Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke

NCT ID: NCT04507542

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Enriched Music-Supported Therapy

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

Graded Repetitive Arm Supplementary Program

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Music-Supported Therapy; GRASP

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Artificial Intelligence Research Institute, Spanish National Research Council

UNKNOWN

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: collaborator

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Antoni Rodriguez Fornells

Research Professor in Catalan Institution for Research and Advanced Studies

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antoni Rodríguez Fornells, PhD

Role: PRINCIPAL_INVESTIGATOR

Bellvitge Biomedical Research Institute, University of Barcelona

Jennifer Grau Sánchez, PhD

Role: STUDY_DIRECTOR

Bellvitge Biomedical Research Institute, University of Barcelona

Locations

Bellvitge Biomedical Research Institute

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

Central Contacts

Antoni Rodríguez Fornells, PhD

Role: CONTACT

antoni.rodriguez@icrea.cat

+34934020489

Jennifer Grau Sánchez, PhD

Role: CONTACT

jennifergrau@euit.fdsll.cat

+34934020489

Facility Contacts

Research Office

Role: primary

+34932607411

References

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.

Reference Type: DERIVED

PMID: 39112892 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33435919 (View on PubMed)

Related Links

http://www.brainvitge.org

Research group webpage

Other Identifiers

201729.30

Identifier Type: -

Identifier Source: org_study_id