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

NCT07541560 | Recruiting

• 1 other identifier: PID2023-149792OA-I00
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Enriched Environment; Stroke; Rehabilitation; Leisure Activities; Music-supported Therapy; Randomized Controlled Trial; Stroke Rehabilitation; Neuroplasticity; Functional autonomy; Cost-effectiveness; Patient experiences; Recovery; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Verbal learning and memory measured by the Rey Auditory Verbal Learning Test

  Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)

• Quality of life measured by the EQ-5D-5L.

  Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)

• Experiences with rehabilitation assessed through semi-structured interviews with participants

  1-month Follow-up (Day 52)

• Motor impairment assessed by the Fugl-Meyer Assessment of Motor Recovery

  Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)

• Upper limb functional performance assessed by the Action Research Arm Test

  Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)

Study Arms (3)

Standard care (usual rehabilitation program)

ACTIVE COMPARATOR

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

Standard care + Music-supported Therapy

EXPERIMENTAL

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; Behavioral: Music-supported Therapy

Standard care + Enriched Intervention

EXPERIMENTAL

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; Behavioral: Enriched Intervention

Interventions

Standard Intensive Stroke Rehabilitation Program BEHAVIORAL

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.

Also known as: Standard care, Intensive rehabilitation program, Intensive Inpatient Stroke Rehabilitation Program

Standard care (usual rehabilitation program); Standard care + Enriched Intervention; Standard care + Music-supported Therapy

Music-supported Therapy BEHAVIORAL

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.

Also known as: Enriched Music-supported Therapy, Musical training

Standard care + Music-supported Therapy

Enriched Intervention BEHAVIORAL

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.

Also known as: Enriched rehabilitation, Leisure activities

Standard care + Enriched Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa: lead
• University Rovira i Virgili: collaborator
• Hospital de L'Esperanca, Barcelona, Spain: collaborator

Study Sites (1)

Physical Medicine and Rehabilitation Department, Esperança Centre, Hospital del Mar; Parc de Salut Mar (PSMar)

Barcelona, Catalonia, 08024, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• 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 CHAIR

Central Study Contacts

Jennifer Grau Sánchez, PhD

CONTACT

+0034 93 783 77 77; jennifergrau@euit.fdsll.cat

Dra. Cindry Ramírez Fuentes, MD

CONTACT

+0034 93 367 42 14; cramirez@hmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluation, including performance outcomes and self-reported questionnaires, will be administered by a research assistant who is blinded to each participant's group allocation. Although participants are necessarily aware of the rehabilitation activities they receive, they are not told which activities are considered experimental, nor are they informed about the study hypotheses or comparisons.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, controlled, single-blinded, single-center trial with three intervention arms will be conducted.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: April 21, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

ES (1)