Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke

Stroke Clinical Trial

— HOMEMUSIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04507542
• Other study ID #: 201729.30
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2020
• Source: University of Barcelona
• Contact: Antoni Rodríguez Fornells, PhD
• Phone: +34934020489
• Email: antoni.rodriguez[@]icrea.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Bellvitge Biomedical Research Institute	L'Hospitalet De Llobregat	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
University of Barcelona	Artificial Intelligence Research Institute, Spanish National Research Council, University of Helsinki

Country where clinical trial is conducted

Spain, 

Outcome

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

External Links

•   Research group webpage