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

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorwegian School of Sport Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Enriched environment modifications in the homeExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Screened Participants

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

Time frame
Post-acute recruitment phase through hospital stay (up to 6 months)
2

Number of Invited/Number of Accepted Participants

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

Time frame
Post-acute recruitment phase through hospital stay (up to 6 months)
3

Number of Eligible Participants

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

Time frame
Post-acute recruitment phase through hospital stay (up to 6 months)
4

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

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

Secondary outcomes

1

Entropy - A measure of variability of the upper limb

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).

Time frame
Weekly measurements collected during the intervention period (Weeks 2-6 for each participant). Data will be extracted and analysed once per week.
2

Novelty - A measure of new movements

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).

Time frame
Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.
3

Smoothness - A measure of fluidity of the upper limb

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).

Time frame
Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.
4

Compensation - A measure of the trunk to assist the affected upper limb

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.

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

Other outcomes

1

Shoulder Abduction and Finger Extension (SAFE)

The Shoulder Abduction and Finger Extension score is a clinical tool used to predict upper limb function and muscular strength. It assesses the strength from excellent to poor of shoulder abduction and finger extension using a scale (0-5), with the combined scores (0-10), where higher scores indicate greater muscle strength and better motor function. It will be used as a screening tool upon enrolment, with participants need to score at least 4/10 points.

Time frame
At screening (prior to enrolment, during baseline eligibility assessment).
2

The Montreal Cognitive Assessment (MoCA)

The Montreal Cognitive Assessment is a 10-minute screening tool used to detect mild cognitive impairment (MCI), assessing domains like memory, executive function, and orientation. Scored out of 30, a score of 26 or higher is considered normal cognitive function, developed to identify subtle cognitive changes. Participants must score 10 or higher to be eligible for the study.

Time frame
At screening (prior to enrolment, during baseline eligibility assessment).
3

Modified Rankin Scale (mRS)

The Modified Rankin Scale is a 7-level clinician-reported scale (0-6) used to measure the degree of disability or dependence in daily activities for stroke survivors, ranging from no symptoms (0) to death (6). Participants would need to from 0-3 or 4, depending on their level of support.

Time frame
At screening (prior to enrolment, during baseline eligibility assessment).
4

Adverse Events

We want to report on any serious adverse events during the intervention. The target is to have no detected adverse events (falls and injuries etc).

Time frame
From Week 1 to Week 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Norwegian School of Sport Sciences

Lead sponsor

Sunnaas Rehabilitation Hospital

Collaborator

Göteborg University

Collaborator

Riga Stradins University

Collaborator

Source ClinicalTrials.gov

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