Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change of Fugl Meyer Assessment-Upper Limb (FMA-UL) Score |
Impairment measurement |
Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3). |
|
Secondary |
Change of Finger Tapping Test Score (taps/minute) |
The number of finger tapping on I-pad screen per 10 seconds for 1 session. Total : 3 sessions |
Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3). |
|
Secondary |
Change of Finger Extension (Metarcapophalangeal [MCP] joint) Range of Motion (degree) |
Range of motion of 2nd finger is measured with Goniometer. |
Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3). |
|
Secondary |
Change of Hand grasp power (lb) |
Measured with Dynamometer |
Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3). |
|
Secondary |
Change of Brunnstrom Stage |
Observational evaluation of the stage of recovery of a stroke patient. There are six stages (1: flaccid, 2: spasticity appears, 3: pronounced spasticity, 4: start of deviation from spasticity, 5: spasticity decreased more than 4 and complex movement combinations are possible, 6: No more spasticity present, near normal to normal movement |
Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3). |
|
Secondary |
Change of muscle strength (Medical Research Council)-Upper extremity |
Manual measurement of muscle strength. Range from 0 to 5. When there is absolute no movement of muscle it scored as 0. When muscle activation is felt by palpation but no movement is present it is scored as 1. If full range of motion is possible with gravity removed it is scored as 2. If one can move his/her joint to full range of motion against gravity but without other resistance it is scored as 3. If one can resist mild resistance it is score as 4. If one's muscle strength is normal it is scored as 5. |
Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3). |
|
Secondary |
Change of Box and Block Test (BBT) Score (boxes/60 second) |
An observational measurement on manual dexterity. The observer counts the number of boxes that participant can move across the mid-line dissection board in a limited time (60 seconds). |
Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3). |
|
Secondary |
Change of Functional near-infrared spectroscopy Connectivity |
Near infrared spectroscopy is a tool that can measure the brain activity and subsequently analyze connectivity between each recording spot. The connectivity will be reported as an illustration or image |
Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3). |
|
Secondary |
Change of Modified Ashworth Scale (MAS) of upper extremity |
Measures resistance during passive muscle stretching and is used as a simple measure of spasticity. 0: No increase in muscle tone, 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension. 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3: Considerable increase in muscle tone, passive movement difficult. 4: Affected part(s) rigid in flexion or extension. |
Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3). |
|
Secondary |
Change of range of motion of finger extension (degrees) measured with Camera and marker |
Markers (stickers) are placed on finger joints (Proximal phalangeal joint, Distal phalangeal joint) and finger tip of the 2nd finger. The camera will recognize the marker and measure the range of 2nd finger extension. |
Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3). |
|