Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change from Baseline the serum level of Long non-coding ribonucleic acid (lncRNA) at 3 weeks, 3 and 12 months |
LncRNAs are defined as RNA transcripts >200 nucleotides with limited coding potential, but multiple function of binding different DNA, mRNAs and proteins, and they can be expressed under different conditions. As an improvement will be interpreted a significant mean fold change in gene expression (= 2.0, p value = 0.05) between two groups following endogenous gene standardisation and normalization through control adjustment to a value of 1.0. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up at 3 and 12 months. |
|
Primary |
Change from Baseline Patient-reported Outcomes Measurement Information System - Global Health at 3 weeks, 3 and 12 months |
a 10 item scale that assesses an individual's physical, mental, and social health where a standardized score with a mean of 50 and a standard deviation of 10, so a person with a T-score of 40 is one SD below the mean. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up assessments (3 and 12 months after the admission respectively) |
|
Primary |
Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 3 weeks, 3 and 12 months |
the 36-item questionnaire, higher score means higher disability |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively). |
|
Primary |
Change from Baseline Goal Attainment scale at 3 weeks, 3 and 12 months |
Each goal is rated on 5-point scale (-2 much less than expected, 0 achieved the expected level, 2 much more than expected). Higher score means a better outcome. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively). |
|
Secondary |
Change from Baseline Jamar Hydraulic Hand Dynamometer at 3 weeks |
isometric grip force and strength. The higher value, the better function (higher strength) |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline a power of the signal in band from frequency 1 to 2 at 3 weeks |
The spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - a power of the signal in band from f1 to f2 - lower value, lower tremor. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline a frequency for which the smoothed power spectral density is maximal at 3 weeks |
The spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - a frequency for which the smoothed power spectral density is maximal - lower value, lower tremor. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline Nine Hole Peg Test at 3 weeks |
A client takes the pegs from a container, one by one, and places them into the holes on the board, as quickly as possible. Shorter times reflect better function. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline Action Research Arm Test at 3 weeks |
A 19 item observational measure to assess upper extremity performance (coordination, dexterity and functioning). Higher score means better function. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline Motor Activity Log at 3 weeks |
Measure real-world upper extremity function. The MAL adopts a 6-point ordinal scale (0 - 5). Higher score means better function. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline Timed Up And Go at 3 weeks |
The subject stands up from a chair, walks 3m, turns back, and sits down again as quickly and safely as possible while being timed. Higher times reflect worse mobility. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline Berg Balance Scale at 3 weeks |
A 14-task scale that requires subjects to maintain their balance in positions and tasks of increasing difficulty (0 - 56). Higher score means better balance. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline The 10 Metre Walk Test at 3 weeks |
A performance measure used to assess walking speed in meters per second over 10 meters. Shorter times reflect better mobility. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline The 6 Minute Walk Test at 3 weeks |
A long walking capacity test recording the maximal distance a subject walks at the fastest speed possible in 6 minutes. The more distance covered, the better the walking performance is. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline Functional Independence Measure at 3 weeks |
An 18-item measurement tool that explores an individual's physical, psychological and social function. Higher score is better (higher independence). |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline The Gugging Swallowing Screen at 3 weeks |
It assesses the severity of aspiration risk (0 - 20). Higher score means better function. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline The 3F Test - Dysarthric Profile at 3 weeks |
The overall Index of Dysarthria (ID) is a sum of 45 items with the maximum score of 90 (the best function). This examination will be recorded and analysed by the beta version of the freely available Dysarthria Analyzer (Czech Technical University in Prague, available at http://dysan.cz/) |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline The Mississippi Aphasia Screening Test at 3 weeks |
A brief, repeatable screening measure for individuals with severely impaired communication/language skills. The sum of subtests 1-3 and 8-9 scores forms the MAST-E (range 0-50), while the subtests 4-7 form the MAST-R (range 0-50), and the sum of all subtests forms the MAST-T (range 0-100). Higher score, better function. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline Image Naming Test at 3 weeks |
a test of confrontational naming of nouns and verbs. Words are selected based on success, frequency of occurrence, age of adoption, length, and visual complexity. The maximum sum is 60 points (30 verbs and 30 nouns), the results can be assessed qualitatively according to the type of unexplained words (0 - 60). Higher score means better function. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline Amnesia Light and Brief Assessment at 3 weeks |
the original Czech and innovative test of how to easily (therefore in the name Light) and quickly examine the state of memory (therefore Amnesia Assessment) within two to three minutes (therefore Brief). The sum, called ALBA score, is derived from correctly recalled words of the sentence and correctly recalled gestures together (W2 + G2: 0-12). Higher score means better function. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline Naming Pictures and Their Equipment at 3 weeks |
an original Czech and short test, the purpose of which is to quickly check simultaneously written speech, long-term semantic and short-term visual memory. The title describes the main content of testing and the abbreviation POBAV (Naming Pictures and Their Equipment) was created from the key letters. The task of the examinee is to write the names of 20 pictures in one word and at the same time remember them. Participant is then asked to rewrite the names of the pictures he remembers (0 - 20). Higher score means better function. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline Neuro - Quality of Life depression at 3 weeks |
a self-report of health-related quality of life in domain concerning depression, The T-score rescales the raw sum score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean, while a person who has T-score of 60 is one standard deviation better (healthier) than the general population. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|
Secondary |
Change from Baseline The Montreal Cognitive Assessment at 3 weeks |
an assesment for detecting cognitive impairment ranged between 0 and 30 points. The more the better. |
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks) |
|