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Идёт набор NCT07541560

Effects of Group Leisure Activities and Musical Training on Hospital Stroke Rehabilitation.

Без фазы С лечением Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard Intensive Stroke Rehabilitation Program, Music-supported Therapy, Enriched Intervention.
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.
  • Поведенческое 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.
  • Поведенческое 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.

Первичные конечные точки

  • Performance in Activities of Daily Living measured by the Barthel Index [Срок оценки: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
Вторичные конечные точки (12)
  • Verbal learning and memory measured by the Rey Auditory Verbal Learning Test [Срок оценки: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
  • Quality of life measured by the EQ-5D-5L. [Срок оценки: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
  • Experiences with rehabilitation assessed through semi-structured interviews with participants [Срок оценки: 1-month Follow-up (Day 52)]
  • Motor impairment assessed by the Fugl-Meyer Assessment of Motor Recovery [Срок оценки: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
  • Upper limb functional performance assessed by the Action Research Arm Test [Срок оценки: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
  • Fine manual dexterity assessed by the Nine-Hole Peg Test [Срок оценки: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
  • Gross manual dexterity assessed by the Box and Blocks Test [Срок оценки: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
  • Grip strength assessed by hand dynamometry [Срок оценки: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
  • Global cognitive functioning assessed by the Montreal Cognitive Assessment [Срок оценки: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]
  • Working memory and attention assessed by the Digit Span subtest [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (Day 1), Post-intervention (Day 22), 1-month Follow-up (Day 52)]

Критерии участия

Критерии включения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Physical Medicine and Rehabilitation Department, Esperança Centre, Hospital del Mar; Parc — Barcelona

Идентификаторы

NCT: NCT07541560 · PID2023-149792OA-I00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗