Stroke
Conditions
Keywords
Enriched Environment, Stroke, Rehabilitation, Leisure Activities, Music-supported Therapy, Randomized Controlled Trial, Stroke Rehabilitation, Neuroplasticity, Functional autonomy, Cost-effectiveness, Patient experiences, Recovery, Feasibility
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.
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
BEHAVIORALStandard 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.
BEHAVIORALMusic-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.
BEHAVIORALEnriched 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.
Sponsors
Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa
University Rovira i Virgili
Hospital de L'Esperanca, Barcelona, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
A randomized, controlled, single-blinded, single-center trial with three intervention arms will be conducted.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance in Activities of Daily Living measured by the Barthel Index | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Quality of life measured by the EQ-5D-5L. | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
| Experiences with rehabilitation assessed through semi-structured interviews with participants | 1-month Follow-up (Day 52) | Experiences, perceptions, and attitudes toward the rehabilitation program will be explored using semi-structured interviews with participants at the 1-month follow-up |
| Motor impairment assessed by the Fugl-Meyer Assessment of Motor Recovery | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
| Upper limb functional performance assessed by the Action Research Arm Test | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
| Fine manual dexterity assessed by the Nine-Hole Peg Test | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
| Gross manual dexterity assessed by the Box and Blocks Test | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
| Grip strength assessed by hand dynamometry | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | Grip strength will be assessed using a calibrated hand dynamometer. Grip force is measured in kilograms, with higher values indicating greater grip strength. |
| Global cognitive functioning assessed by the Montreal Cognitive Assessment | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
| Working memory and attention assessed by the Digit Span subtest | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
| Executive functioning assessed by the Behaviour Rating Inventory of Executive Function - Adult Version | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
| Cognitive flexibility, processing speed, and visual attention assessed by the Trail Making Test | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
| Apathy assessed by the Apathy Evaluation Scale | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
| Anxiety and depression assessed by the Hospital Anxiety and Depression Scale | Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52) | 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. |
Countries
Spain
Contacts
CONTACTJennifer Grau Sánchez, PhD
CONTACTDra. Cindry Ramírez Fuentes, MD
STUDY_CHAIRNúria Codern Bové, PhD
EUIT University Center, Autonomous University of Barcelona
STUDY_CHAIRMisericòrdia Carles-Lavila, PhD
Department of Economics, Rovira i Virgili University
Outcome results
None listed