The goal of this clinical trial is to learn if a music-based telerehabilitation intervention implemented at home works to treat different kinds of neurological deficits caused by stroke. The main questions it aims to answer are: 1) Can the music intervention improve recovery of cognitive, verbal, motor, and emotional deficits after stroke, 2) can the music intervention enhance structural and functional recovery of the brain, and (3) how different demographic, musical, and clinical background factors affect the way the music intervention works. Researchers will compare the music intervention to standard (usual) care to see if the music intervention works to treat the deficits caused by stroke. Subjects are stroke patients who will participate either in the music intervention 5 times/week for 10 weeks in addition to standard care or receive standard care only. During the trial, the subjects will undergo neuropsychological testing and magnetic resonance imaging (MRI) three times: at baseline (before the intervention), at 3-month stage (immediately after the intervention), and at 6-month stage (3 months after the intervention).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
The music-based telerehabilitation program is a 10-week multicomponent intervention which includes (1) rhythm-based training of motor and cognitive (attention, working memory, executive function) functions, (2) singing-based training of speech production (using singing and melodic intonation therapy training), (3) playing-based training of upper-extremity motor functions (using instrumental training with a xylophone), and (4) music listening for enhancement of mood, attention, and memory. Training is done using a tablet computer and an online platform comprising a collection of short (3-5 min) training videos for each of the 4 training modules, which the patients are instructed to train with at home for 4 days / week (60 min/day). Additionally, the patients participate in a remote (online) music therapy session led by a music therapist for 1 day/week (60 min).
University of Helsinki / Faculty of Medicine / Department of Psychology
Helsinki, Finland
RECRUITINGChange in the cognitive functioning summary score from baseline to 3-month stage
Cognitive functioning summary score is calculated as an average of rescaled scores in following tests: Montreal Cognitive Assessment (MoCA) total score, MoCA Verbal Fluency subtest total score, Sustained Attention to Response Task (SART; correct responses \& reaction times), Flexible Attention Test (FAT) / Reaction Time subtest (reaction times) and Trail Making subtest (correct responses \& reaction times from difference scores between B part and A part), Simon Task (correct responses \& reaction times from difference scores between Incongruence part and Congruence part), and Wechsler Memory Scale III (WMS-III) / Digit Span subtest (total score) and Spatial Span subtest (total score). Raw scores are rescaled to a scale of 0-100 using min-max normalization \[(x-min(x))/(max(x)-min(x))\*100\] across the measurement points. The range of the summary score is 0-100 (higher score indicates better outcome).
Time frame: Baseline and 3-month stage
Change in the speech production summary score from baseline to 3-month stage
Speech production summary score is calculated as an average of percentage of correct responses (score/maximum value\*100; range 0-100) in the following subtests of the Western Aphasia Battery (WAB): Conversational Question, Picture Description, Repetition, Object Naming, Word Fluency, Sentence Completion, and Responsive Speech. The range of the summary score is 0-100 (higher score indicates better outcome).
Time frame: Baseline and 3-month stage
Change in the upper-extremity motor function summary score from baseline to 3-month stage
Upper-extremity motor function summary score is calculated as an average of percentage of correct responses (score/maximum value\*100; range 0-100) in following tests: Action Research Arm Test (ARAT; total score), Box and Block Test (BBT; total score), and Purdue Pegboard Test (PPT; total score). The range of the summary score is 0-100 (higher score indicates better outcome).
Time frame: Baseline and 3-month stage
Change in the mood and quality of life summary score from baseline to 3-month stage
Mood and quality of life summary score is calculated as an average of percentage scores (score/maximum value\*100; range 0-100) in following self-report questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS) / Depression scale (total score), PROMIS / Anxiety scale (total score), and Stroke Impact Scale (SIS; total score). The scores of the PROMIS are reversed to align with the SIS scores. The range of the summary score is 0-100 (higher score indicates better outcome).
Time frame: Baseline and 3-month stage
Change in the cognitive functioning summary score from baseline to 6-month stage
Cognitive functioning summary score is calculated as an average of rescaled scores in following tests: Montreal Cognitive Assessment (MoCA) total score, MoCA Verbal Fluency subtest total score, Sustained Attention to Response Task (SART; correct responses \& reaction times), Flexible Attention Test (FAT) / Reaction Time subtest (reaction times) and Trail Making subtest (correct responses \& reaction times from difference scores between B part and A part), Simon Task (correct responses \& reaction times from difference scores between Incongruence part and Congruence part), and Wechsler Memory Scale III (WMS-III) / Digit Span subtest (total score) and Spatial Span subtest (total score). Raw scores are rescaled to a scale of 0-100 using min-max normalization \[(x-min(x))/(max(x)-min(x))\*100\] across the measurement points. The range of the summary score is 0-100 (higher score indicates better outcome).
Time frame: Baseline and 6-month stage
Change in the speech production summary score from baseline to 6-month stage
Speech production summary score is calculated as an average of percentage of correct responses (score/maximum value\*100; range 0-100) in the following subtests of the Western Aphasia Battery (WAB): Conversational Question, Picture Description, Repetition, Object Naming, Word Fluency, Sentence Completion, and Responsive Speech. The range of the summary score is 0-100 (higher score indicates better outcome).
Time frame: Baseline and 6-month stage
Change in the upper-extremity motor function summary score from baseline to 6-month stage
Upper-extremity motor function summary score is calculated as an average of percentage of correct responses (score/maximum value\*100; range 0-100) in following tests: Action Research Arm Test (ARAT; total score), Box and Block Test (BBT; total score), and Purdue Pegboard Test (PPT; total score). The range of the summary score is 0-100 (higher score indicates better outcome).
Time frame: Baseline and 6-month stage
Change in the mood and quality of life summary score from baseline to 6-month stage
Mood and quality of life summary score is calculated as an average of percentage scores (score/maximum value\*100; range 0-100) in following self-report questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS) / Depression scale (total score), PROMIS / Anxiety scale (total score), and Stroke Impact Scale (SIS; total score). The scores of the PROMIS are reversed to align with the SIS scores. The range of the summary score is 0-100 (higher score indicates better outcome).
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Time frame: Baseline and 6-month stage
Change in the attention summary score from baseline to 3-month and 6-month stages
Attention summary score is calculated as an average of rescaled scores in following tests: Sustained Attention to Response Task (SART; correct responses \& reaction times), Flexible Attention Test (FAT) / Reaction Time subtest (reaction times) and Trail Making subtest (correct responses \& reaction times from A part), and Simon Task (correct responses \& reaction times from Congruence part). Raw scores are rescaled to a scale of 0-100 using min-max normalization \[(x-min(x))/(max(x)-min(x))\*100\] across the measurement points. The range of the summary score is 0-100 (higher score indicates better outcome).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the executive function summary score from baseline to 3-month and 6-month stages
Executive function summary score is calculated as an average of rescaled scores in following tests: MoCA Verbal Fluency subtest total score, Flexible Attention Test (FAT) / Trail Making subtest (correct responses \& reaction times from difference scores between B part and A part), and Simon Task (correct responses \& reaction times from difference scores between Incongruence part and Congruence part). Raw scores are rescaled to a scale of 0-100 using min-max normalization \[(x-min(x))/(max(x)-min(x))\*100\] across the measurement points. The range of the summary score is 0-100 (higher score indicates better outcome).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the working memory summary score from baseline to 3-month and 6-month stages
Working memory summary score is calculated as an average of percentage of correct responses (score/maximum value\*100; range 0-100) in the Wechsler Memory Scale III (WMS-III) / Digit Span subtest (total score) and Spatial Span subtest (total score). The range of the summary score is 0-100 (higher score indicates better outcome).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the MoCA total score from baseline to 3-month and 6-month stages
Montreal Cognitive Assessment (MoCA) total score (range 0-30, higher score indicates better outcome), measures general cognitive function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the MoCA Verbal Fluency subtest score from baseline to 3-month and 6-month stages
Montreal Cognitive Assessment (MoCA) Verbal Fluency subtest score (phonemic fluency; min value: 0, max value: no upper limit; higher score indicates better outcome), measures executive functioning (cognitive flexibility).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the SART correct responses from baseline to 3-month and 6-month stages
Sustained Attention to Response Task (SART), number of correct responses (range 0-225, higher score indicates better outcome), measures sustained attention.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the SART reaction times from baseline to 3-month and 6-month stages
Sustained Attention to Response Task (SART), average reaction time (ms) across trials (scores do not have a fixed range, lower score indicates better outcome), measures sustained attention.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the FAT Reaction Time subtest reaction times from baseline to 3-month and 6-month stages
Flexible Attention Test (FAT) / Reaction Time subtest, average reaction time (ms) across trials (scores do not have a fixed range, lower score indicates better outcome), measures selective attention \& psychomotor speed.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the FAT Trail Making subtest (A part) correct responses from baseline to 3-month and 6-month stages
Flexible Attention Test (FAT) / Trail Making subtest (A part), number of correct responses (range 0-24, higher score indicates better outcome), measures selective attention.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the FAT Trail Making subtest (A part) reaction times from baseline to 3-month and 6-month stages
Flexible Attention Test (FAT) / Trail Making subtest (A part), average reaction time (ms) across trials (scores do not have a fixed range, lower score indicates better outcome), measures selective attention.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the FAT Trail Making subtest (B part) correct responses from baseline to 3-month and 6-month stages
Flexible Attention Test (FAT) / Trail Making subtest (B part), number of correct responses (range 0-24, higher score indicates better outcome), measures executive function (set-shifting).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the FAT Trail Making subtest (B part) reaction times from baseline to 3-month and 6-month stages
Flexible Attention Test (FAT) / Trail Making subtest (B part), average reaction time (ms) across trials (scores do not have a fixed range, lower score indicates better outcome), measures executive function (set-shifting).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the FAT Trail Making subtest (difference between B part and A part) correct responses from baseline to 3-month and 6-month stages
Flexible Attention Test (FAT) / Trail Making subtest (difference between B part and A part), number of correct responses (range 0-24, lower score indicates better outcome), measures executive function (set-shifting).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the FAT Trail Making subtest (difference between B part and A part) reaction times from baseline to 3-month and 6-month stages
Flexible Attention Test (FAT) / Trail Making subtest (difference between B part and A part), average reaction time (ms) across trials (scores do not have a fixed range, lower score indicates better outcome), measures executive function (set-shifting).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the Simon Task (Congruence part) correct responses from baseline to 3-month and 6-month stages
Simon Task / Congruence part, number of correct responses (range 0-50, higher score indicates better outcome), measures selective attention.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the Simon Task (Congruence part) reaction times from baseline to 3-month and 6-month stages
Simon Task / Congruence part, average reaction time (ms) across trials (scores do not have a fixed range, lower score indicates better outcome), measures selective attention.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the Simon Task (Incongruence part) correct responses from baseline to 3-month and 6-month stages
Simon Task / Incongruence part, number of correct responses (range 0-50, higher score indicates better outcome), measures executive function (inhibition).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the Simon Task (Incongruence part) reaction times from baseline to 3-month and 6-month stages
Simon Task / Incongruence part, average reaction time (ms) across trials (scores do not have a fixed range, lower score indicates better outcome), measures executive function (inhibition).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the Simon Task (difference between Incongruence part and Congruence part) correct responses from baseline to 3-month and 6-month stages
Simon Task: Difference between Incongruence part and Congruence part, number of correct responses (range 0-50, lower score indicates better outcome), measures executive function (set-shifting).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the Simon Task (difference between Incongruence part and Congruence part) reaction times from baseline to 3-month and 6-month stages
Simon Task: Difference between Incongruence part and Congruence part, average reaction time (ms) across trials (scores do not have a fixed range, lower score indicates better outcome), measures executive function (set-shifting).
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Digit Span subtest (forward recall score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Digit Span subtest, forward recall score (range 0-16, higher score indicates better outcome), measures verbal working memory.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Digit Span subtest (backward recall score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Digit Span subtest, backward recall score (range 0-14, higher score indicates better outcome), measures verbal working memory.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Digit Span subtest (total score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Digit Span subtest, total score (range 0-30, higher score indicates better outcome), measures verbal working memory.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Spatial Span subtest (forward recall score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Spatial Span subtest, forward recall score (range 0-16, higher score indicates better outcome), measures visuospatial working memory.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Spatial Span subtest (backward recall score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Spatial Span subtest, backward recall score (range 0-16, higher score indicates better outcome), measures visuospatial working memory.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Spatial Span subtest (total score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Spatial Span subtest, total score (range 0-32, higher score indicates better outcome), measures visuospatial working memory.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Word Lists subtest (1st learning trial score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Word Lists subtest, 1st learning trial score (range 0-12, higher score indicates better outcome), measures verbal memory \& learning
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Word Lists subtest (learning trials change score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Word Lists subtest, change score from the 1st to 4th learning trial (range 0-12, higher score indicates better outcome), measures verbal memory \& learning.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Word Lists subtest (learning trials total score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Word Lists subtest, total score over 4 learning trials (range 0-48, higher score indicates better outcome), measures verbal memory \& learning.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Word Lists subtest (learning trials recognition score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Word Lists subtest, recognition (old-new) score after 4 learning trials (range 0-24, higher score indicates better outcome), measures verbal memory \& learning.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Word Lists subtest (delayed recall score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Word Lists subtest, delayed recall score (range 0-12, higher score indicates better outcome), measures verbal memory \& learning.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WMS-III Word Lists subtest (delayed recognition score) from baseline to 3-month and 6-month stages
Wechsler Memory Scale III (WMS-III) / Word Lists subtest, recognition (old-new) score after delay (range 0-24, higher score indicates better outcome), measures verbal memory \& learning.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the RBMT Story Recall subtest (immediate recall score) from baseline to 3-month and 6-month stages
Rivermead Behavioural Memory Test (RBMT) / Story Recall subtest, immediate recall score (range 0-42, higher score indicates better outcome), measures episodic memory
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the RBMT Story Recall subtest (immediate recognition score) from baseline to 3-month and 6-month stages
Rivermead Behavioural Memory Test (RBMT) / Story Recall subtest, recognition (old-new) score after immediate recall (range 0-12, higher score indicates better outcome), measures episodic memory.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the RBMT Story Recall subtest (delayed recall score) from baseline to 3-month and 6-month stages
Rivermead Behavioural Memory Test (RBMT) / Story Recall subtest, delayed recall score (range 0-42, higher score indicates better outcome), measures episodic memory.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the RBMT Story Recall subtest (delayed recognition score) from baseline to 3-month and 6-month stages
Rivermead Behavioural Memory Test (RBMT) / Story Recall subtest, recognition (old-new) score after delay (range 0-12, higher score indicates better outcome), measures episodic memory.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the BIT Star Cancellation subtest (left side score) from baseline to 3-month and 6-month stages
Behavioral Inattention Test (BIT) / Star Cancellation subtest, number of correctly marked items on the left side (range 0-27, higher score indicates better outcome), measures spatial attention (unilateral spatial neglect)
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the BIT Star Cancellation subtest (right side score) from baseline to 3-month and 6-month stages
Behavioral Inattention Test (BIT) / Star Cancellation subtest, number of correctly marked items on the right side (range 0-27, higher score indicates better outcome), measures spatial attention (unilateral spatial neglect)
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the BIT Star Cancellation subtest (laterality index) from baseline to 3-month and 6-month stages
Behavioral Inattention Test (BIT) / Star Cancellation subtest, ratio of correctly marked items on the left side to total correctly marked items (range 0-1, lower score indicates better outcome), measures spatial attention (unilateral spatial neglect)
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the BIT Star Cancellation subtest (total score) from baseline to 3-month and 6-month stages
Behavioral Inattention Test (BIT) / Star Cancellation subtest, number of correctly marked items (range 0-54, higher score indicates better outcome), measures spatial attention (unilateral spatial neglect)
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Conversational Question subtest score from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Conversational Question subtest, score (range 0-6, higher score indicates better outcome), measures spontaneous speech production.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Conversational Question & Picture Description subtests (information content score) from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Conversational Question \& Picture Description subtests, information content score (range 0-10, higher score indicates better outcome), measures spontaneous speech production
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Conversational Question & Picture Description subtests (fluency of speech score) from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Conversational Question \& Picture Description subtests, fluency of speech score (range 0-10, higher score indicates better outcome), measures spontaneous speech production.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Spontaneous speech score from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Spontaneous speech score (sum of information content and fluency of speech scores; range 0-20, higher score indicates better outcome), measures spontaneous speech production.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Conversational Question & Picture Description subtests (efficiency score) from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Conversational Question \& Picture Description subtests, number of correct information units per minute (min: 0, max: no fixed value, higher score indicates better outcome), measures spontaneous speech production.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Repetition subtest score from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Repetition subtest, score (range: 0-100, higher score indicates better outcome), measures responsive speech production.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Object Naming subtest score from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Object Naming subtest, score (range: 0-60, higher score indicates better outcome), measures responsive speech production.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Word Fluency subtest score from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Word Fluency subtest, score (range: 0-20, higher score indicates better outcome), measures responsive speech production.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Sentence Completion subtest score from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Sentence Completion subtest, score (range: 0-10, higher score indicates better outcome), measures responsive speech production.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Responsive Speech subtest score from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Responsive Speech subtest, score (range: 0-10, higher score indicates better outcome), measures responsive speech production.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Naming and Word Finding score from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Naming and Word Finding score (sum of Object Naming, Word Fluency, Sentence Completion, Responsive Speech subtest scores; range: 0-100, higher score indicates better outcome), measures responsive speech production.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the WAB Sequential Commands subtest score from baseline to 3-month and 6-month stages
Western Aphasia Battery (WAB) / Sequential Commands subtest, score (range: 0-80, higher score indicates better outcome), measures verbal comprehension.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the BDAE Verbal Agility subtest score from baseline to 3-month and 6-month stages
Boston Diagnostic Aphasia Examination (BDAE) / Verbal Agility subtest, score (range: 0-14, higher score indicates better outcome), measures motor production of speech
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the BDAE Automatized Sequences subtest score from baseline to 3-month and 6-month stages
Boston Diagnostic Aphasia Examination (BDAE) / Automatized Sequences subtest, score (range: 0-8, higher score indicates better outcome), measures non-propositional speech.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT Grasp subscale score (paretic hand) from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) / Grasp subscale score of the paretic hand (range: 0-18, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT Grasp subscale score (non-paretic hand) from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) / Grasp subscale score of the non-paretic hand (range: 0-18, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT Grip subscale score (paretic hand) from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) / Grip subscale score of the paretic hand (range: 0-12, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT Grip subscale score (non-paretic hand) from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) / Grip subscale score of the non-paretic hand (range: 0-12, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT Pinch subscale score (paretic hand) from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) / Pinch subscale score of the paretic hand (range: 0-18, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT Pinch subscale score (non-paretic hand) from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) / Pinch subscale score of the non-paretic hand (range: 0-18, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT Gross Movement subscale score (paretic hand) from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) / Gross Movement subscale score of the paretic hand (range: 0-9, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT Gross Movement subscale score (non-paretic hand) from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) / Gross Movement subscale score of the non-paretic hand (range: 0-9, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT total score (paretic hand) from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) total score of the paretic hand (range: 0-57, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT total score (non-paretic hand) from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) total score of the non-paretic hand (range: 0-57, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the ARAT total score from baseline to 3-month and 6-month stages
Action Research Arm Test (ARAT) total score (both paretic \& non-paretic hands; range: 0-114, higher score indicates better outcome), measures upper-extremity motor function.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the BBT paretic hand score from baseline to 3-month and 6-month stages
Box and Block Test (BBT) total score for the paretic hand (range: 0-150, higher score indicates better outcome), measures gross manual dexterity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the BBT non-paretic hand score from baseline to 3-month and 6-month stages
Box and Block Test (BBT) total score for the non-paretic hand (range: 0-150, higher score indicates better outcome), measures gross manual dexterity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the BBT total score from baseline to 3-month and 6-month stages
Box and Block Test (BBT) total score for both hands (range: 0-300, higher score indicates better outcome), measures gross manual dexterity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the PPT paretic hand score from baseline to 3-month and 6-month stages
Purdue Pegboard Test (PPT) score of the paretic hand (range: 0-25, higher score indicates better outcome), measures fine manual dexterity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the PPT non-paretic hand score from baseline to 3-month and 6-month stages
Purdue Pegboard Test (PPT) score of the non-paretic hand (range: 0-25, higher score indicates better outcome), measures fine manual dexterity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the PPT both hands score from baseline to 3-month and 6-month stages
Purdue Pegboard Test (PPT) score of both hands (range: 0-25, higher score indicates better outcome), measures fine manual dexterity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the PPT total score from baseline to 3-month and 6-month stages
Purdue Pegboard Test (PPT) total score (range: 0-75, higher score indicates better outcome), measures fine manual dexterity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in the PPT Assembly score from baseline to 3-month and 6-month stages
Purdue Pegboard Test (PPT) Assembly score (range: 0-80, higher score indicates better outcome), measures fine manual dexterity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in PROMIS Depression subscale total score from baseline to 3-month and 6-month stages
Patient-Reported Outcomes Measurement Information System (PROMIS) / Depression subscale total score (patient self-report; range: 5-40, lower score indicates better outcome), measures depression.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in PROMIS Anxiety subscale total score from baseline to 3-month and 6-month stages
Patient-Reported Outcomes Measurement Information System (PROMIS) / Anxiety subscale total score (patient self-report; range: 5-40, lower score indicates better outcome), measures anxiety.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Strength subscale score (patient self-report) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Strength subscale score (patient self-report; range: 0-100, higher score indicates better outcome), measures strength of the paretic upper-extremity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Hand Function subscale score (patient self-report) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Hand Function subscale score (patient self-report; range: 0-100, higher score indicates better outcome), measures hand function of the paretic upper-extremity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS ADL subscale score (patient self-report) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / ADL subscale score (patient self-report; range: 0-100, higher score indicates better outcome), measures ability to perform activities of daily living.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Mobility subscale score (patient self-report) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Mobility subscale score (patient self-report; range: 0-100, higher score indicates better outcome), measures mobility in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Communication subscale score (patient self-report) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Communication subscale score (patient self-report; range: 0-100, higher score indicates better outcome), measures communication ability in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Emotion subscale score (patient self-report) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Emotion subscale score (patient self-report; range: 0-100, higher score indicates better outcome), measures mood.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Memory and Thinking subscale score (patient self-report) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Memory and Thinking subscale score (patient self-report; range: 0-100, higher score indicates better outcome), measures cognitive functioning in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Participation subscale score (patient self-report) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Participation subscale score (patient self-report; range: 0-100, higher score indicates better outcome), measures social interaction and involvement in life situations.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Recovery item score (patient self-report) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Recovery item score (patient self-report using visual analogue scale, range: 0-100, higher score indicates better outcome), measures patient's perception of their overall recovery from stroke.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS total score (patient self-report) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) total score (patient self-report; range: 0-900, higher score indicates better outcome), measures overall quality of life after stroke.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Strength subscale score (proxy report of family member) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Strength subscale score (proxy report of family member; range: 0-100, higher score indicates better outcome), measures strength of the paretic upper-extremity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Hand Function subscale score (proxy report of family member) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Hand Function subscale score (proxy report of family member; range: 0-100, higher score indicates better outcome), measures hand function of the paretic upper-extremity.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS ADL subscale score (proxy report of family member) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / ADL subscale score (proxy report of family member; range: 0-100, higher score indicates better outcome), measures ability to perform activities of daily living.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Mobility subscale score (proxy report of family member) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Mobility subscale score (proxy report of family member; range: 0-100, higher score indicates better outcome), measures mobility in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Communication subscale score (proxy report of family member) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Communication subscale score (proxy report of family member; range: 0-100, higher score indicates better outcome), measures communication ability in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Emotion subscale score (proxy report of family member) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Emotion subscale score (proxy report of family member; range: 0-100, higher score indicates better outcome), measures mood.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Memory and Thinking subscale score (proxy report of family member) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Memory and Thinking subscale score (proxy report of family member; range: 0-100, higher score indicates better outcome), measures cognitive functioning in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Participation subscale score (proxy report of family member) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Participation subscale score (proxy report of family member; range: 0-100, higher score indicates better outcome), measures social interaction and involvement in life situations.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS Recovery item score (proxy report of family member) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) / Recovery item score (proxy report of family member using visual analogue scale, range: 0-100, higher score indicates better outcome), measures family member's perception of patient's overall recovery from stroke.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in SIS total score (proxy report of family member) from baseline to 3-month and 6-month stages
Stroke Impact Scale (SIS) total score (proxy report of family member; range: 0-900, higher score indicates better outcome), measures overall quality of life after stroke.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in MAL total score (patient self-report) from baseline to 3-month and 6-month stages
Motor Activity Log (MAL) total score (patient self-report; range: 0-70, higher score indicates better outcome), measures severity of upper-extremity paresis.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in MAL total score (proxy report of family member) from baseline to 3-month and 6-month stages
Motor Activity Log (MAL) total score (proxy report of family member; range: 0-70, higher score indicates better outcome), measures severity of upper-extremity paresis.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in CAL Quantity of Communication scale score (patient self-report) from baseline to 3-month and 6-month stages
Communicative Activity Log (CAL) / Quantity of Communication score (patient self-report; range: 0-90, higher score indicates better outcome), measures quantity of communication in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in CAL Quality of Communication score (patient self-report) from baseline to 3-month and 6-month stages
Communicative Activity Log (CAL) / Quality of Communication scale score (patient self-report; range: 0-90, higher score indicates better outcome), measures quality of communication in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in CAL total score (patient self-report) from baseline to 3-month and 6-month stages
Communicative Activity Log (CAL) total score (patient self-report; range: 0-180, higher score indicates better outcome), measures communication ability in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in CAL Quantity of Communication scale score (proxy report of family member) from baseline to 3-month and 6-month stages
Communicative Activity Log (CAL) / Quantity of Communication score (proxy report of family member; range: 0-90, higher score indicates better outcome), measures quantity of communication in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in CAL Quality of Communication score (proxy report of family member) from baseline to 3-month and 6-month stages
Communicative Activity Log (CAL) / Quality of Communication scale score (proxy report of family member; range: 0-90, higher score indicates better outcome), measures quality of communication in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in CAL total score (proxy report of family member) from baseline to 3-month and 6-month stages
Communicative Activity Log (CAL) total score (proxy report of family member; range: 0-180, higher score indicates better outcome), measures communication ability in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in CFQ total score (patient self-report) from baseline to 3-month and 6-month stages
Cognitive Failures Questionnaire (CFQ) total score (patient self-report; range: 0-100, lower score indicates better outcome), measures severity of attention and executive deficits in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage
Change in PRMQ total score (patient self-report) from baseline to 3-month and 6-month stages
Prospective and Retrospective Memory Questionnaire (PRMQ) total score (patient self-report; range: 5-80, higher score indicates better outcome), measures memory functioning in daily life.
Time frame: Baseline, 3-month stage, and 6-month stage