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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Enriched Music-Supported Therapy
Graded Repetitive Arm Supplementary Program
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation, music therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Bellvitge Biomedical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enriched Music-Supported Therapy group

Control group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Change in Grip Strength in Kgs
Grip strength measure, Biometrics E-Link tool
Change in Grip Strength in Kgs
Grip strength measure, Biometrics E-Link tool
Change in Box and Block Test
Gross manual dexterity measure
Change in Box and Block Test
Gross manual dexterity measure
Change in Nine Hole Pegboard Test
Fine manual dexterity measure
Change in Nine Hole Pegboard Test
Fine manual dexterity measure
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.
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.
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.
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.
Change in Sustained Attention to Response Task
Sustained attention measure
Change in Sustained Attention to Response Task
Sustained attention measure
Change in Figural Memory Subtest
Visuospatial memory measure
Change in Figural Memory Subtest
Visuospatial memory measure
Change in Rey Auditory Verbal Learning Test
Verbal learning measure
Change in Rey Auditory Verbal Learning Test
Verbal learning measure
Change in Fluency Test
Verbal fluency measure
Change in Fluency Test
Verbal fluency measure
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.
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.
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.
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.
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".
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".
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.
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.

Full Information

First Posted
August 3, 2020
Last Updated
August 7, 2020
Sponsor
University of Barcelona
Collaborators
Artificial Intelligence Research Institute, Spanish National Research Council, University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT04507542
Brief Title
Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke
Acronym
HOMEMUSIC
Official Title
Playing and Singing for the Recovering Brain: Efficacy of Enriched Social-Motivational Musical Interventions in Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Barcelona
Collaborators
Artificial Intelligence Research Institute, Spanish National Research Council, University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation, music therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
A clinical researcher with expertise in stroke rehabilitation will perform the evaluations and will be blinded to participants' group allocation.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enriched Music-Supported Therapy group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Enriched Music-Supported Therapy
Other Intervention Name(s)
Music-Supported Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Graded Repetitive Arm Supplementary Program
Other Intervention Name(s)
GRASP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Action Research Arm Test
Description
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
Title
Change in Action Research Arm Test
Description
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
Secondary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Description
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
Title
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Description
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
Title
Change in Grip Strength in Kgs
Description
Grip strength measure, Biometrics E-Link tool
Time Frame
immediately after the intervention
Title
Change in Grip Strength in Kgs
Description
Grip strength measure, Biometrics E-Link tool
Time Frame
3 months after completing the intervention
Title
Change in Box and Block Test
Description
Gross manual dexterity measure
Time Frame
immediately after the intervention
Title
Change in Box and Block Test
Description
Gross manual dexterity measure
Time Frame
3 months after completing the intervention
Title
Change in Nine Hole Pegboard Test
Description
Fine manual dexterity measure
Time Frame
immediately after the intervention
Title
Change in Nine Hole Pegboard Test
Description
Fine manual dexterity measure
Time Frame
3 months after completing the intervention
Title
Change in Chedoke Arm and Hand Activity Inventory
Description
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
Title
Change in Chedoke Arm and Hand Activity Inventory
Description
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
Title
Change in Behaviour Rating Inventory of Executive Function
Description
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
Title
Change in Behaviour Rating Inventory of Executive Function
Description
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
Title
Change in Sustained Attention to Response Task
Description
Sustained attention measure
Time Frame
immediately after the intervention
Title
Change in Sustained Attention to Response Task
Description
Sustained attention measure
Time Frame
3 months after completing the intervention
Title
Change in Figural Memory Subtest
Description
Visuospatial memory measure
Time Frame
immediately after the intervention
Title
Change in Figural Memory Subtest
Description
Visuospatial memory measure
Time Frame
3 months after completing the intervention
Title
Change in Rey Auditory Verbal Learning Test
Description
Verbal learning measure
Time Frame
immediately after the intervention
Title
Change in Rey Auditory Verbal Learning Test
Description
Verbal learning measure
Time Frame
3 months after completing the intervention
Title
Change in Fluency Test
Description
Verbal fluency measure
Time Frame
immediately after the intervention
Title
Change in Fluency Test
Description
Verbal fluency measure
Time Frame
3 months after completing the intervention
Title
Change in Beck Depression Inventory-II
Description
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
Title
Change in Beck Depression Inventory-II
Description
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
Title
Change in Apathy Evaluation Scale
Description
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
Title
Change in Apathy Evaluation Scale
Description
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
Title
Change in Profile of Mood States
Description
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
Title
Change in Profile of Mood States
Description
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
Title
Change in Stroke Impact Scale
Description
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
Title
Change in Stroke Impact Scale
Description
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
Other Pre-specified Outcome Measures:
Title
Treatment Self-regulation Questionnaire
Description
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).
Time Frame
Baseline
Title
Treatment Questionnaire Concerning Continued Program
Description
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).
Time Frame
Week 5 (after the first half of the intervention)
Title
Intrinsic Motivation Inventory
Description
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).
Time Frame
immediately after the intervention
Title
Strategies Used to Promote Health Questionnaire
Description
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).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoni Rodríguez Fornells, PhD
Phone
+34934020489
Email
antoni.rodriguez@icrea.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Grau Sánchez, PhD
Phone
+34934020489
Email
jennifergrau@euit.fdsll.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Rodríguez Fornells, PhD
Organizational Affiliation
Bellvitge Biomedical Research Institute, University of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Grau Sánchez, PhD
Organizational Affiliation
Bellvitge Biomedical Research Institute, University of Barcelona
Official's Role
Study Director
Facility Information:
Facility Name
Bellvitge Biomedical Research Institute
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Office
Phone
+34932607411

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33435919
Citation
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.
Results Reference
derived
Links:
URL
http://www.brainvitge.org
Description
Research group webpage

Learn more about this trial

Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke

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