Clinical trial NCT04288414: Prognostic Value for Predicting Outcome Using Functional Near-infrared Spectroscopy in Stroke Rehabilitation
Official title: Prognostic Value for Predicting Outcome Using Functional Near-infrared Spectroscopy in Stroke Rehabilitation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients who are receiving rehabilitation.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of Outcome Prediction Rate
timeFrame: 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:
measure: Change of fNIRS activation pattern
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Laterality Index
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of National Institutes of Health Stroke Scale (NIHSS) Score
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Glasgow Coma Scale (GCS) Score
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Modified Barthel Index (MBI) Score
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Fugl-Meyer Assessment (FMA) Scale
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Brunnstrom Stage Score
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Box and Block Test Score
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Grip strength
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Modified Ashworth Scale Score
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Modified Rankin Scale (mRS) Score
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Functional Ambulatory Category (FAC) Score
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Neglect Evaluation Battery Score
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Western Aphasia Battery (WAB)
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
measure: Change of Scale for the Assessment and Rating of Ataxia (SARA)
timeFrame: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
state: Korea, Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital, Seongnam, South Korea
name: Nam-Jong Paik, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: