Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke
- Conditions
- Stroke
- Interventions
- Behavioral: Enriched Music-Supported TherapyBehavioral: Graded Repetitive Arm Supplementary Program
- Registration Number
- NCT04507542
- Lead Sponsor
- University of Barcelona
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enriched Music-Supported Therapy group Enriched Music-Supported Therapy 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). Control group Graded Repetitive Arm Supplementary Program 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).
- Primary Outcome Measures
Name Time Method Change in Action Research Arm Test 3 months after completing the intervention 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.
- Secondary Outcome Measures
Name Time Method Change in Fluency Test 3 months after completing the intervention Verbal fluency measure
Change in Sustained Attention to Response Task 3 months after completing the intervention Sustained attention measure
Change in Rey Auditory Verbal Learning Test 3 months after completing the intervention Verbal learning measure
Change in Nine Hole Pegboard Test 3 months after completing the intervention Fine manual dexterity measure
Change in Beck Depression Inventory-II 3 months after completing the intervention 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.
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke 3 months after completing the intervention 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.
Change in Grip Strength in Kgs 3 months after completing the intervention Grip strength measure, Biometrics E-Link tool
Change in Box and Block Test 3 months after completing the intervention Gross manual dexterity measure
Change in Chedoke Arm and Hand Activity Inventory 3 months after completing the intervention 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.
Change in Behaviour Rating Inventory of Executive Function 3 months after completing the intervention 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.
Change in Figural Memory Subtest 3 months after completing the intervention Visuospatial memory measure
Change in Apathy Evaluation Scale 3 months after completing the intervention 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.
Change in Profile of Mood States 3 months after completing the intervention 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".
Change in Stroke Impact Scale 3 months after completing the intervention 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.
Trial Locations
- Locations (1)
Bellvitge Biomedical Research Institute
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain