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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Physical Medicine and Rehabilitation Department, Esperança Centre, Hospital del Mar; Parc de Salut Mar (PSMar)
RECRUITING
Barcelona
Contact Information
Primary
Jennifer Grau Sánchez, PhD
jennifergrau@euit.fdsll.cat
+0034 93 783 77 77
Backup
Dra. Cindry Ramírez Fuentes, MD
cramirez@hmar.cat
+0034 93 367 42 14
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 90
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital de L'Esperanca, Barcelona, Spain, University Rovira i Virgili
Leads: Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa

This content was sourced from clinicaltrials.gov