StrokeNCT05908994
A Study for the Collection of Clinical Data for Stroke Patients and Healthy Subjects
An observational study of Stroke and Health Behavior, run by Bundang CHA Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Health Behavior
- What is being tested?
- Examination
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Oct 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients and healthy voluteers
- 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.)
- 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
- 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.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Medicine, CHA Bundang Medical Center
Seongnam, 13496
MinYoung Kim, MD,PhD
About this study
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.
- Conditions
- Stroke, Health Behavior
- Being tested
- Examination
- Medical subject headings
- Stroke, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExaminationOther
Exmainations including imaging, neurophysiological, kinetic and kinematic measurmetns. Behavioral assessments
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motion analysis
Motion analysis is a process of measuring and evaluating gait function in kinetic and kinematic parameters
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
Secondary outcomes (30)
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
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in computed tomogrphy (CT)
CT scan is a process of measuring and detecting the structural changes of spine
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in magnetic resonanace imaging (MRI)
MRI scan is a process of measuring changes of diffusion tensor tractography
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in motricity index (MI)
MI is a process of the evaluating the function and strength of upper, lower extremities and trunk in score
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in range of motion (ROM)
ROM testing is a measurement of movement around a specific joint of body part in angle
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in Gait rite
Gait rite is a measurement of a temporal and spatial parameters during gait
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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)
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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)
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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)
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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".
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in Oxford cognitive screen (OCS)
OCS is an assessment of major cognitive domains of memory, language, number, praxis, executive functions and attention.
Measured: 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)
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
Changes in Rey-kim test
Rey-kim test is a measurement for assessing memory quotient including auditory verbal learning test and complex figure test
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
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.
Measured: Change from baseline to 6 months, 12 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start6 Oct 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908994
- Sponsor's protocol ID
- 2021-05-026
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bak SY, Chung EH, Kim H, Shin S, Jeon H, Kim M. Comparison of gait parameters between patients with chronic stroke at different ambulation levels and healthy adults: a prospective observational study. BMC Sports Sci Med Rehabil. 2025 Dec 1;18(1):9. doi: 10.1186/s13102-025-01444-4.
PubMed 41327370
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for the Collection of Clinical Data for Stroke Patients and Healthy Subjects
- ClinicalTrials.gov ID
- NCT05908994
- Acronym / sponsor ID
- 2021-05-026
- Conditions
- Stroke, Health Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients and healthy voluteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExaminationExmainations including imaging, neurophysiological, kinetic and kinematic measurmetns. Behavioral assessments | Other | – |
Primary outcome
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
30 secondary outcomes
Changes in X-ray radiography
Time frame: 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
Changes in magnetic resonanace imaging (MRI)
Time frame: 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
Changes in motricity index (MI)
Time frame: 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
Changes in berg balance scale (BBS)
Time frame: 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
Changes in trunk impairment scale (TIS)
Time frame: 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
Changes in Gait rite
Time frame: 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
Changes in Fugl-meyer assessement (FMA)
Time frame: 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
Changes in fuctional independence meausure (FIM)
Time frame: 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
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
Changes in stroke specific quality of life (SS-QoL)
Time frame: 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
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
Changes in clinical dementia rating (CDR)
Time frame: 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
Changes in geriatric depression scale (GDS)
Time frame: 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
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
Changes in Rey-kim test
Time frame: 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
Changes in stroop test
Time frame: 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
Changes in evoked potentials (EP)
Time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 41327370Bak SY, Chung EH, Kim H, Shin S, Jeon H, Kim M. Comparison of gait parameters between patients with chronic stroke at different ambulation levels and healthy adults: a prospective observational study. BMC Sports Sci Med Rehabil. 2025 Dec 1;18(1):9. doi: 10.1186/s13102-025-01444-4.
- Individual participant dataSharing planned: Yes
Related trials for Stroke
Not yet recruiting
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Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
Acute Ichemic Stroke
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingPhase 2
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
Chronic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Health Behavior, run by Bundang CHA Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Jung Oh, Bachelor's degree (+82 031 780 6003, a210525@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in motion analysis (time frame: Change from baseline to 6 months, 12 months, 18 months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05908994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.