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

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

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

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

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

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

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.

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.

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".

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.

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.

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.

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.

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".

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.

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.

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 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.

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.

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.

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.

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.

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 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 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 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 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).

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.

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.

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.

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).