Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Playing and Singing for the Recovering Brain: Efficacy of Enriched Social-Motivational Musical Interventions in Stroke Rehabilitation

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Enriched Music-Supported Therapy
* Behavioral: Graded Repetitive Arm Supplementary Program


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Presence of mild-to-moderate paresis of the upper extremity after a stroke (having a score between 1 and 4 in the Medical Research Council Scale for Muscle Strength at the distal muscles of the upper extremity); More than 6 months post-stroke; Completion of formal rehabilitation programs. Exclusion criteria: Major language or cognitive deficits affecting comprehension (Mini-Mental State Examination < 24); Neurological or psychiatric co-morbidity; Other musculoskeletal condition affecting upper extremity motor function (e.g. fracture or arthritis).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A parallel-group randomised controlled trial will be conducted with participants being randomised to either an enriched Music-Supported Therapy group or to a control treatment group receiving the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enriched Music-Supported Therapy group<br>Participants in the eMST-group will follow a 10-week program of Enriched Music-Supported Therapy. The program comprises 3 individual self-training sessions and 1 group session per week (total program duration: 40 hours). | Behavioral: Enriched Music-Supported Therapy<br>* 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.<br>* Other names: Music-Supported Therapy;|
| Active Comparator: Control group<br>Participants in the control intervention group will follow the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009). They will be asked to complete 4 weekly one-hour session for 10 weeks (total program duration: 40 hours). | Behavioral: Graded Repetitive Arm Supplementary Program<br>* 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.<br>* Other names: GRASP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months after completing the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months after completing the intervention | 
| Change in Grip Strength in Kgs | Grip strength measure, Biometrics E-Link tool | immediately after the intervention | 
| Change in Grip Strength in Kgs | Grip strength measure, Biometrics E-Link tool | 3 months after completing the intervention | 
| Change in Box and Block Test | Gross manual dexterity measure | immediately after the intervention | 
| Change in Box and Block Test | Gross manual dexterity measure | 3 months after completing the intervention | 
| Change in Nine Hole Pegboard Test | Fine manual dexterity measure | immediately after the intervention | 
| Change in Nine Hole Pegboard Test | Fine manual dexterity measure | 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. | 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. | 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. | 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. | 3 months after completing the intervention | 
| Change in Sustained Attention to Response Task | Sustained attention measure | immediately after the intervention | 
| Change in Sustained Attention to Response Task | Sustained attention measure | 3 months after completing the intervention | 
| Change in Figural Memory Subtest | Visuospatial memory measure | immediately after the intervention | 
| Change in Figural Memory Subtest | Visuospatial memory measure | 3 months after completing the intervention | 
| Change in Rey Auditory Verbal Learning Test | Verbal learning measure | immediately after the intervention | 
| Change in Rey Auditory Verbal Learning Test | Verbal learning measure | 3 months after completing the intervention | 
| Change in Fluency Test | Verbal fluency measure | immediately after the intervention | 
| Change in Fluency Test | Verbal fluency measure | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3 months after completing the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, rehabilitation, music therapy