Effects of Group Leisure Activities and Musical Training on Hospital Stroke Rehabilitation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Intensive Stroke Rehabilitation Program, Music-supported Therapy, Enriched Intervention.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Enriched Stroke Rehabilitation Through Music and Leisure Activities: Exploring Recovery, Brain Biomarkers, and Aspects for Implementation
Overview
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.
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.
Interventions
- 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. - 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. - 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.
Primary outcome measures
- Performance in Activities of Daily Living measured by the Barthel Index [Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
Secondary outcome measures (12)
- Verbal learning and memory measured by the Rey Auditory Verbal Learning Test [Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
- Quality of life measured by the EQ-5D-5L. [Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
- Experiences with rehabilitation assessed through semi-structured interviews with participants [Time frame: 1-month Follow-up (Day 52)]
- Motor impairment assessed by the Fugl-Meyer Assessment of Motor Recovery [Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
- Upper limb functional performance assessed by the Action Research Arm Test [Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
- Fine manual dexterity assessed by the Nine-Hole Peg Test [Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
- Gross manual dexterity assessed by the Box and Blocks Test [Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
- Grip strength assessed by hand dynamometry [Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
- Global cognitive functioning assessed by the Montreal Cognitive Assessment [Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
- Working memory and attention assessed by the Digit Span subtest [Time frame: 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 [Time frame: 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 [Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Physical Medicine and Rehabilitation Department, Esperança Centre, Hospital del Mar; Parc — Barcelona
Identifiers
NCT: NCT07541560 · PID2023-149792OA-I00