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

University of Barcelona

Status: Unknown

Conditions: Stroke

Treatments: Behavioral: Graded Repetitive Arm Supplementary Program; Behavioral: Enriched Music-Supported Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04507542

201729.30

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Enriched Music-Supported Therapy group

Experimental group

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).

Treatment:

Behavioral: Enriched Music-Supported Therapy

Control group

Active Comparator group

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).

Treatment:

Behavioral: Graded Repetitive Arm Supplementary Program