Pedagogy and Enriched Environment for Rehabilitation in the Home After Stroke (PEER-HOMEcare): Study Protocol for a Single-Group Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Screened Participants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •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
排除标准
- •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
研究组 & 干预措施
Enriched environment modifications in the home
Participants in this arm will receive home-based stroke rehabilitation supported by the PEER-HOMEcare approach. The intervention focuses on applying principles of enriched environments to the participant's home setting in order to increase opportunities for physical, cognitive, and social engagement during daily activities. Rehabilitation professionals will work with participants and, when appropriate, family members to identify meaningful activities, adapt the home environment, and integrate stimulating activities into everyday routines. Environmental and activity-based strategies may include modifying the home layout to encourage safe mobility, introducing materials or tasks that promote cognitive and sensory stimulation, and facilitating social interaction and participation in daily life. The goal is to create a home environment that supports exploration, activity, and engagement throughout the day alongside usual home-based rehabilitation services.
干预措施: Environmental Mapping Tool (using S.T.E.P.S) (Behavioral)
Enriched environment modifications in the home
Participants in this arm will receive home-based stroke rehabilitation supported by the PEER-HOMEcare approach. The intervention focuses on applying principles of enriched environments to the participant's home setting in order to increase opportunities for physical, cognitive, and social engagement during daily activities. Rehabilitation professionals will work with participants and, when appropriate, family members to identify meaningful activities, adapt the home environment, and integrate stimulating activities into everyday routines. Environmental and activity-based strategies may include modifying the home layout to encourage safe mobility, introducing materials or tasks that promote cognitive and sensory stimulation, and facilitating social interaction and participation in daily life. The goal is to create a home environment that supports exploration, activity, and engagement throughout the day alongside usual home-based rehabilitation services.
干预措施: Daily Diary (Behavioral)
结局指标
主要结局
Screened Participants
时间窗: Post-acute recruitment phase through hospital stay (up to 6 months)
Will be the number of potential participants that has been screened for eligibility
Number of Invited/Number of Accepted Participants
时间窗: Post-acute recruitment phase through hospital stay (up to 6 months)
Will be the number of participants that has been accepted for the trial
Number of Eligible Participants
时间窗: Post-acute recruitment phase through hospital stay (up to 6 months)
Will be the number of participants that are eligible for the trial
Recruitment Rate
时间窗: From enrolment to the start of participation in Week 1 (Preparation)
Will be the number of participants that are recruited for the study. Anticipated 15 participants per country (Norway, Sweden, Latvia) by April 2027
Retention Rate
时间窗: 3 months after the intervention period (Weeks 2-6)
Will be the percentage of participants with follow-up data at 3 months. The success criteria for retention is set at 90%.
Completion of first-week study tasks and data collection
时间窗: At the end of Week 1 (Preparation)
Percentage of participants who complete all required study procedures during the first week of participation. Completion is defined as: identifying at least three goals using the inspired Canadian Occupational Performance Measure (COPM); completing the Barthel Index (BI) questionnaire; successfully being inducted into and using wearable sensors for a minimum of 2 hours per day during the first week; completing all required self-reported and functional assessments; and completing all required environmental mapping data collection points within the participant's home environment. 80% of participants to complete all first-week protocol components.
Completion and delivery of intervention
时间窗: At the end of the Week 6 (Intervention)
Percentage of participants who receive and complete the required intervention components during the intervention period from Week 2-6. Delivery is defined as: environmental and equipment (EE) modifications implemented by a healthcare professional using our STEPS approach on at least 5 occasions during the intervention period; completion of regular home visits with a minimum frequency of one visit per week; participant use of wearable sensors for at least 2 hours per day, with successful adherence defined as more than 7 hours of sensor use per week (maximum expected use 10 hours per week); and completion of participant diary entries on at least 3 out of 5 days per week for the duration of the intervention period.
Acceptability Questionnaire (Stroke Survivor and Family Member)
时间窗: At the end of treatment (Week 6)
This questionnaire is a self-report measure for individuals with stroke and their family members that evaluates their experience with the PEER-HOMEcare intervention. It assesses how acceptable, beneficial, and engaging the treatment was, including participation, communication with therapists, motivation, and the ability to adapt daily activities and the home environment. Using a 4-point scale, it also captures perceptions of specific components such as home-based care, use of sensors, digital materials, and involvement of family, as well as the overall impact on daily functioning and goal achievement. The target is 80% answer "very much" or "entirely".
Collection and Interpretation of Sensor Data
时间窗: From Week 2 to the end of treatment (Week 6).
Percentage of intervention weeks in which sensor technology is successfully used and managed as intended. This includes weekly downloading of sensor data, collection of usable sensor data, and discussion of sensor-derived measurements within the healthcare professional team to inform environmental and equipment (EE) modifications. Usable data are defined as sensor recordings that meet the required quality and completeness criteria for interpretation by the healthcare professional. Success is defined as weekly downloading of sensor data (100% completion), at least 80% of collected sensor data during the intervention period being usable, and sensor measurements being discussed within the team at least once per week to support intervention decisions.
Use of educational resources
时间窗: From enrolment through until the 3 month follow-up.
Percentage of participants who access and use the study educational resources during the intervention period. Educational resources include the study webpage and laptop provided for accessing the patient portal. Use of the resources will be assessed by tracking participant logins to the patient portal. Successful engagement is defined as participants signing into the patient portal at least three times during the intervention period.
Fidelity to the intervention protocol by project therapists
时间窗: During the preparation (Week 1) and intervention period (Weeks 2-6), reviewed at least twice during the project period.
Percentage of intervention sessions in which project therapists adhere to the study protocol, assessed using a structured fidelity log. Therapists will complete the fidelity log to document adherence to the planned intervention procedures. Fidelity will be evaluated at least two times during the intervention period. A high level of fidelity is defined as a score of at least 85% on the fidelity log, indicating that the intervention components were delivered according to the protocol.
Participant adherence to intervention activities
时间窗: During the intervention period (weeks 2-6 of study participation).
Percentage of participants who adhere to the planned intervention activities related to their identified goals (inspired m-COPM). Adherence is defined as participants performing activities related to their individualised goals and following the STEPS-based environmental and equipment modifications as agreed upon with the healthcare professional. Successful adherence is defined as engaging in these goal-related activities at least five times per week.
Acceptability Questionnaire (Therapist)
时间窗: At the end of treatment (Week 6)
This questionnaire is a therapist-completed assessment of how the patient experienced and engaged with the PEER-HOMEcare intervention. It evaluates the therapist's perception of the patient's participation, motivation, understanding, and acceptance of the treatment, as well as the perceived benefits for daily functioning. Using a 4-point scale, it also covers aspects such as communication, adaptability to new activities and home modifications, use of sensors and digital materials, and the patient's likelihood of continuing learned strategies after the intervention. The target is 80% answer "very much" or "entirely".
Action Research Arm Test (ARAT)
时间窗: Baseline/Preparation (Week 1) and end of treatment (Week 6)
The Action Research Arm Test is a 19-item observational assessment of upper extremity motor function in individuals with stroke. The test evaluates grasp, grip, pinch, and gross arm movement. Each item is scored on a 4-point ordinal scale from 0 to 3, producing a total score ranging from 0 to 57, where higher scores indicate better upper limb motor function.
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
时间窗: Baseline/Preparation (Week 1) and end of treatment (Week 6)
The Fugl-Meyer Assessment for Upper Extremity is a standardised, performance-based measure used to assess motor recovery after stroke. The full assessment evaluates motor function, sensation, joint range of motion, and pain in the upper limb. Total scores range from 0 to 66, where higher scores indicate better motor and neurological function.
Abilhand
时间窗: Baseline/Preparation (Week 1) and end of treatment (Week 6)
The ABILHAND is a patient-reported outcome measure assessing perceived difficulty in performing manual activities using one or both hands. Participants rate activities as impossible, difficult, or easy. Responses are converted using Rasch analysis to produce a linear ability measure. Higher scores represent better perceived manual ability.
The Stroke Self-Efficacy Questionnaire (SSEQ)
时间窗: Baseline/Preparation (Week 1) and end of treatment (Week 6)
The Stroke Self-Efficacy Questionnaire is a patient-reported outcome measure assessing confidence in performing functional activities and managing life after stroke. The scale includes 13 items scored from 0 to 10, with total scores ranging from 0 to 130, where higher scores indicate greater self-efficacy.
Stroke Impact Scale (SIS)
时间窗: Baseline/Preparation (Week 1) and end of treatment (Week 6)
The Stroke Impact Scale is a 59-item patient-reported questionnaire assessing the impact of stroke across eight domains: strength, hand function, activities of daily living, mobility, communication, emotion, memory, and participation. Domain scores range from 0 to 100, where higher scores indicate better health status and function.
Barthel Index (BI)
时间窗: Baseline/Preparation (Week 1) and end of treatment (Week 6)
The Barthel Index is a 10-item measure of independence in activities of daily living, including feeding, bathing, grooming, dressing, toileting, transfers, mobility, and stair use. Scores range from 0 to 100, where higher scores indicate greater independence in daily activities.
Patient Health Questionnaire - 9 (PHQ-9)
时间窗: Baseline/Preparation (Week 1) and end of treatment (Week 6)
The Patient Health Questionnaire is a 9-item self-report measure used to screen for and assess the severity of depressive symptoms. Total scores range from 0 to 27, where higher scores indicate more severe depressive symptoms.
General Anxiety Disorder - 7 (GAD-7)
时间窗: Baseline/Preparation (Week 1) and end of treatment (Week 6)
The Generalised Anxiety Disorder is a 7-item self-report questionnaire used to assess the severity of anxiety symptoms. Total scores range from 0 to 21, where higher scores indicate greater anxiety severity.
次要结局
- Smoothness - A measure of fluidity of the upper limb(Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.)
- Use of the affected limb(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(Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.)
- Entropy - A measure of variability of the upper limb(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(Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.)
研究者
James Robert Rudd
Professor
Norwegian School of Sport Sciences