of upper, lower extremities and trunk in score
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in range of motion (ROM)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
ROM testing is a measurement of movement around a specific joint of body part in angle
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in berg balance scale (BBS)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in motor assessment scale (MAS)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in trunk impairment scale (TIS)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in functional ambulatory category (FAC)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in Gait rite
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
Gait rite is a measurement of a temporal and spatial parameters during gait
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in time up and go test (TUG)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in Fugl-meyer assessement (FMA)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in action research arm test (ARAT)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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)
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in fuctional independence meausure (FIM)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in modified barthel-index (MBI)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in national institute of health care stroke scale (NIHSS)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in stroke specific quality of life (SS-QoL)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in Korean version of Montreal cognitive assessment (K-MoCA)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in Korean version of mini-mental state examination (K-MMSE)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in clinical dementia rating (CDR)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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)
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in global deterioration scale (GDS)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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)
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in geriatric depression scale (GDS)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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".
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in Oxford cognitive screen (OCS)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
OCS is an assessment of major cognitive domains of memory, language, number, praxis, executive functions and attention.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in Korean version of Wechsler adult intelligence scale 4th edition (K-WAIS-IV)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in Rey-kim test
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
Rey-kim test is a measurement for assessing memory quotient including auditory verbal learning test and complex figure test
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in digit span test
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in stroop test
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in electroencephalogrphy (EEG)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
EEG is a measurement of electrical activity in the brain using small electrodes attached to the scalp for diagnosting brain disorders.
Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in evoked potentials (EP)
Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Change from baseline to 6 months, 12 months, 18 months and 24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-05-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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