Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke (HOMEMUSIC)

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

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 Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Enriched Music-Supported Therapy; Behavioral: Graded Repetitive Arm Supplementary Program

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoni Rodríguez Fornells, PhD; Phone Number: +34934020489; Email: antoni.rodriguez@icrea.cat
• Study Contact Backup: Name: Jennifer Grau Sánchez, PhD; Phone Number: +34934020489; Email: jennifergrau@euit.fdsll.cat

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
      • Bellvitge Biomedical Research Institute
      • Contact: Research Office; Phone Number: +34932607411

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Enriched Music-Supported Therapy group; 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; 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.; Other Names: Music-Supported Therapy
ACTIVE_COMPARATOR: Control group; 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; 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.; Other Names: GRASP

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Self-regulation Questionnaire	Self-regulation measure. It evaluates the type of self-regulation (external, interjected, identified or intrinsic) or motivation (external or intrinsic) of the participants to engage with the rehabilitation program. It is a 15-item self-report questionnaire scored on a 7-point scale (1: not all true; 4: somewhat true; 7: very true).	Baseline
Treatment Questionnaire Concerning Continued Program	Self-regulation measure. It is a 15-item self-report questionnaire scored on a 7-point scale (1: not all true; 4: somewhat true; 7: very true).	Week 5 (after the first half of the intervention)
Intrinsic Motivation Inventory	Motivation measure. It consists of 24 self-report questions divided into six different psychological constructs reflecting positive or negative predictors of intrinsic motivation: 1) interest/enjoyment; 2) perceived competence; 3) effort/importance; 4) pressure/tension; 5) perceived choice; and 6) value/usefulness. It is scored on a 7-point scale (1: not all true; 4: somewhat true; 7: very true).	immediately after the intervention
Strategies Used to Promote Health Questionnaire	Self-efficacy measure. It is a 29-item self-report questionnaire that evaluates the degree of self-care and self-efficacy through four factors consistent with the underlying self-efficacy theory upon which the scale is based: 1) coping, 2) stress reduction, 3) making decisions, and 4) enjoying life. It is scored on a 5-point scale (from 1: very little confidence to 5: quite a lot of confidence).	Baseline

Collaborators and Investigators

• Sponsor: University of Barcelona
• Collaborators: University of Helsinki; Artificial Intelligence Research Institute, Spanish National Research Council
• Investigators: Principal Investigator: Antoni Rodríguez Fornells, PhD, Bellvitge Biomedical Research Institute, University of Barcelona; Study Director: Jennifer Grau Sánchez, PhD, Bellvitge Biomedical Research Institute, University of Barcelona

Publications and helpful links

General Publications

• Grau-Sanchez J, Segura E, Sanchez-Pinsach D, Raghavan P, Munte TF, Palumbo AM, Turry A, Duarte E, Sarkamo T, Cerquides J, Arcos JL, Rodriguez-Fornells A. Enriched Music-supported Therapy for chronic stroke patients: a study protocol of a randomised controlled trial. BMC Neurol. 2021 Jan 12;21(1):19. doi: 10.1186/s12883-020-02019-1.

Helpful Links

• Research group webpage

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (ACTUAL): August 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; music therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 201729.30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No