StrokeRehArtNCT07541560
Effects of Group Leisure Activities and Musical Training on Hospital Stroke Rehabilitation.
A study testing Standard Intensive Stroke Rehabilitation Program, Music-supported Therapy and Enriched Intervention in people with Stroke, run by Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Standard Intensive Stroke Rehabilitation Program, Music-supported Therapy and Enriched Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Physical Medicine and Rehabilitation Department, Esperança Centre, Hospital del Mar; Parc de Salut Mar (PSMar)
Barcelona, Catalonia, 08024
Jennifer Grau Sánchez, PhD, +0034 93 783 77 77, jennifergrau@euit.fdsll.cat
Cindry Ramirez Fuentes, MD, +0034 93 367 42 14, cramirez@hmar.cat
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Standard Intensive Stroke Rehabilitation Program, Music-supported Therapy, Enriched Intervention
- Keywords
- Enriched Environment, Stroke, Rehabilitation, Leisure Activities, Music-supported Therapy, Randomized Controlled Trial, Stroke Rehabilitation, Neuroplasticity, Functional autonomy, Cost-effectiveness, Patient experiences, Recovery, Feasibility
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Intensive Stroke Rehabilitation ProgramBehavioural
Also called Standard care, Intensive rehabilitation program, Intensive Inpatient 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.
Music-supported TherapyBehavioural
Also called Enriched Music-supported Therapy, Musical training
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.
Enriched InterventionBehavioural
Also called Enriched rehabilitation, Leisure activities
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Standard Intensive Stroke Rehabilitation Program; Behavioral: Enriched Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Dec 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, controlled, single-blinded, single-center trial with three intervention arms will be conducted.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- University Rovira i Virgili, Hospital de L'Esperanca, Barcelona, Spain
- Responsible party
- Sponsor
- Investigators
- Núria Codern Bové, PhD, Study chair, EUIT University Center, Autonomous University of BarcelonaMisericòrdia Carles-Lavila, PhD, Study chair, Department of Economics, Rovira i Virgili University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541560
- Sponsor's protocol ID
- PID2023-149792OA-I00
- Acronym
- RehArt
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enriched Stroke Rehabilitation Through Music and Leisure Activities: Exploring Recovery, Brain Biomarkers, and Aspects for Implementation
- ClinicalTrials.gov ID
- NCT07541560
- Acronym / sponsor ID
- RehArt / PID2023-149792OA-I00
- Conditions
- Stroke
- Keywords
- Enriched Environment, Stroke, Rehabilitation, Leisure Activities, Music-supported Therapy, Randomized Controlled Trial, Stroke Rehabilitation, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Escola Universitària d'Infermeria i Teràpia Ocupacional de TerrassaUniversity, hospital or other
- Collaborators
- University Rovira i Virgili, Hospital de L'Esperanca, Barcelona, Spain
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, controlled, single-blinded, single-center trial with three intervention arms will be conducted.
| Arm | Type | Receives |
|---|---|---|
| Standard care (usual rehabilitation program) | Active comparator | Behavioral: Standard Intensive Stroke Rehabilitation ProgramThe 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. |
| Standard care + Music-supported Therapy | Experimental | Behavioral: Standard Intensive Stroke Rehabilitation Program, Behavioral: Music-supported TherapyParticipants 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. |
| Standard care + Enriched Intervention | Experimental | Behavioral: Standard Intensive Stroke Rehabilitation Program, Behavioral: Enriched InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Intensive Stroke Rehabilitation ProgramAlso: Standard care, Intensive rehabilitation program, Intensive Inpatient Stroke Rehabilitation ProgramThe 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. | Behavioural | Standard care (usual rehabilitation program), Standard care + Enriched Intervention, Standard care + Music-supported Therapy |
| Music-supported TherapyAlso: Enriched Music-supported Therapy, Musical trainingMusic-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. | Behavioural | Standard care + Music-supported Therapy |
| Enriched InterventionAlso: Enriched rehabilitation, Leisure activitiesEnriched 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. | Behavioural | Standard care + Enriched Intervention |
Primary outcome
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)
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.
14 secondary outcomes
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)
Apathy assessed by the Apathy Evaluation Scale
Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Anxiety and depression assessed by the Hospital Anxiety and Depression Scale
Time frame: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Núria Codern Bové, PhD study chair
EUIT University Center, Autonomous University of Barcelona
Misericòrdia Carles-Lavila, PhD study chair
Department of Economics, Rovira i Virgili University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Intensive Stroke Rehabilitation Program, Music-supported Therapy and Enriched Intervention in people with Stroke, run by Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Grau Sánchez, PhD (+0034 93 783 77 77, jennifergrau@euit.fdsll.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.