Prognostic Value for Predicting Outcome Using Functional Near-infrared Spectroscopy in Stroke Rehabilitation
Keywords
Abstract
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.
Dates
Last Verified: | 01/31/2020 |
First Submitted: | 07/15/2019 |
Estimated Enrollment Submitted: | 02/24/2020 |
First Posted: | 02/27/2020 |
Last Update Submitted: | 02/24/2020 |
Last Update Posted: | 02/27/2020 |
Actual Study Start Date: | 03/06/2016 |
Estimated Primary Completion Date: | 02/28/2022 |
Estimated Study Completion Date: | 02/28/2022 |
Condition or disease
Intervention/treatment
Diagnostic Test: fNIRS applied
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
fNIRS applied All of the participants' brain activity was evaluated with fNIRS. | Diagnostic Test: fNIRS applied 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. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Sampling method | Non-Probability Sample |
Accepts Healthy Volunteers | Yes |
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. |
Outcome
Primary Outcome Measures
1. Change of Outcome Prediction Rate [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 Outcome Measures
1. Change of fNIRS activation pattern [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
2. Change of Laterality Index [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
3. Change of National Institutes of Health Stroke Scale (NIHSS) Score [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
4. Change of Glasgow Coma Scale (GCS) Score [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
5. Change of Modified Barthel Index (MBI) Score [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
6. Fugl-Meyer Assessment (FMA) Scale [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
7. Change of Brunnstrom Stage Score [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
8. Change of Box and Block Test Score [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
9. Change of Grip strength [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
10. Change of Modified Ashworth Scale Score [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
11. Change of Modified Rankin Scale (mRS) Score [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
12. Change of Functional Ambulatory Category (FAC) Score [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
13. Change of Neglect Evaluation Battery Score [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
14. Change of Western Aphasia Battery (WAB) [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]
15. Change of Scale for the Assessment and Rating of Ataxia (SARA) [After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)]