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Набор скоро начнётся NCT07517120

Home-Based Stroke Rehabilitation Using Enriched Environments (PEER-HOMEcare)

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: Environmental Mapping Tool (using S.T.E.P.S), Daily Diary.
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
Латвия, Норвегия, Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Pedagogy and Enriched Environment for Rehabilitation in the Home After Stroke (PEER-HOMEcare): Study Protocol for a Single-Group Feasibility Study

Обзор

The goal of this clinical trial is to learn whether the PEERHOMEcare intervention is a feasible and acceptable methodology that may have the potential to improve recovery for adults who are recovering from stroke and receiving rehabilitation at home. PEERHOMEcare adapts research on enriched environments to support brain recovery by creating stimulating and supportive home rehabilitation settings and by involving healthcare professionals and family members. The main questions it aims to answer are whether the PEERHOMEcare approach is feasible to implement in home-based stroke rehabilitation in Norway, Sweden, and Latvia, and whether it improves patient engagement and participation in rehabilitation during the first six months after stroke. Researchers will assess the delivery of the PEERHOMEcare approach to see if the intervention is feasible and acceptable and if the educational material can be used to improve engagement and recovery. Participants will receive home-based stroke rehabilitation, work with project therapists and family members to adapt their home environment to support rehabilitation activities, and complete assessments and follow-up visits to measure engagement, upper limb motor recovery, and feasibility of the intervention.

Подробное описание

Stroke is a leading cause of long-term disability worldwide and places substantial demands on healthcare systems. Recovery after stroke is influenced by the intensity, frequency, and quality of rehabilitation, particularly during the early months following the event when neuroplasticity is most pronounced. As healthcare systems increasingly shift toward shorter hospital stays and greater reliance on home-based rehabilitation, there is a growing need for innovative approaches that support recovery in the home environment. Research in neuroscience has demonstrated that enriched environments can promote neuroplasticity and functional recovery following brain injury. In animal models, enriched environments typically include increased opportunities for sensory stimulation, social interaction, cognitive engagement, and physical activity. These environments have been associated with improved motor and cognitive outcomes after experimental stroke. Translating these principles into human rehabilitation contexts remains a challenge, particularly within home-based care where environments vary widely and resources may be limited.

The PEERHOMEcare project aims to translate principles of enriched environment research into a structured approach for home-based stroke rehabilitation. The intervention integrates insights from neuroscience, rehabilitation science, and person-centred care to support recovery after discharge from hospital. The approach focuses on enhancing opportunities for activity, engagement, exploration, and participation within the home environment while considering the individual needs, preferences, and daily routines of stroke survivors.

The PEERHOMEcare intervention is designed to be delivered by project therapists in collaboration with patients and family members. The approach emphasises adapting the home environment and daily activities to increase opportunities for physical, cognitive, and social stimulation. Project therapists receive training and guidance on how to apply enriched environment principles in home-based rehabilitation. Families and informal caregivers may also be involved to help support engagement in meaningful activities throughout the day.

A key component of the intervention is the development of practical strategies to integrate rehabilitation activities into everyday routines and environments. Rather than focusing solely on structured therapy sessions, the PEERHOMEcare approach seeks to promote continuous engagement in stimulating activities throughout the day. Environmental modifications, activity planning, and collaborative goal setting are used to encourage participation and independence.

The present study evaluates the feasibility of implementing the PEER-HOMEcare intervention within home-based stroke rehabilitation services in Norway, Sweden, and Latvia. Feasibility evaluation is important before conducting larger-scale effectiveness trials, as it allows researchers to assess the practicality of implementing the intervention in real-world healthcare settings. The study will examine aspects such as the delivery of the intervention by healthcare professionals, integration within existing rehabilitation services, and participant acceptability and engagement with the intervention.

The study is conducted as a multi-country collaboration involving rehabilitation services and research institutions across the three participating countries. The cross-national design allows for exploration of how the intervention can be implemented across different healthcare systems and community care contexts. Findings will inform the refinement of the intervention and the development of implementation guidelines that may support broader adoption of enriched environment principles in home-based stroke rehabilitation.

The results of this feasibility study will contribute to the evidence base for innovative rehabilitation strategies that support recovery after stroke in community settings. If the PEERHOMEcare approach proves feasible and acceptable, it may provide a foundation for future larger trials designed to evaluate the clinical effectiveness and long-term outcomes of the intervention. Ultimately, improving engagement in rehabilitation during the critical early period after stroke may enhance functional recovery, promote independence, and improve quality of life for stroke survivors living at home.

Вмешательства

  • Поведенческое Environmental Mapping Tool (using S.T.E.P.S)
    The environmental mapping tool is used after identifying meaningful tasks with the modified Canadian Occupational Performance Measure (m-COPM). It helps therapists and participants examine how the home environment supports or limits performance of these activities and identify targeted enriched environment (EE) modifications that support rehabilitation goals. Meaningful activities are those that are personally important to the stroke survivor and linked to their identity, independence, roles, or
  • Поведенческое Daily Diary
    The daily diary is used by the stroke survivor to record practice of meaningful activities identified during rehabilitation. It helps ensure that therapy remains focused on the participant's chosen tasks and supports progression by tracking changes in difficulty, level of assistance, and independence over time. The diary also provides a structured record that can be reviewed together with the therapist to reflect on progress, identify challenges, and guide adjustments to activities or environmen

Первичные конечные точки

  • Screened Participants [Срок оценки: Post-acute recruitment phase through hospital stay (up to 6 months)]
  • Number of Invited/Number of Accepted Participants [Срок оценки: Post-acute recruitment phase through hospital stay (up to 6 months)]
  • Number of Eligible Participants [Срок оценки: Post-acute recruitment phase through hospital stay (up to 6 months)]
  • Recruitment Rate [Срок оценки: From enrolment to the start of participation in Week 1 (Preparation)]
  • Retention Rate [Срок оценки: 3 months after the intervention period (Weeks 2-6)]
  • Completion of first-week study tasks and data collection [Срок оценки: At the end of Week 1 (Preparation)]
  • Completion and delivery of intervention [Срок оценки: At the end of the Week 6 (Intervention)]
  • Acceptability Questionnaire (Stroke Survivor and Family Member) [Срок оценки: At the end of treatment (Week 6)]
  • Collection and Interpretation of Sensor Data [Срок оценки: From Week 2 to the end of treatment (Week 6).]
  • Use of educational resources [Срок оценки: From enrolment through until the 3 month follow-up.]
Вторичные конечные точки (5)
  • Entropy - A measure of variability of the upper limb [Срок оценки: Weekly measurements collected during the intervention period (Weeks 2-6 for each participant). Data will be extracted and analysed once per week.]
  • Novelty - A measure of new movements [Срок оценки: Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.]
  • Smoothness - A measure of fluidity of the upper limb [Срок оценки: Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.]
  • Compensation - A measure of the trunk to assist the affected upper limb [Срок оценки: Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.]
  • Use of the affected limb [Срок оценки: Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.]

Критерии участия

Критерии включения

  • adults (≥18 years old)
  • diagnosed with first or second haemorrhagic or ischaemic stroke
  • stroke onset no more than six months before study enrolment
  • discharged to their home following inpatient rehabilitation
  • reporting functional impairments in the upper extremity that affect functioning and participation in everyday life due to the latest stroke.
  • score at least 4 points on the Shoulder Abduction + Finger Extension (SAFE) measure.
  • adequate language skills and cognitive functioning to be able to understand intervention material, perform outcome assessments and co-operate throughout the intervention
  • willing to participate and able to provide written consent
  • consent for participation also by closest family members, if they live in the same household

Критерии исключения

  • presence of other neurological conditions
  • reported limited life expectancy due to other medical conditions during the study period
  • severe mental health disorders, including substance use disorders
  • a history of violence
  • severe communication and/or cognition deficits (MoCA below 10 points) that prevent participants from being able to participate in the intervention, understand interview questions, or study-related instructions
  • unwillingness of persons sharing the household to participate and accept the intervention
  • uncontrolled medical issues such as unstable angina, severe hypertension, or severely limiting orthopaedic conditions

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Латвия · 1 центр
  • Riga Stradins University Hospital — Riga
Норвегия · 1 центр
  • Sunnaas Rehabilitation Hospital — Nesoddtangen
Швеция · 1 центр
  • Sahlgrenska University Hospital — Gothenburg

Публикации

  • Nasilowska M. [Intestinal parasites 1985]. Przegl Epidemiol. 1987;41(1):131-7. No abstract available. Polish. PMID 3671747
  • Oppici L, Berzina G, Hestetun-Mandrup AM, Lovstad M, Opheim A, Pacheco MM, Rafsten L, Sunnerhagen KS; PEER-HOMEcare consortium; Rudd JR. A Scoping Review of Preclinical Environmental Enrichment Protocols in Models of Poststroke to Set the Foundations for Translating the Paradigm to Clinical Settings. Transl Stroke Res. 2025 Oct;16(5):1850-1873. doi: 10.1007/s12975-025-01335-3. Epub 2025 Feb 6. PMID 39913056
  • Opheim A, Oppici L, Hestetun-Mandrup AM, Sunnerhagen KS, Rafsten L, Berzina G, Karklina A, Lovstad M, Ora HP, Marcos L, Pacheco M, Fernandes A, Sorensen L, Rudd JR. Pedagogy and Enriched Environment for Rehabilitation in the HOME After Stroke (PEER-HOMEcare): Study Protocol for a Single-Group Feasibility Study. Transl Stroke Res. 2026 Jun 16;17(4):68. doi: 10.1007/s12975-026-01459-0. PMID 42301578

Идентификаторы

NCT: NCT07517120 · No 101095654 · 816325 · 2-PĒK-4/225/2026 · AP/08-08.1/26/49 · 2026-00409-01

Первоисточники (государственные реестры)

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