Trial · NCT06291480
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Motivation: Brain Injury Rehabilitation Trust Motivation Questionnaire (BMQ-S) [self-reported] | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | The BMQ-S is a 34-item questionnaire, which measures the motivation levels of the stroke survivor, using a 4-point likert scale (always, often, sometimes, never). Items that involve different factors such as anhedonia, perseveration, poor initiation, or distractibility, are summed to create a total score from 34 to 136, with higher scores representing greater difficulties in motivation. |
| Secondary | Motor Function: Action Research Arm Test (ARAT) | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | The Action Research Arm Test (ARAT) is a 19-item observational measure used by healthcare professionals to assess upper extremity performance (coordination, dexterity, and functioning) in stroke recovery and brain injury. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch, and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Performance on each item is rated on a 4-point ordinal scale ranging from: 3\) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1\) Performs test partially 0) Can perform no part of test The maximum score on the ARAT is 57 points (possible range 0 to 57). A higher score indicates better functioning in the upper extremity. |
| Secondary | Motor Function: Barthel Index (BI) | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. The ten items are scored on a 4/5-item Likert scale, and then a final score is calculated by summing the points awarded to each functional skill. This allows the examiner to measure a patient's functional disability by quantifying their performance. Minimum value: 0, maximum value: 20. The higher the score, the more independent the patient is in completing the measured ADLs. Higher scores also indicate the patient is more likely to return home, with varying degrees of assistance, following hospital discharge. The lower the score, the more dependent the patient is with ADL completion. |
| Secondary | Cognition: Cancellation Wechsler Adult Intelligence Scale (WAIS-IV) | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | The WAIS-IV cancellation test measures, amongst others, processing speed, visuospatial attention and/or neglect. A score is constructed based on how many targets or false alarms are indicated within 45s. More missed targets or false alarms indicate worse performance. The test does not explicitly list minimum or maximum scores due to the nature of the test being a scaled score rather than a fixed value. However, based on the understanding that scaled scores typically range from 1 to 19, with lower scores indicating more cognitive difficulties and higher scores indicating fewer difficulties, investigators infer that the lowest possible scaled score would be around 1, and the highest possible scaled score would be around 19. This is assuming that the test follows typical scoring conventions where the mean is approximately 10 and the standard deviation is about 3 |
| Secondary | Cognition: Color-Word Interference Test, also known as Stroop test | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | The Stroop test can be used to measure a person's processing speed and interference, testing overall executive processing abilities. It is based on the difference of reading and naming ink colors of a word name when the name and color are different than when they are the same. The interference is calculated by subtracting congruent trials (only naming colors or words) with interference trials (words printed in colored ink), taking into account mistakes, with less difference in time o fewer mistakes indicating better performance. |
| Secondary | Cognition: WAIS IV Digit Span Test - Forward and Backward | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | The Digit Sequencing or Digit Span test is one of the main tools developed to measure one's working memory and attention. The Digit Span score is the length of the longest correctly repeated sequence, either forward or backward. The number of sequences of correctly recalled digits is summed to produce a raw score between 0 and 8 for each subtest, where a higher score indicates better performance. |
| Secondary | Cognition: Verbal Fluency Test | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | A verbal fluency test is a kind of test in which a participant is asked to produce as many words as possible from a category in a given time (usually 60 seconds). The phonemic verbal fluency test consists of producing as many words as possible within one minute for 3 letters (using cross-validated versions that are different at each time point). The total number of valid responses across trials excluding repeats are added to produce a total score, where a higher score indicates better performance. |
| Secondary | Cognition: Trail Making Test (TMT) | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | The trail making test assesses a wide variety of cognitive processes including attention, visual search and scanning, sequencing and shifting, psychomotor speed, abstraction, flexibility, ability to execute and modify a plan of action, and ability to switch instructions. The Trail Making Test is measured in time over 5 trials. The final score is trial 2 (number/letter-switching) trial 1 (only using numbers). The interference is scored based on the difference between trials 1 and 2, where a larger time difference indicates more interference. |
| Other | Motivation to engage in musical activities: Barcelona Music Reward Questionnaire (BMRQ) | This outcome measure will be administered once, during the baseline Test Point (TP1) (week 1). | The BMRQ measures intrinsic motivation to engage in musical activities and experience musical reward. The BMRQ examines five main facets that characterize musical reward experience in individuals: musical seeking, emotion evocation, mood regulation, social reward, and sensory-motor. The BMRQ is a 20-item questionnaire in which participants rate on a 5-point scale the extent to which they agree with statements indicating their degree of musical reward across five dimensions: musical seeking, emotion evocation, mood regulation, sensory-motor, and social reward. Scores are constructed by summing the likert scale score, ranging from 20-100. |
| Other | Quality of Life: EuroQol-5 (EQ-5D-5L) | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | The EQ-5D-5L is an outcome measure for measuring the health and health-related quality of life, assessing five important dimensions: mobility, self-care, daily activities, pain and fear/depression (5D) represented in 5 questions. Score range from 1-5 per question where a higher number is a worse outcome (score range between 1 and 25), and a visual analogue scale from 0-100 where for both a higher number is a better outcome. |
| Other | Mood: Depression Anxiety Stress Scale-21 (DASS-21) | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Scores of the Depression Anxiety Stress Scale are added up per category (depression, anxiety and stress): Depression symptoms related items: 3, 5, 10, 13, 16, 17, 21 (range from 0-21) Anxiety disorder-related items: 2, 4, 7, 9, 15, 19, 20 (range from 0-21) Stress-related items: 1, 6, 8, 11, 12, 14, 18 (range from 0-21), where a higher score indicates a worse outcome for all domains. |
| Other | Mood: Visual Analogue Mood Scale (VAMS) | Within 10 minutes before the start of each music therapy session (pre intervention) and immediately after each music therapy session (post intervention). | The VAMS consists of a 180-mm line having two circles at its respective ends that represent two opposite moods - the upper circle containing a stylized "happy" face, the lower a "sad" one. The VAMS thus allows measuring euthymia/dysthymia along a continuum. Scores are measured by locating responses on the line (min 0 - max 180). |
| Other | Personality Traits: The Big Five Index-Extra Short Form (BFI-2-XS) | This outcome measure will be administered once, during the baseline Test Point (TP1) (week 1). | The BFI-2 is a measure of the Big Five personality domains (labelled as Extraversion, Agreeableness, Conscientiousness, Negative Emotionality, and Open-Mindedness) through 15 more specific question items that are scored on a Likert scale from 1-5 and combined per personality domain (score range is 3-15 per domain). Higher scores indicate a greater tendency toward that personality trait (e.g., higher values of Conscientiousness indicate propensity to orderliness, industriousness, and dutifulness, whereas higher values of Negative Emotionality indicate propensity to anxiety, depression, and lability). |
| Other | Optimism: Life Orientation Test- Revised (LOT-R) | This outcome measure will be administered once, during the baseline Test Point (TP1) (week 1). | The LOT-R will be used to assess dispositional optimism. The 10-item LOT-R comprises a combination of direct scored, reverse-scored and filler items. All items are presented on 5-point scales, from 0 (I disagree a lot) to 4 (I agree a lot). Scores can range from 0-24, interpreted in categories, namely: 0-13: Low Optimism (High Pessimism); 14-18: Moderate Optimism; 19-24: High Optimism (Low Pessimism). |
| Other | Brief self-report of therapy expectations and satisfaction with treatment | This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7). | Brief questionnaire targeting the expectations of the participant regarding music therapy, but also other disciplines, such as physical therapy, psychology, occupational therapy, etc A likert-scale is used to indicate the expectations of the participant, from 0 (totally disagree) to 4 (totally agree), with the higher scores indicating that the patient expects that a particular discipline will/will not help them improve/ rehabilitate optimally. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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