Music-Supported Therapy (MST) is a rehabilitation technique to improve the upper extremity motor function of stroke patients through playing musical instruments. A modified version of the MST protocol has been created (hereafter, referred as enriched MST, eMST) to include (i) a home-based self-training program using an app for electronic tablets and (ii) weekly group sessions of musical playing strengthening the motivational and emotional components of music playing. A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n=30) or a control GRASP intervention group (n=30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program is based on musical training, combining self-training sessions of music playing using an app for electronic tablets and music therapy group sessions.
Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program comprises self-training sessions of mass repetition of movements and task-specific exercises for the upper extremity.
Bellvitge Biomedical Research Institute
L'Hospitalet de Llobregat, Barcelona, Spain
Change in Action Research Arm Test
Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.
Time frame: immediately after the intervention
Change in Action Research Arm Test
Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.
Time frame: 3 months after completing the intervention
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Motor impairment measure. It comprises 33 items that evaluate motor impairment in the affected upper limb. The test is divided into 4 sections (shoulder, forearm and elbow, wrist, hand and coordination) assessing reflexes, flexor and extensor synergies, range of motion, and overall coordination and speed of the upper extremity. Each item is graded using an ordinal scale from 0 to 2. The maximum possible score is 66 and the minimal clinically important difference for chronic stroke patients is 5.2 points.
Time frame: immediately after the intervention
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Motor impairment measure. It comprises 33 items that evaluate motor impairment in the affected upper limb. The test is divided into 4 sections (shoulder, forearm and elbow, wrist, hand and coordination) assessing reflexes, flexor and extensor synergies, range of motion, and overall coordination and speed of the upper extremity. Each item is graded using an ordinal scale from 0 to 2. The maximum possible score is 66 and the minimal clinically important difference for chronic stroke patients is 5.2 points.
Time frame: 3 months after completing the intervention
Change in Grip Strength in Kgs
Grip strength measure, Biometrics E-Link tool
Time frame: immediately after the intervention
Change in Grip Strength in Kgs
Grip strength measure, Biometrics E-Link tool
Time frame: 3 months after completing the intervention
Change in Box and Block Test
Gross manual dexterity measure
Time frame: immediately after the intervention
Change in Box and Block Test
Gross manual dexterity measure
Time frame: 3 months after completing the intervention
Change in Nine Hole Pegboard Test
Fine manual dexterity measure
Time frame: immediately after the intervention
Change in Nine Hole Pegboard Test
Fine manual dexterity measure
Time frame: 3 months after completing the intervention
Change in Chedoke Arm and Hand Activity Inventory
Motor performance in activities of daily living measure. The test is composed of 13 different tasks (i.e. open a jar of coffee, make a phone call, clean a pair of eyeglasses) and each task is graded using an ordinal scale from 1 to 7. Maximum score is 91, indicating good performance.
Time frame: immediately after the intervention
Change in Chedoke Arm and Hand Activity Inventory
Motor performance in activities of daily living measure. The test is composed of 13 different tasks (i.e. open a jar of coffee, make a phone call, clean a pair of eyeglasses) and each task is graded using an ordinal scale from 1 to 7. Maximum score is 91, indicating good performance.
Time frame: 3 months after completing the intervention
Change in Behaviour Rating Inventory of Executive Function
Executive function measure. It comprises 75 items describing various behaviours, and the participant is asked to report if the behaviour is never a problem, sometimes a problem or often a problem.
Time frame: immediately after the intervention
Change in Behaviour Rating Inventory of Executive Function
Executive function measure. It comprises 75 items describing various behaviours, and the participant is asked to report if the behaviour is never a problem, sometimes a problem or often a problem.
Time frame: 3 months after completing the intervention
Change in Sustained Attention to Response Task
Sustained attention measure
Time frame: immediately after the intervention
Change in Sustained Attention to Response Task
Sustained attention measure
Time frame: 3 months after completing the intervention
Change in Figural Memory Subtest
Visuospatial memory measure
Time frame: immediately after the intervention
Change in Figural Memory Subtest
Visuospatial memory measure
Time frame: 3 months after completing the intervention
Change in Rey Auditory Verbal Learning Test
Verbal learning measure
Time frame: immediately after the intervention
Change in Rey Auditory Verbal Learning Test
Verbal learning measure
Time frame: 3 months after completing the intervention
Change in Fluency Test
Verbal fluency measure
Time frame: immediately after the intervention
Change in Fluency Test
Verbal fluency measure
Time frame: 3 months after completing the intervention
Change in Beck Depression Inventory-II
Depression measure. It comprises 21 multiple-choice questions that are scored on a scale from 0 to 3. The participant is asked about feelings, thoughts and behaviours of the past week. Higher scores indicate depression severity and the maximum possible score of the measure is 63.
Time frame: immediately after the intervention
Change in Beck Depression Inventory-II
Depression measure. It comprises 21 multiple-choice questions that are scored on a scale from 0 to 3. The participant is asked about feelings, thoughts and behaviours of the past week. Higher scores indicate depression severity and the maximum possible score of the measure is 63.
Time frame: 3 months after completing the intervention
Change in Apathy Evaluation Scale
Apathy measure. The scale comprises a self and informant reports both consisting of 18 items that are scored on a 4-point Likert scale, where higher scores indicate more apathy.
Time frame: immediately after the intervention
Change in Apathy Evaluation Scale
Apathy measure. The scale comprises a self and informant reports both consisting of 18 items that are scored on a 4-point Likert scale, where higher scores indicate more apathy.
Time frame: 3 months after completing the intervention
Change in Profile of Mood States
Mood measure. The measure includes 65 items that are scored on a 5-point Likert scale ranging from 0 "not at all" to 4 "extremely".
Time frame: immediately after the intervention
Change in Profile of Mood States
Mood measure. The measure includes 65 items that are scored on a 5-point Likert scale ranging from 0 "not at all" to 4 "extremely".
Time frame: 3 months after completing the intervention
Change in Stroke Impact Scale
Quality of life measure. It is a 59-item self-report questionnaire that assesses muscle strength, hand function, basic and instrumental activities of daily living, global mobility, communication, emotion, memory and thinking, and participation.
Time frame: immediately after the intervention
Change in Stroke Impact Scale
Quality of life measure. It is a 59-item self-report questionnaire that assesses muscle strength, hand function, basic and instrumental activities of daily living, global mobility, communication, emotion, memory and thinking, and participation.
Time frame: 3 months after completing the intervention
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