Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Communication ability |
Total score of the Communication Action Log (CAL) questionnaire (range 0-180, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Primary |
Spontaneous speech production |
Spontaneous Speech subscale score of the Western Aphasia Battery (WAB) (range 0-20, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Primary |
Connected speech informativeness |
Percentage of correct information units (CIUs) produced in a picture description task |
Change from baseline at 5 months and 9 months |
|
Primary |
Repetition of words and sentences |
Repetition subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Primary |
Verbal agility |
Verbal Agility subtest score of the Boston Diagnostic Aphasia Examinaton (BDAE) (range 0-14, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Primary |
Naming and word finding |
Naming and Word Finding subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Primary |
Verbal comprehension |
Sequential Commands subtest score of the Western Aphasia Battery (WAB) (range 0-80, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Executive function (correct responses) |
Simon Task: score (range 0-100, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Executive function (reaction times) |
Simon Task: reaction time mean (ms) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Attention (correct responses) |
Flexible Attention Test (FAT): score (range 0-48, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Attention (reaction times) |
Flexible Attention Test (FAT): reaction time mean (ms) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Working memory |
Word Span subtest score of the Kielelliset Arviointitehtävät (KAT) (range 0-30, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Verbal memory |
Logical Memory subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-80, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Verbal learning |
Word Lists subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-84, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Singing ability |
Acoustic features (e.g., pitch, rhythm, intensity) analyzed from recorded production of familiar and novel songs using acoustic analysis software |
Change from baseline at 5 months and 9 months |
|
Secondary |
Music perception |
Montreal Battery of Evaluation of Amusia (MBEA) score (range 0-30, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Functional stroke recovery |
Total score of the Stroke Impact Scale (SIS) questionnaire (range 0-900, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Depression |
Total score of the Center for Epidemiological Studies Depression Scale (CES-D) questionnaire (range 0-60, lower score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Mood |
Total score of the Visual Analog Mood Scales (VAMS) questionnaire (range 0-800, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Social interaction |
Total score of the Social Provision Scale (SPS) questionnaire (range 24-96, higher score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Caregiver burden |
Total score of the Zarit Burden Interview (ZBI-22) questionnaire (range 0-88, lower score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Psychological stress of the caregiver |
Total score of the General Health Questionnaire (GHQ-12) (range 0-36, lower score indicates better outcome) |
Change from baseline at 5 months and 9 months |
|
Secondary |
Electroencephalography (EEG) |
Amplitude and latency of event-related potentials (ERPs) associated with learning and memory in two auditory tasks |
Change from baseline at 5 months and 9 months |
|
Secondary |
Structural magnetic resonance imaging (sMRI): MPRAGE sequence |
Grey matter volume in frontotemporal, frontoparietal, and limbic brain regions |
Change from baseline at 5 months and 9 months |
|
Secondary |
Structural magnetic resonance imaging (sMRI): DTI sequence |
Structural connectivity of intra- and interhemispheric white matter tracts |
Change from baseline at 5 months and 9 months |
|
Secondary |
Functional magnetic resonance imaging (fMRI): resting-state |
resting-state fMRI sequence: functional connectivity of frontotemporal, frontoparietal, and limbic brain networks |
Change from baseline at 5 months and 9 months |
|
Secondary |
Functional magnetic resonance imaging (fMRI): singing-related activity |
task-based fMRI sequence: frontotemporal, frontoparietal, and limbic activation patterns associated with the perception, vocal repetition, and recall of novel songs |
Change from baseline at 5 months and 9 months |
|