Effects of Group Leisure Activities and Musical Training on Hospital Stroke Rehabilitation. (RehArt)

Enriched Stroke Rehabilitation Through Music and Leisure Activities: Exploring Recovery, Brain Biomarkers, and Aspects for Implementation

The goal of this clinical trial is to learn whether adding group leisure activities and musical training can help people recover better after a stroke during their hospital rehabilitation. The study will include adults who had a recent stroke and are staying in the neurological rehabilitation unit.

The main questions the study aims to answer are:

Does adding leisure activities and musical training help people become more independent in their daily activities? Does this combined approach improve movement, thinking skills, mood, and quality of life more than standard rehabilitation alone?

Researchers will compare three groups to see which approach works best:

Standard hospital rehabilitation. Standard rehabilitation plus individual musical training. Standard rehabilitation plus group leisure activities and group musical training.

Participants will:

Take part in their usual rehabilitation sessions in the hospital. Depending on their assigned group, also do individual or group musical training and/or group leisure activities.

Complete evaluations at the start of the study, at hospital discharge, and one month later.

Have a brain scan and wear a wrist device that tracks daily movement. Share their experiences in an interview.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Standard Intensive Stroke Rehabilitation Program; Behavioral: Music-supported Therapy; Behavioral: Enriched Intervention

Detailed Description

Stroke rehabilitation often takes place in environments where patients spend most of their day inactive, alone, or without access to stimulating activities. This is concerning given the limited sensitive period of heightened neuroplasticity following stroke, during which recovery potential is maximized. Preclinical evidence shows that enriched environments-characterized by social, cognitive, and physical stimulation-combined with task-specific training significantly enhance recovery. However, translation of enriched interventions to clinical stroke rehabilitation remains limited.

This trial aims to evaluate the effect of adding group leisure activities and musical training (enriched intervention) to a standard rehabilitation program delivered at the hospital, comparing this enriched intervention with standard care alone and standard care combined with individual musical training. A randomised controlled trial will be conducted to test the clinical effectiveness of these interventions in enhancing recovery, studying structural brain biomarkers, and individual differences (including variables that are influenced by biological and cultural differences between men and women) in the recovery response. Moreover, the experiences of patients and healthcare professionals will be explored, as well as feasibility and cost-effectiveness of the intervention.

This project represents an opportunity to enhance translational research, applying preclinical and basic research findings to clinical practice, and testing a novel intervention that potentially improves recovery of patients and meets their needs. Modifying hospital environments with opportunities for leisure activities contributes to enhancing health services, introducing cultural and human occupation aspects in patient care.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Grau Sánchez, PhD; Phone Number: +0034 93 783 77 77; Email: jennifergrau@euit.fdsll.cat
• Study Contact Backup: Name: Dra. Cindry Ramírez Fuentes, MD; Phone Number: +0034 93 367 42 14; Email: cramirez@hmar.cat

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08024
      • Recruiting
      • Physical Medicine and Rehabilitation Department, Esperança Centre, Hospital del Mar; Parc de Salut Mar (PSMar)
      • Contact: Jennifer Grau Sánchez, PhD; Phone Number: +0034 93 783 77 77; Email: jennifergrau@euit.fdsll.cat
      • Contact: Cindry Ramirez Fuentes, MD; Phone Number: +0034 93 367 42 14; Email: cramirez@hmar.cat
      • Principal Investigator: Jennifer Grau Sánchez, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or older.
• Diagnosis of an ischemic or hemorrhagic stroke, confirmed by neuroimaging.
• Less than 4 weeks since stroke onset at the time of enrollment.
• Less than 48 hours since doctor's evaluation at the time of enrollment.
• No history of previous stroke with residual motor and/or cognitive deficits.
• Ability to provide informed consent and follow study procedures.
• Absence of neurological or mayor psychiatric conditions, or if present, only clinically stable conditions.
• Ability to understand Spanish and/or Catalan and/or English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care (usual rehabilitation program); The standard care consists of an intensive rehabilitation program during hospitalisation which follows the European stroke rehabilitation guidelines. The program aims to regain functioning, reduce patients' deficits, and improve their autonomy in basic daily activities. It follows a patient-centred approach with cyclical stages involving patient needs assessment, collaborative goal setting, therapeutic interventions, and re-assessment. The rehabilitation program comprises three hours of daily therapy (physical, occupational and speech therapy) over six days per week. Sessions are individualised, tailored to the patient's needs and graded by difficulty. The intensive rehabilitation program is described in detail in a recent publication by our team to allow replication, specifying dose, intensity, and content of each therapeutic intervention.	Behavioral: Standard Intensive Stroke Rehabilitation Program; The rehabilitation program comprises three hours of daily therapy (physical, occupational and speech therapy) over six days per week. Sessions are individualised, tailored to the patient's needs and graded by difficulty.; Other Names: Standard care; Intensive rehabilitation program; Intensive Inpatient Stroke Rehabilitation Program
Experimental: Standard care + Music-supported Therapy; Participants receive the standard rehabilitation program, which includes three 1-hour daily sessions of physical, occupational, and speech therapy. In addition, they complete a self-administered Music-supported Therapy program consisting of 1.5-hour daily sessions, five days per week. Patients use a validated tablet-based app that provides instructions for musical exercises and includes gamification features. The musical training includes task-specific activities such as learning rhythmic patterns and note sequences using percussion instruments and a MIDI piano. The MIDI piano connects to the tablet to provide real-time performance feedback. Training sessions are completed individually in the participant's hospital room at a time of their choosing, with breaks allowed as needed.	Behavioral: Standard Intensive Stroke Rehabilitation Program; The rehabilitation program comprises three hours of daily therapy (physical, occupational and speech therapy) over six days per week. Sessions are individualised, tailored to the patient's needs and graded by difficulty.; Other Names: Standard care; Intensive rehabilitation program; Intensive Inpatient Stroke Rehabilitation Program; Behavioral: Music-supported Therapy; Music-supported Therapy consists of daily self-administered individual sessions lasting 1.5-hours, five days per week. The program involves task-specific activities such as learning to play rhythmic patterns and note sequences with different percussion instruments and a MIDI piano. It aims to improve upper limb functioning, stimulate cognitive abilities, and enhance mood.; Other Names: Enriched Music-supported Therapy; Musical training
Experimental: Standard care + Enriched Intervention; Participants receive the standard rehabilitation program, which includes three 1-hour daily sessions of physical, occupational, and speech therapy. In addition, they take part in an enriched intervention that combines group leisure activities with group Music-supported Therapy. During 1.5-hour sessions held five days per week, participants engage in 45 minutes of recreational activities followed by a 45-minute musical training session in small groups of 2-3 patients. All activities take place in an enriched communal area supervised by an occupational therapist. Recreational activities include options such as reading materials, board games, puzzles, painting supplies, and other leisure items. Music-supported Therapy sessions include active and passive music-making exercises using percussion instruments and a MIDI piano. The therapist provides live musical accompaniment on piano or guitar. Participants may select preferred percussion instruments during the session.	Behavioral: Standard Intensive Stroke Rehabilitation Program; The rehabilitation program comprises three hours of daily therapy (physical, occupational and speech therapy) over six days per week. Sessions are individualised, tailored to the patient's needs and graded by difficulty.; Other Names: Standard care; Intensive rehabilitation program; Intensive Inpatient Stroke Rehabilitation Program; Behavioral: Enriched Intervention; Enriched intervention combines group leisure activities and Music-supported Therapy training in 1.5-hour daily sessions, five days per week. The program includes 45 minutes of recreational activities followed by 45-minute Music-supported Therapy group session aiming to increase activity time, provide a playful and joyful experience, and stimulate social interaction.; Other Names: Enriched rehabilitation; Leisure activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance in Activities of Daily Living measured by the Barthel Index	Performance in activities of daily living will be assessed using the Barthel Index, a validated measure of functional independence in individuals after stroke. The Barthel Index assesses performance in ten basic Activities of Daily Living, with total scores ranging from 0 to 100, where higher scores indicate greater independence and better functional performance. It´s a robust measure of performance in activities of daily living with excellent psychometric properties in hospitalised subacute stroke patients. Selecting a primary outcome in studies evaluating complex behavioural interventions is challenging because these interventions address several multiple deficits and impairments. Following the reasoning that the ultimate goal of rehabilitation is functional improvement in daily activities, the Barthel Index was selected as a primary outcome as it is widely used in clinical practice to assess the degree of functional independence following hospital discharge.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal learning and memory measured by the Rey Auditory Verbal Learning Test	Verbal learning and memory will be evaluated using the Rey Auditory Verbal Learning Test (RAVLT), which assesses immediate recall, learning capacity across repeated trials, susceptibility to interference, delayed recall, and recognition of spoken word lists.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Quality of life measured by the EQ-5D-5L.	Quality of life will be assessed using the EQ-5D-5L, which measures general health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The instrument also includes a visual analogue scale where participants rate their overall health.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Experiences with rehabilitation assessed through semi-structured interviews with participants	Experiences, perceptions, and attitudes toward the rehabilitation program will be explored using semi-structured interviews with participants at the 1-month follow-up	1-month Follow-up (Day 52)
Motor impairment assessed by the Fugl-Meyer Assessment of Motor Recovery	Motor impairment will be assessed using the Fugl-Meyer Assessment of Motor Recovery, a stroke-specific, performance-based measure designed to assess motor functioning. Total scores range from 0 to 100, with higher scores indicating less motor impairment and better motor function.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Upper limb functional performance assessed by the Action Research Arm Test	Upper limb functional performance will be assessed using the Action Research Arm Test, which evaluates grasp, grip, pinch, and gross arm movement. Total scores range from 0 to 57, with higher scores indicating better arm function.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Fine manual dexterity assessed by the Nine-Hole Peg Test	Fine manual dexterity will be assessed using the Nine-Hole Peg Test, which measures the time required to place and remove nine pegs. Scores are recorded in seconds, with lower scores indicating better performance.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Gross manual dexterity assessed by the Box and Blocks Test	Gross manual dexterity will be assessed using the Box and Blocks Test, which measures the number of blocks transferred in 60 seconds, with higher scores indicating better manual dexterity.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Grip strength assessed by hand dynamometry	Grip strength will be assessed using a calibrated hand dynamometer. Grip force is measured in kilograms, with higher values indicating greater grip strength.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Global cognitive functioning assessed by the Montreal Cognitive Assessment	Global cognitive functioning will be assessed using the Montreal Cognitive Assessment (MoCA), a screening tool designed to detect cognitive impairment across multiple domains. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Working memory and attention assessed by the Digit Span subtest	Working memory and attention will be assessed using the Digit Span subtest (forward and backward) from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). Scores are based on the number of correctly recalled digit sequences, with higher scores indicating better working memory and attentional capacity.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Executive functioning assessed by the Behaviour Rating Inventory of Executive Function - Adult Version	Executive functioning will be assessed using the Behaviour Rating Inventory of Executive Function - Adult Version (BRIEF-A), a standardized self-report questionnaire evaluating executive functions in everyday contexts. Scores are reported as T-scores, with higher scores indicating greater executive dysfunction.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Cognitive flexibility, processing speed, and visual attention assessed by the Trail Making Test	Cognitive flexibility, processing speed, and visual attention will be assessed using the Trail Making Test (Parts A and B). Performance is measured as completion time in seconds, with shorter completion times indicating better cognitive performance.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Apathy assessed by the Apathy Evaluation Scale	Apathy will be assessed using the Apathy Evaluation Scale (AES), which evaluates behavioural, cognitive, and emotional aspects of goal-directed behaviour. Total scores range from 18 to 72, with higher scores indicating greater levels of apathy.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Anxiety and depression assessed by the Hospital Anxiety and Depression Scale	Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), a self-report questionnaire consisting of two subscales: anxiety and depression. Each subscale score ranges from 0 to 21, with higher scores indicating greater symptom severity.	Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)

Collaborators and Investigators

• Sponsor: Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa
• Collaborators: University Rovira i Virgili; Hospital de L'Esperanca, Barcelona, Spain
• Investigators: Study Chair: Núria Codern Bové, PhD, EUIT University Center, Autonomous University of Barcelona; Study Chair: Misericòrdia Carles-Lavila, PhD, Department of Economics, Rovira i Virgili University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Feasibility; Recovery; Neuroplasticity; Randomized Controlled Trial; Cost-effectiveness; Functional autonomy; Stroke Rehabilitation; Patient experiences; Enriched Environment; Leisure Activities; Music-supported Therapy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: PID2023-149792OA-I00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No