Stroke
Conditions
Keywords
Enriched environment, Rehabilitation, Home based rehabilitation, Upper limb motor function, Activities of Daily Living (ADL)
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALEnvironmental 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 enjoyment, which can enhance motivation and engagement in rehabilitation. The mapping process uses the S.T.E.P.S. framework (Space, Time, Equipment, People, and Safety), to analyse environmental factors influencing task performance. Therapists and participants collaboratively review each activity and consider how the home environment can be adjusted to increase opportunities for safe practice, participation, and engagement in daily life.
BEHAVIORALDaily 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 environmental strategies to support continued recovery and skill development.
Sponsors
Norwegian School of Sport Sciences
Sunnaas Rehabilitation Hospital
Göteborg University
Riga Stradins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screened Participants | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Entropy is used to quantify variability in upper limb movement during daily activities using data from wearable sensors. Entropy reflects how varied or predictable movement patterns are over time: higher entropy values indicate greater variability in movement, while lower values indicate more repetitive or consistent movement patterns. Entropy will be calculated using acceleration and orientation data from upper limb segments (general entropy) and orientation data alone to represent joint movement variability (joint entropy). Measures will be calculated either across all monitored upper limb segments or specifically for the affected upper limb. Entropy values do not have a fixed upper limit. Sensor data can be extracted across different time increments (e.g., 10 minutes, 20 minutes, 1 hour, day, or 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. | Novelty measures the occurrence of new upper limb movement patterns during daily activities. It is defined as the percentage of time in which previously unobserved segment orientations of the upper limb are detected using wearable sensors. A higher percentage indicates that a participant performed more new movement configurations, while lower values indicate fewer newly observed movements. Novelty is used to determine whether increased exploration of movement (e.g., variability measured by entropy) leads to the emergence of new movement behaviours. Sensor data can be extracted across different time increments (e.g., 10 minutes, 20 minutes, 1 hour, day, or week). |
| 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. | Smoothness measures the fluidity and coordination of upper limb movements during daily activities using wearable sensor data. The measure reflects how continuous and harmonious movements are and is influenced by factors such as changes in direction, jerkiness, abrupt movements, and variations in acceleration. Smoothness is derived from sensor-based movement data from the upper limb segments. A value of 0 represents completely smooth movement, while negative values indicate less smooth movement, reflecting increased jerkiness or abrupt changes in motion. Sensor data can be extracted across different time increments (e.g., 10 minutes, 20 minutes, 1 hour, day, or 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. | Compensation measures the extent to which trunk movements are used to assist or compensate for movements of the affected upper limb during daily activities. It is calculated using wearable sensor data as the percentage of time that the trunk and the affected upper limb move simultaneously, indicating compensatory trunk involvement during arm movements. Scores range from 0% to 100%, where 0% represents no trunk compensation (movement of the upper limb occurs without concurrent trunk movement) and higher percentages indicate greater use of trunk compensation. Sensor data from the trunk and upper limb segments are analysed to determine when these segments move together. Sensor data can be extracted across different time increments (e.g., 10 minutes, 20 minutes, 1 hour, day, or week). A reduction in compensation over time is expected during the intervention. |
| Use of the affected limb | Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week. | Use of the affected upper limb measures the percentage of time the affected arm is active during daily activities, as detected by wearable sensors placed on the upper limb segments. Movement is identified through sensor-derived acceleration and orientation data, indicating when the affected limb is being used. Scores range from 0% to 100%, where 0% indicates no detected use of the affected limb and 100% indicates continuous use during the monitored period. Higher percentages represent greater use of the affected arm in everyday activities. Sensor data can be extracted across different time increments (e.g., 10 minutes, 20 minutes, 1 hour, day, or week). |
Countries
Latvia, Norway, Sweden
Contacts
CONTACTJames R Rudd, Professor
CONTACTArve I Opheim, Associate Prof.
PRINCIPAL_INVESTIGATORJames Rudd, Professor
Norwegian School of Sport Sciences (NIH)
Outcome results
None listed