Clinical trial NCT04507542: Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke
Official title: Playing and Singing for the Recovering Brain: Efficacy of Enriched Social-Motivational Musical Interventions in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
rehabilitation
music therapy
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Artificial Intelligence Research Institute, Spanish National Research Council
name: University of Helsinki
First posted: 2020-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in Action Research Arm Test
timeFrame: immediately after the intervention
measure: Change in Action Research Arm Test
timeFrame: 3 months after completing the intervention
Secondary outcomes:
measure: Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: immediately after the intervention
measure: Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: 3 months after completing the intervention
measure: Change in Grip Strength in Kgs
timeFrame: immediately after the intervention
measure: Change in Grip Strength in Kgs
timeFrame: 3 months after completing the intervention
measure: Change in Box and Block Test
timeFrame: immediately after the intervention
measure: Change in Box and Block Test
timeFrame: 3 months after completing the intervention
measure: Change in Nine Hole Pegboard Test
timeFrame: immediately after the intervention
measure: Change in Nine Hole Pegboard Test
timeFrame: 3 months after completing the intervention
measure: Change in Chedoke Arm and Hand Activity Inventory
timeFrame: immediately after the intervention
measure: Change in Chedoke Arm and Hand Activity Inventory
timeFrame: 3 months after completing the intervention
measure: Change in Behaviour Rating Inventory of Executive Function
timeFrame: immediately after the intervention
measure: Change in Behaviour Rating Inventory of Executive Function
timeFrame: 3 months after completing the intervention
measure: Change in Sustained Attention to Response Task
timeFrame: immediately after the intervention
measure: Change in Sustained Attention to Response Task
timeFrame: 3 months after completing the intervention
measure: Change in Figural Memory Subtest
timeFrame: immediately after the intervention
measure: Change in Figural Memory Subtest
timeFrame: 3 months after completing the intervention
measure: Change in Rey Auditory Verbal Learning Test
timeFrame: immediately after the intervention
measure: Change in Rey Auditory Verbal Learning Test
timeFrame: 3 months after completing the intervention
measure: Change in Fluency Test
timeFrame: immediately after the intervention
measure: Change in Fluency Test
timeFrame: 3 months after completing the intervention
measure: Change in Beck Depression Inventory-II
timeFrame: immediately after the intervention
measure: Change in Beck Depression Inventory-II
timeFrame: 3 months after completing the intervention
measure: Change in Apathy Evaluation Scale
timeFrame: immediately after the intervention
measure: Change in Apathy Evaluation Scale
timeFrame: 3 months after completing the intervention
measure: Change in Profile of Mood States
timeFrame: immediately after the intervention
measure: Change in Profile of Mood States
timeFrame: 3 months after completing the intervention
measure: Change in Stroke Impact Scale
timeFrame: immediately after the intervention
measure: Change in Stroke Impact Scale
timeFrame: 3 months after completing the intervention
Other outcomes:
measure: Treatment Self-regulation Questionnaire
timeFrame: Baseline
measure: Treatment Questionnaire Concerning Continued Program
timeFrame: Week 5 (after the first half of the intervention)
measure: Intrinsic Motivation Inventory
timeFrame: immediately after the intervention
measure: Strategies Used to Promote Health Questionnaire
timeFrame: Baseline
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Bellvitge Biomedical Research Institute
state: Barcelona
Study officials:
affiliation: Bellvitge Biomedical Research Institute, University of Barcelona
name: Antoni Rodríguez Fornells, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bellvitge Biomedical Research Institute, University of Barcelona
name: Jennifer Grau Sánchez, PhD
role: STUDY_DIRECTOR
References:
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.