Enriched Stroke Rehabilitation Through Music and Leisure Activities: Exploring Recovery, Brain Biomarkers, and Aspects for Implementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Performance in Activities of Daily Living measured by the Barthel Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Music-supported Therapy (Behavioral)
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.
干预措施: Standard Intensive Stroke Rehabilitation Program (Behavioral)
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.
干预措施: Standard Intensive Stroke Rehabilitation Program (Behavioral)
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.
干预措施: Standard Intensive Stroke Rehabilitation Program (Behavioral)
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.
干预措施: Enriched Intervention (Behavioral)
结局指标
主要结局
Performance in Activities of Daily Living measured by the Barthel Index
时间窗: 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.
次要结局
- Apathy assessed by the Apathy Evaluation Scale(Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52))
- 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))
- Fine manual dexterity assessed by the Nine-Hole Peg Test(Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52))
- Gross manual dexterity assessed by the Box and Blocks Test(Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52))
- Grip strength assessed by hand dynamometry(Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52))
- Global cognitive functioning assessed by the Montreal Cognitive Assessment(Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52))
- Working memory and attention assessed by the Digit Span subtest(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(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(Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52))
- Anxiety and depression assessed by the Hospital Anxiety and Depression Scale(Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52))