StrokeNCT04288414
Prognostic Value for Predicting Outcome Using Functional Near-infrared Spectroscopy in Stroke Rehabilitation
An observational study of Stroke, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
To investigate the prognostic value of Functional Near-Infrared Spectroscopy (fNIRS) in stroke rehabilitation with serial measurements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- functional near-infrared spectroscopy
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Mar 2016to 31 Mar 2024
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients who are receiving rehabilitation.
Who may be able to join
- Age 18 or above.
- Diagnosed as stroke (infarction/hemorrhage) with imaging studies.
- Participants who have given consent after listening to the full explanations of this study.
- Able to understand the contents of this study and is able to sign to the written consent by his/herself.
- A legal representative has given written consent for those who meet the inclusion criteria but is unable to understand and agree by themselves due to impaired cognition, a legal representative.
Who cannot join
- Traumatic brain injury.
- Unable to perform simple commands (motor task during fNIRS scan) due to impaired cognition.
- Current symptoms are caused by diseases other than stroke (e.g., dementia, Parkinson's disease)
- Participants with any symptoms that may hinder the compliance or evaluation (e.g., delirium and agitation) process.
- Participants with any uncontrolled disorders.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, 463-707
About this study
To investigate the prognostic value of Functional Near-Infrared Spectroscopy (fNIRS) in stroke rehabilitation with serial measurements.
Read the detailed description
Serial measurements (immediately after being transferred to rehabilitation department [T0], at discharge from inpatient rehabilitation [T1], and follow up at one to three months from stroke onset [T3]) using Functional Near-Infrared Spectroscopy (fNIRS) was done in all participants. The primary outcome was the outcome prediction rate using fNIRS parameter and clinical parameters. Secondary outcomes were as follows: fNIRS activation pattern, Laterality Index, Functional Connectivity, Fugl-Meyer Score, Modified Barthel Index, , Brunnstrom Stage, Box and Block Test, Grip Strength (handgrip, pinch grip, lateral prehension, three-jaw chuck), Modified Ashworth Scale (wrist flexor and extensor spasticity, elbow flexor, and extensor spasticity, long finger flexor spasticity), modified Rankin Scale score, Functional Ambulation Category, Glasgow Coma Scale, Neglect Evaluation Battery, Korean Version Western Aphasia Battery, and Scale for the Assessment and Rating of Ataxia.
The changes in the fNIRS measurements and clinical parameters will be analyzed and also the correlation between the two will be analyzed to identify the prognostic value of fNIRS.
- Conditions
- Stroke
- Being tested
- functional near-infrared spectroscopy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional near-infrared spectroscopyDiagnostic test
Functional near-infrared spectroscopy (fNIRS) is a non-invasive method that can evaluate the brain function by measuring the change in brain metabolic activity and hemodynamics during a given task with near-infrared spectroscopy.
| Study group | Role | What they receive |
|---|---|---|
| fNIRS applied | All of the participants' brain activity was evaluated with fNIRS. Receives: Diagnostic Test: functional near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Outcome Prediction Rate
Outcome prediction rate using fNIRS parameter and clinical parameters.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Secondary outcomes (15)
Change of fNIRS activation pattern
The activation pattern was analyzed by nirsLAB software. This software provides data collection and correction function.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Laterality Index
The formula for Laterality Index is (contralateral - ipsilateral)/(contralateral + ipsilateral). The range of Laterality index is -1 to 1. '-1' means all ipsilateral activation and '1' means all contralateral activation.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of National Institutes of Health Stroke Scale (NIHSS) Score
Tool to quantify the impairment from stroke. On a scale from 0 to 42, 0 is one with no stroke symptoms and 42 is a stroke patient with the most severe symptoms. The 11 items of NIHSS are as follows: level of consciousness, horizontal eye movement, visual field test, facial palsy, motor arm, motor leg, limb ataxia, sensory, language, speech, and extinction and inattention.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Glasgow Coma Scale (GCS) Score
A neurological scale to evaluate one's consciousness. There are three elements, which are eye response, verbal response, and motor response. A patient with best response will score 15 and a totally unresponsive patient will score 3.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Modified Barthel Index (MBI) Score
The MBI is a scale that measures activities of daily living. It is composed of 10 categories: fecal incontinence, urinary incontinence, grooming, toilet use, feeding, transfers (e.g., from chair to bed), walking, dressing, climbing stairs, and bathing. A higher score is a patient with better ability to live independently.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Fugl-Meyer Assessment (FMA) Scale
A scale that assess the impairment in a stroke patient. It has three points for each item. When a patient can perform a given task fully, 2 point is given. 1 point is given for partial performance and 0 for not being able to perform the task. The five domains of FMA scale are: motor function (Maximum score in upper limb = 66, Maximum score in lower limb = 34), sensory function (Maximum score = 24), balance (Maximum score = 14), range of motion of joints (Maximum score = 44), and joint pain (Maximum score = 44).
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Brunnstrom Stage Score
Staging of recovery from stroke. The stages are: 1. flaccidity, 2. developing spasticity, 3. pronounced spasticity, 4. spasticity and influence of synergies start to decrease, 5. spasticity declines even more, and 6. no spasticity and near normal stage.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Box and Block Test Score
A test using a box and and blocks to evaluate the upper extremity function.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Grip strength
Used JAMAR Hydraulic Hand Dynamometer and JAMAR Hydraulic Pinch Gauge. Hand grip, pinch grip, lateral prehension, and three jaw chuck were measured.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Modified Ashworth Scale Score
Measurement of spasticity during passive stretching. Wrist flexor/extensor spasticity, elbow flexor/extensor spasticity, and long finger flexor spasticity were measured. On a scale of 0 to 4, 0 means there is no spasticity and 4 means it is rigid in flexion or extension.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Modified Rankin Scale (mRS) Score
A popular validated functional outcome measure in stroke. On a scale from 0 to 6, 0 is one with no symptom and 6 is the worst meaning death.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Functional Ambulatory Category (FAC) Score
On a scale from 1 to 6 ambulation status is described. 1 being the worst and 6 being independent at level and non-level surfaces also.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Neglect Evaluation Battery Score
Includes Motor Free Visual Perception Test (MVPT), Line Bisection Test, Albert Test, Clock Drawing, Comb and Razor, and Catherine Bergego Scale. Used electrical method if available. Otherwise test was performed.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Western Aphasia Battery (WAB)
Measures aphasia type and severity
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Scale for the Assessment and Rating of Ataxia (SARA)
Clinical scale that assess different impairments in cerebellar ataxia. Consisted of 8 items. It is related to gait, stance, sitting, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.
Measured: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start7 Mar 2016
- Primary completion30 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
- Investigators
- Nam-Jong Paik, Ph.D, Principal investigator, Seoul National University Bundang Hospital, Seongnam, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288414
- Sponsor's protocol ID
- B-1601/332-003
- Status last verified
- Jun 2025
- First submitted
- 16 Jul 2019
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value for Predicting Outcome Using Functional Near-infrared Spectroscopy in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT04288414
- Acronym / sponsor ID
- B-1601/332-003
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 28 Feb 2020 (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.
To investigate the prognostic value of Functional Near-Infrared Spectroscopy (fNIRS) in stroke rehabilitation with serial measurements.
Detailed description
Serial measurements (immediately after being transferred to rehabilitation department [T0], at discharge from inpatient rehabilitation [T1], and follow up at one to three months from stroke onset [T3]) using Functional Near-Infrared Spectroscopy (fNIRS) was done in all participants. The primary outcome was the outcome prediction rate using fNIRS parameter and clinical parameters. Secondary outcomes were as follows: fNIRS activation pattern, Laterality Index, Functional Connectivity, Fugl-Meyer Score, Modified Barthel Index, , Brunnstrom Stage, Box and Block Test, Grip Strength (handgrip, pinch grip, lateral prehension, three-jaw chuck), Modified Ashworth Scale (wrist flexor and extensor spasticity, elbow flexor, and extensor spasticity, long finger flexor spasticity), modified Rankin Scale score, Functional Ambulation Category, Glasgow Coma Scale, Neglect Evaluation Battery, Korean Version Western Aphasia Battery, and Scale for the Assessment and Rating of Ataxia.
The changes in the fNIRS measurements and clinical parameters will be analyzed and also the correlation between the two will be analyzed to identify the prognostic value of fNIRS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fNIRS applied | – | Diagnostic Test: functional near-infrared spectroscopyAll of the participants' brain activity was evaluated with fNIRS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients who are receiving rehabilitation.
Key inclusion criteria (5 listed)
- Age 18 or above.
- Diagnosed as stroke (infarction/hemorrhage) with imaging studies.
- Participants who have given consent after listening to the full explanations of this study.
- Able to understand the contents of this study and is able to sign to the written consent by his/herself.
- A legal representative has given written consent for those who meet the inclusion criteria but is unable to understand and agree by themselves due to impaired cognition, a legal representative.
Key exclusion criteria (5 listed)
- Traumatic brain injury.
- Unable to perform simple commands (motor task during fNIRS scan) due to impaired cognition.
- Current symptoms are caused by diseases other than stroke (e.g., dementia, Parkinson's disease)
- Participants with any symptoms that may hinder the compliance or evaluation (e.g., delirium and agitation) process.
- Participants with any uncontrolled disorders.
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 |
|---|---|---|
| functional near-infrared spectroscopyFunctional near-infrared spectroscopy (fNIRS) is a non-invasive method that can evaluate the brain function by measuring the change in brain metabolic activity and hemodynamics during a given task with near-infrared spectroscopy. | Diagnostic test | fNIRS applied |
Primary outcome
Change of Outcome Prediction Rate
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Outcome prediction rate using fNIRS parameter and clinical parameters.
15 secondary outcomes
Change of fNIRS activation pattern
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Laterality Index
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of National Institutes of Health Stroke Scale (NIHSS) Score
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Glasgow Coma Scale (GCS) Score
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Modified Barthel Index (MBI) Score
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Fugl-Meyer Assessment (FMA) Scale
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Brunnstrom Stage Score
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Box and Block Test Score
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Grip strength
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Modified Ashworth Scale Score
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Modified Rankin Scale (mRS) Score
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Functional Ambulatory Category (FAC) Score
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Neglect Evaluation Battery Score
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Western Aphasia Battery (WAB)
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Change of Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Nam-Jong Paik, Ph.D principal investigator
Seoul National University Bundang Hospital, Seongnam, South Korea
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, run by Seoul National University Bundang 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?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 3 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Outcome Prediction Rate (time frame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2025.