Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke

NCT04507542 | Unknown

• 1 other identifier: 201729.30
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; rehabilitation; music therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (28)

• Change in Fugl-Meyer Assessment of Motor Recovery after Stroke

  immediately after the intervention

• Change in Fugl-Meyer Assessment of Motor Recovery after Stroke

  3 months after completing the intervention

• Change in Grip Strength in Kgs

  immediately after the intervention

• Change in Grip Strength in Kgs

  3 months after completing the intervention

• Change in Box and Block Test

  immediately after the intervention

Other Outcomes (4)

• Treatment Self-regulation Questionnaire

  Baseline

• Treatment Questionnaire Concerning Continued Program

  Week 5 (after the first half of the intervention)

• Intrinsic Motivation Inventory

  immediately after the intervention

Study Arms (2)

Enriched Music-Supported Therapy group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Enriched Music-Supported Therapy BEHAVIORAL

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.

Also known as: Music-Supported Therapy

Enriched Music-Supported Therapy group

Graded Repetitive Arm Supplementary Program BEHAVIORAL

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.

Also known as: GRASP

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Barcelona: lead
• Artificial Intelligence Research Institute, Spanish National Research Council: collaborator
• University of Helsinki: collaborator

Study Sites (1)

Bellvitge Biomedical Research Institute

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Related Publications (2)

• Segura E, Grau-Sanchez J, Cerda-Company X, Porto MF, De la Cruz-Puebla M, Sanchez-Pinsach D, Cerquides J, Duarte E, Palumbo A, Turry A, Raghavan P, Sarkamo T, Munte TF, Arcos JL, Rodriguez-Fornells A. Enriched music-supported therapy for individuals with chronic stroke: a randomized controlled trial. J Neurol. 2024 Oct;271(10):6606-6617. doi: 10.1007/s00415-024-12570-3. Epub 2024 Aug 7.

  PMID: 39112892 DERIVED

• 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.

  PMID: 33435919 DERIVED

Related Links

• Research group webpage

MeSH Terms

Conditions

Stroke

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Antoni Rodríguez Fornells, PhD

  Bellvitge Biomedical Research Institute, University of Barcelona

  PRINCIPAL INVESTIGATOR

• Jennifer Grau Sánchez, PhD

  Bellvitge Biomedical Research Institute, University of Barcelona

  STUDY DIRECTOR

Central Study Contacts

Antoni Rodríguez Fornells, PhD

CONTACT

+34934020489; antoni.rodriguez@icrea.cat

Jennifer Grau Sánchez, PhD

CONTACT

+34934020489; jennifergrau@euit.fdsll.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A clinical researcher with expertise in stroke rehabilitation will perform the evaluations and will be blinded to participants' group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor in Catalan Institution for Research and Advanced Studies

Model Details: 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).

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 11, 2020
• Study Start: September 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)