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

August 7, 2020 updated by: Antoni Rodriguez Fornells, University of Barcelona

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Bellvitge Biomedical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Action Research Arm Test
Time Frame: immediately after 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.
immediately after the intervention
Change in Action Research Arm Test
Time Frame: 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.
3 months after completing the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Time Frame: immediately after 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.
immediately after the intervention
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Time Frame: 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.
3 months after completing the intervention
Change in Grip Strength in Kgs
Time Frame: immediately after the intervention
Grip strength measure, Biometrics E-Link tool
immediately after the intervention
Change in Grip Strength in Kgs
Time Frame: 3 months after completing the intervention
Grip strength measure, Biometrics E-Link tool
3 months after completing the intervention
Change in Box and Block Test
Time Frame: immediately after the intervention
Gross manual dexterity measure
immediately after the intervention
Change in Box and Block Test
Time Frame: 3 months after completing the intervention
Gross manual dexterity measure
3 months after completing the intervention
Change in Nine Hole Pegboard Test
Time Frame: immediately after the intervention
Fine manual dexterity measure
immediately after the intervention
Change in Nine Hole Pegboard Test
Time Frame: 3 months after completing the intervention
Fine manual dexterity measure
3 months after completing the intervention
Change in Chedoke Arm and Hand Activity Inventory
Time Frame: immediately after 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.
immediately after the intervention
Change in Chedoke Arm and Hand Activity Inventory
Time Frame: 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.
3 months after completing the intervention
Change in Behaviour Rating Inventory of Executive Function
Time Frame: immediately after 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.
immediately after the intervention
Change in Behaviour Rating Inventory of Executive Function
Time Frame: 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.
3 months after completing the intervention
Change in Sustained Attention to Response Task
Time Frame: immediately after the intervention
Sustained attention measure
immediately after the intervention
Change in Sustained Attention to Response Task
Time Frame: 3 months after completing the intervention
Sustained attention measure
3 months after completing the intervention
Change in Figural Memory Subtest
Time Frame: immediately after the intervention
Visuospatial memory measure
immediately after the intervention
Change in Figural Memory Subtest
Time Frame: 3 months after completing the intervention
Visuospatial memory measure
3 months after completing the intervention
Change in Rey Auditory Verbal Learning Test
Time Frame: immediately after the intervention
Verbal learning measure
immediately after the intervention
Change in Rey Auditory Verbal Learning Test
Time Frame: 3 months after completing the intervention
Verbal learning measure
3 months after completing the intervention
Change in Fluency Test
Time Frame: immediately after the intervention
Verbal fluency measure
immediately after the intervention
Change in Fluency Test
Time Frame: 3 months after completing the intervention
Verbal fluency measure
3 months after completing the intervention
Change in Beck Depression Inventory-II
Time Frame: immediately after 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.
immediately after the intervention
Change in Beck Depression Inventory-II
Time Frame: 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.
3 months after completing the intervention
Change in Apathy Evaluation Scale
Time Frame: immediately after 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.
immediately after the intervention
Change in Apathy Evaluation Scale
Time Frame: 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.
3 months after completing the intervention
Change in Profile of Mood States
Time Frame: immediately after 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".
immediately after the intervention
Change in Profile of Mood States
Time Frame: 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".
3 months after completing the intervention
Change in Stroke Impact Scale
Time Frame: immediately after 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.
immediately after the intervention
Change in Stroke Impact Scale
Time Frame: 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.
3 months after completing the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment Self-regulation Questionnaire
Time Frame: Baseline
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
Time Frame: Week 5 (after the first half of the intervention)
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
Time Frame: immediately after the intervention
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
Time Frame: Baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Helsinki
Artificial Intelligence Research Institute, Spanish National Research Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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