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

NCT07517120 | Not Yet Recruiting

• 5 other identifiers: No 1010956548163252-PĒK-4/225/2026AP/08-08.1/26/492026-00409-01
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 3

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.

Conditions

Stroke

Keywords

Enriched environment; Rehabilitation; Home based rehabilitation; Upper limb motor function; Activities of Daily Living (ADL)

Outcome Measures

Primary Outcomes (21)

• Screened Participants

  Will be the number of potential participants that has been screened for eligibility

  Post-acute recruitment phase through hospital stay (up to 6 months)

• Number of Invited/Number of Accepted Participants

  Will be the number of participants that has been accepted for the trial

  Post-acute recruitment phase through hospital stay (up to 6 months)

• Number of Eligible Participants

  Will be the number of participants that are eligible for the trial

  Post-acute recruitment phase through hospital stay (up to 6 months)

• Recruitment Rate

  Will be the number of participants that are recruited for the study. Anticipated 15 participants per country (Norway, Sweden, Latvia) by April 2027

  From enrolment to the start of participation in Week 1 (Preparation)

• Retention Rate

  Will be the percentage of participants with follow-up data at 3 months. The success criteria for retention is set at 90%.

  3 months after the intervention period (Weeks 2-6)

• Completion of first-week study tasks and data collection

  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.

  At the end of Week 1 (Preparation)

• Completion and delivery of 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.

  At the end of the Week 6 (Intervention)

• Acceptability Questionnaire (Stroke Survivor and Family Member)

  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".

  At the end of treatment (Week 6)

• Collection and Interpretation of Sensor Data

  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.

  From Week 2 to the end of treatment (Week 6).

• Use of educational resources

  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.

  From enrolment through until the 3 month follow-up.

• Fidelity to the intervention protocol by project therapists

  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.

  During the preparation (Week 1) and intervention period (Weeks 2-6), reviewed at least twice during the project period.

• Participant adherence to intervention activities

  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.

  During the intervention period (weeks 2-6 of study participation).

• Acceptability Questionnaire (Therapist)

  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".

  At the end of treatment (Week 6)

• Action Research Arm Test (ARAT)

  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.

  Baseline/Preparation (Week 1) and end of treatment (Week 6)

• Fugl-Meyer Assessment Upper Extremity (FMA-UE)

  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.

  Baseline/Preparation (Week 1) and end of treatment (Week 6)

• Abilhand

  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.

  Baseline/Preparation (Week 1) and end of treatment (Week 6)

• The Stroke Self-Efficacy Questionnaire (SSEQ)

  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.

  Baseline/Preparation (Week 1) and end of treatment (Week 6)

• Stroke Impact Scale (SIS)

  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.

  Baseline/Preparation (Week 1) and end of treatment (Week 6)

• Barthel Index (BI)

  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.

  Baseline/Preparation (Week 1) and end of treatment (Week 6)

• Patient Health Questionnaire - 9 (PHQ-9)

  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.

  Baseline/Preparation (Week 1) and end of treatment (Week 6)

• General Anxiety Disorder - 7 (GAD-7)

  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.

  Baseline/Preparation (Week 1) and end of treatment (Week 6)

Secondary Outcomes (5)

• 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.

• 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.

• 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.

• Use of the affected limb

  Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.

Other Outcomes (4)

• Shoulder Abduction and Finger Extension (SAFE)

  At screening (prior to enrolment, during baseline eligibility assessment).

• The Montreal Cognitive Assessment (MoCA)

  At screening (prior to enrolment, during baseline eligibility assessment).

• Modified Rankin Scale (mRS)

  At screening (prior to enrolment, during baseline eligibility assessment).

Study Arms (1)

Enriched environment modifications in the home

EXPERIMENTAL

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.

Behavioral: Environmental Mapping Tool (using S.T.E.P.S); Behavioral: Daily Diary

Interventions

Environmental Mapping Tool (using S.T.E.P.S) BEHAVIORAL

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.

Enriched environment modifications in the home

Daily Diary BEHAVIORAL

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.

Enriched environment modifications in the home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead
• Göteborg University: collaborator
• Riga Stradins University: collaborator
• Sunnaas Rehabilitation Hospital: collaborator

Study Sites (3)

Riga Stradins University Hospital

Riga, Latvia

Location

Sunnaas Rehabilitation Hospital

Nesoddtangen, Norway

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (2)

• Nasilowska M. [Intestinal parasites 1985]. Przegl Epidemiol. 1987;41(1):131-7. No abstract available. Polish.

  PMID: 3671747 BACKGROUND

• 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 BACKGROUND

Related Links

• A detailed description and information about the PEER HOMEcare intervention for both therapists, health care provider, stroke survivors and familiy members.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• James Rudd, Professor

  Norwegian School of Sport Sciences (NIH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James R Rudd, Professor

CONTACT

+47 46767926; jamesr@nih.no

Arve I Opheim, Associate Prof.

CONTACT

+47 98005122; arve.opheim@sunnaas.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 8, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1); NO (1); SE (1)