Perspectives of People with Stroke, Caregivers and Healthcare Professionals on an Adaptive mHealth Intervention for Physical Activity in the Prevention of Secondary Stroke: A Qualitative Study.

Introduction: Engaging in regular physical activity (PA) is associated with lower mortality following stroke, and PA reduces the chance of recurrent stroke. Despite recent guidelines to optimise PA following stroke, people with stroke are known to be less active than their age-matched counterparts. Given the heterogenous nature of stroke, adaptive PA interventions are recommended for people with stroke. Empirical data is lacking on adaptive PA or behavioural change interventions following stroke. Suggested strategies in the prevention of stroke recommend the use of mobile health (mHealth) interventions in the primary prevention of stroke. A structured stakeholder consultation process is key to successful implementation of complex interventions. This paper reports the findings of our consultation process to inform the development of an adaptive mHealth PA. Methods: We used a qualitative study design to explore the perspectives of key stakeholders on the development of an adaptive PA intervention delivered via mHealth post-stroke. Healthcare workers, carers and people with stroke participated in semi-structured one-to-one or focus group interviews. A reflexive thematic analysis was undertaken on transcribed interviews; key themes and sub-themes were developed using coding and summarised by two researchers, then reviewed by the full research team. Results: Twenty-eight stakeholders were interviewed and three main themes were identified; Key feature of a mHealth intervention, delivering a mHealth intervention, Challenges to development and use. There was widespread agreement across stakeholder groups that an adaptive mHealth PA intervention following stroke would be beneficial to people with stroke, following discharge from acute care. Conclusion: Our consultation supports the development of an adaptive PA programme that addresses specific impairments that can hinder exercise participation after stroke.

A Systematic Review of Research Gaps in the Built Environment of Inpatient Healthcare Settings.

OBJECTIVE: This study utilized the evidence-gap map method and critically examined the scope, methodologies, and focus of the studies that investigated the influence of the built environment on inpatient healthcare settings over a decade (2010-2021). METHODS: We conducted a systematic review per the preferred reporting items for systematic reviews and meta-analyses guidelines and surveyed 406 articles, primarily from North America and Europe. RESULTS: Our findings revealed a dominant focus on architectural features (73%), such as room design and ward layout. Comparatively, there was less emphasis on interior-, ambient-, social-, and nature-related features. Most previous studies explored multiple environmental features, which indicated the intricacy of this field. Research outcomes were diverse, with person-centered care (PCC) being the most frequently investigated, followed by safe care, emotional well-being, activity, and behavior. Furthermore, research methods varied considerably based on the study's outcomes and features. Clinical outcomes and safe care favored quantitative methods, activity and behavior favored mixed methods, and PCC favored qualitative research. CONCLUSION: This review provides an in-depth overview of the existing studies on healthcare design research and sheds light on the current trends and methodological choices. The insights garnered can guide future research, policy-making, and the development of healthcare facilities.

ZOom Delivered Intervention Against Cognitive decline (ZODIAC) COVID-19 pandemic adaptations to the Post-Ischaemic Stroke Cardiovascular Exercise Study (PISCES): protocol for a randomised controlled trial of remotely delivered fitness training for brain health.

BACKGROUND: Stroke increases subsequent dementia risk yet there are no specific post-stroke therapies to protect cognition. Cardiorespiratory exercise is recommended for secondary prevention of stroke and may be neuroprotective. The Post Ischaemic Stroke Cardiovascular Exercise Study (PISCES) aims to reduce post-stroke secondary neurodegeneration and cognitive decline. During the pandemic, we pivoted to a ZOom Delivered Intervention Against Cognitive decline (ZODIAC) protocol, reducing pandemic-amplified barriers to exercise. METHODS: We present pandemic adaptions for a multicentre phase IIb assessor-blinded randomised controlled trial of ischaemic stroke survivors testing the efficacy and feasibility of an 8-week home-based exercise intervention delivered at 2 months post-stroke. We compare cardiorespiratory exercise (intervention arm) versus balance and stretching (active control arm). Participants are assessed with magnetic resonance imaging (MRI), fitness, blood, microbiome, and neuropsychological tests at three study visits: before and after the exercise intervention and at 12 months. Modifications to the original protocol include pre-exercise safety home visits, commercial delivery of exercise equipment to facilitate assessor blinding, and reconsideration of statistical plan to allow pooling of the studies. We have reduced in-person study visits from 27 to 3. Primary outcome remains between-group (intervention versus control) difference in brain volume change; secondary outcome is between-group difference in global cognitive ability to allow remote administration of a validated cognitive scale. DISCUSSION: Remotely delivered exercise interventions reduce participant burden and may reduce barriers to recruitment. A decrease in the number of in-person study visits can be supported by greater information capture via self-reported questionnaires and phone surveys. TRIAL REGISTRATION: Prospectively ACTRN12616000942459. Registered on July 2016.

Perispinal Etanercept to improve STroke Outcomes (PESTO): Protocol for a multicenter, international, randomized placebo-controlled trial.

RATIONALE: A large proportion of stroke survivors will have long-lasting, debilitating neurological impairments, yet few efficacious medical treatment options are available. Etanercept inhibits binding of tumor necrosis factor to its receptor and is used in the treatment of inflammatory conditions. Perispinal subcutaneous injection followed by a supine, head down position may bypass the blood brain barrier. In observational studies and one small randomized controlled trial the majority of patients showed improvement in multiple post stroke impairments. AIM: Perispinal Etanercept to improve STroke Outcomes (PESTO) investigates whether perispinal subcutaneous injection of etanercept improves quality of life and is safe in patients with chronic, disabling, effects of stroke. METHODS AND DESIGN: PESTO is a multicenter, international, randomized placebo-controlled trial. Adult participants with a history of stroke between 1 and 15 years before enrollment and a current modified Rankin scale between 2 and 5 who are otherwise eligible for etanercept are randomized 1:1 to single dose injection of etanercept or placebo. STUDY OUTCOMES: The primary efficacy outcome is quality of life as measured using the Short Form 36 Health Inventory at day 28 after first injection. Safety outcomes include serious adverse events. SAMPLE SIZE TARGET: A total of 168 participants assuming an improvement of the SF-36 in 11% of participants in the control arm and in 30% of participants in the intervention arm, 80% power and 5% alpha. DISCUSSION: PESTO aims to provide level 1 evidence on the safety and efficacy of perispinal etanercept in patients with long-term disabling effects of stroke.

Sequential multiple assignment randomised trial to develop an adaptive mobile health intervention to increase physical activity in people poststroke in the community setting in Ireland: TAPAS trial protocol.

INTRODUCTION: Stroke is the second-leading cause of death and disability globally. Participation in physical activity (PA) is a cornerstone of secondary prevention in stroke care. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA poststroke. To this end, we aim to use a Sequential Multiple Assignment Randomised Trial (SMART) design to develop an adaptive, user-informed mHealth intervention to improve PA poststroke. METHODS AND ANALYSIS: The components included in the 12-week intervention are based on empirical evidence and behavioural change theory and will include treatments to increase participation in Structured Exercise and Lifestyle or a combination of both. 117 participants will be randomly assigned to one of the two treatment components. At 6 weeks postinitial randomisation, participants will be classified as responders or non-responders based on participants' change in step count. Non-responders to the initial treatment will be randomly assigned to a different treatment allocation. The primary outcome will be PA (steps/day), feasibility and secondary clinical and cost outcomes will also be included. A SMART design will be used to evaluate the optimum adaptive PA intervention among community-dwelling, ambulatory people poststroke. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022). The findings will be submitted for publication and presented at relevant national and international academic conferences TRIALS REGISTRATION NUMBER: NCT05606770.

Inclusion of People With Aphasia in Stroke Trials: A Systematic Search and Review.

BACKGROUND: Although people with aphasia (PwA) represent 30% of stroke survivors, they are frequently excluded from stroke research, or their inclusion is unclear. Such practice significantly limits the generalizability of stroke research, increases the need to duplicate research in aphasia-specific populations, and raises important ethical and human rights issues. OBJECTIVE: To detail the extent and nature of inclusion of PwA in contemporary stroke randomized controlled trials (RCTs). METHODS: We conducted a systematic search to identify completed stroke RCTs and RCT protocols published in 2019. Web of Science was searched using terms "stroke" and "randomized controlled trial". These articles were reviewed by extracting rates of PwA inclusion/exclusion, whether "aphasia" or related terms were referred to in the article or supplemental files, eligibility criteria, consent procedures, adaptations made to support the inclusion of PwA, and attrition rates of PwA. Data were summarized, and descriptive statistics applied when appropriate. RESULTS: 271 studies comprising 215 completed RCTs and 56 protocols were included. 36.2% of included studies referred to aphasia/dysphasia. Of completed RCTs, only 6.5% explicitly included PwA, 4.7% explicitly excluded PwA, and inclusion was unclear in the remaining 88.8%. Among RCT protocols, 28.6% of studies intended inclusion, 10.7% intended excluding PwA, and in 60.7%, inclusion was unclear. In 45.8% of included studies, sub-groups of PwA were excluded, either explicitly (ie, particular types/severities of aphasia, eg, global aphasia) or implicitly, by way of ambiguous eligibility criteria which could potentially relate to a sub-group of PwA. Little rationale for exclusion was provided. 71.2% of completed RCTs did not report any adaptations that could support the inclusion of PwA, and minimal information was provided about consent procedures. Where it could be determined, attrition of PwA averaged 10% (range 0%-20%). CONCLUSION: This paper details the extent of inclusion of PwA in stroke research and highlights opportunities for improvement.

Secondary prevention of stroke. A telehealth-delivered physical activity and diet pilot randomized trial (ENAbLE-pilot).

BACKGROUND: Improving physical activity levels and diet quality are important for secondary stroke prevention. AIM: To test the feasibility and safety of 6-month, co-designed telehealth-delivered interventions to increase physical activity and improve diet quality. METHODS: A 2 × 2 factorial trial (physical activity (PA); diet (DIET); PA + DIET; control) randomized, open-label, blinded endpoint trial. Primary outcomes were feasibility and safety. Secondary outcomes included stroke risk factors (blood pressure, self-report PA (International Physical Activity Questionnaire (IPAQ)) and diet quality (Australian Recommended Food Score (ARFS)), and quality of life. Between-group differences were analyzed using linear-mixed models. RESULTS: Over 23 months, 99 people were screened for participation and 40 (40%) randomized (3 months to 10 years post-stroke, mean age 59 (16) years). Six participants withdrew, and an additional five were lost to follow-up. Fifteen serious adverse events were reported, but none were deemed definitely or probably related to the intervention. Median attendance was 32 (of 36) PA sessions and 9 (of 10) DIET sessions. The proportion of missing primary outcome data (blood pressure) was 3% at 3 months, 11% at 6 months, and 14% at 12 months. Between-group 95% confidence intervals showed promising, clinically relevant differences in support of the interventions across the range of PA, diet quality, and blood pressure outcomes. CONCLUSION: Our telehealth PA and diet interventions were safe and feasible and may have led to significant behavior change. TRIAL REGISTRATION: ACTRN12620000189921.

Built Environments to Support Rehabilitation for People With Stroke From the Hospital to the Home (B-Sure): Protocol for a Mixed Method Participatory Co-Design Study.

BACKGROUND: A global trend is to move rehabilitation closer to people's neighborhoods and homes. Still, little attention has been given to how the built environment outside the hospital setting might impact rehabilitation and recovery for stroke survivors. OBJECTIVE: The overarching objective of this project is to develop conceptual models of built environments that support stroke rehabilitation and recovery outside the hospital setting. Specifically, the project will explore factors and characteristics of the built environment that support people with stroke and their families and identify innovative built environments that can be designed for local health care. The project will examine facilitators and obstacles for implementing built environmental solutions and evaluate the potential benefits, feasibility, and acceptability. METHODS: The project uses a mixed methods design approach with 3 phases. In phase 1, factors and characteristics of the built environment for rehabilitation will be identified. Based on the results from phase 1, phase 2 will involve co-designing prototypes of environments to support the rehabilitation process for people with stroke. Finally, the prototypes will be evaluated in phase 3. Qualitative and quantitative methods will include a literature review, a concept mapping (CM) study, stakeholder interviews, prototype development, and testing. The project will use multidimensional scaling, hierarchical cluster analysis, descriptive statistics for quantitative data, and content analysis for qualitative data. Location analysis will rely on the location-allocation model for network problems, and the rule-based analysis will be based on geographic information systems data. RESULTS: As of the submission of this protocol, ethical approval for the CM study and the interview study has been obtained. Data collection is planned to start in September 2023 and the workshops later in the same year. The scoping review is ongoing from January 2023. The CM study is ongoing and will be finalized in the spring of 2024. We expect to finish the data analysis in the second half of 2024. The project is a 3-year project and will continue until December 2025. CONCLUSIONS: We aim to determine how new environments could better support a person's control over their day, environment, goals, and ultimately control over their recovery and rehabilitation activities. This "taking charge" approach would have the greatest chance of transferring the care closer to the patient's home. By co-designing with multiple stakeholders, we aim to create solutions with the potential for rapid implementation. The project's outcomes may target other people with frail health after a hospital stay or older persons in Sweden and anywhere else. The impact and social benefits include collaboration between important stakeholders to explore how new environments can support the transition to local health care, co-design, and test of new conceptual models of environments that can promote health and well-being for people post stroke. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52489.

Immersive virtual reality gameplay detects visuospatial atypicality, including unilateral spatial neglect, following brain injury: a pilot study.

BACKGROUND: In neurorehabilitation, problems with visuospatial attention, including unilateral spatial neglect, are prevalent and routinely assessed by pen-and-paper tests, which are limited in accuracy and sensitivity. Immersive virtual reality (VR), which motivates a much wider (more intuitive) spatial behaviour, promises new futures for identifying visuospatial atypicality in multiple measures, which reflects cognitive and motor diversity across individuals with brain injuries. METHODS: In this pilot study, we had 9 clinician controls (mean age 43 years; 4 males) and 13 neurorehabilitation inpatients (mean age 59 years; 9 males) recruited a mean of 41 days post-injury play a VR visual search game. Primary injuries included 7 stroke, 4 traumatic brain injury, 2 other acquired brain injury. Three patients were identified as having left sided neglect prior to taking part in the VR. Response accuracy, reaction time, and headset and controller raycast orientation quantified gameplay. Normative modelling identified the typical gameplay bounds, and visuospatial atypicality was defined as gameplay beyond these bounds. RESULTS: The study found VR to be feasible, with only minor instances of motion sickness, positive user experiences, and satisfactory system usability. Crucially, the analytical method, which emphasized identifying 'visuospatial atypicality,' proved effective. Visuospatial atypicality was more commonly observed in patients compared to controls and was prevalent in both groups of patients-those with and without neglect. CONCLUSION: Our research indicates that normative modelling of VR gameplay is a promising tool for identifying visuospatial atypicality after acute brain injury. This approach holds potential for a detailed examination of neglect.

Stroke Inpatient Rehabilitation Environments: Aligning Building Construction and Clinical Practice Guidelines Through Care Process Mapping.

BACKGROUND: Stroke inpatient rehabilitation is a complex process involving stroke survivors, staff, and family utilizing a common space for a shared purpose: to optimize recovery. This complex pathway is rarely fully described. Stroke care is ideally guided by Clinical Practice Guidelines, and the rehabilitation built environment should serve to optimize care delivery, patient and staff experience. We aimed to articulate the inpatient stroke rehabilitation process of care in a series of process maps, and to understand the degree to which current stroke clinical and building construction (ie, design) guidelines align to support inpatient stroke rehabilitation. METHODS: We used the Value-Focused Process Engineering methodology to create maps describing the events and activities that typically occur in the current stroke inpatient rehabilitation service model. These maps were completed through individual and group session consultations with stroke survivors, architects, policy makers, and clinical experts. We then determined which sections of the Australian Stroke Rehabilitation Guidelines and the Australasian Health Facility Design Guidelines could be aligned and applied to the process maps. RESULTS: We present a summary process map for stroke inpatient rehabilitation, alongside detailed process maps for 4 different phases of rehabilitation (admission, a normal weekday, a weekend day, and discharge) using Value-Focused Process Engineering notation. The integration of design and clinical guidelines with care pathway maps revealed where guidelines lack detail to be readily linked to current stroke inpatient care practice, providing an opportunity to design stroke inpatient rehabilitation spaces based on the activities occurring within them. CONCLUSIONS: Our findings highlight gaps where clinical and design experts should work together to use guidelines to their full potential; and to improve the process of planning for future stroke rehabilitation units.

Stroke survivors' perspectives on decision-making about rehabilitation and the prospect of taking recovery-promoting drugs: A qualitative study.

Objectives: To investigate factors which influence stroke survivors' decision-making about their rehabilitation and the prospect of taking recovery-promoting drugs, to enhance their recovery. Methods: Seventeen stroke survivors who had undertaken stroke rehabilitation, and three spouses, participated in focus groups and individual interviews in northern Queensland, Australia. Inductive thematic analysis of the interview data was conducted in accordance with Braun and Clarke's six-phase process. Results: Two specific, pivotal decision points during participants' stroke recovery process were identified: 1) overall, when deciding what rehabilitation they would undertake and hypothetically what recovery-promoting drugs they would take, and 2) on a daily basis, when deciding whether to participate in rehabilitation and take recovery-promoting drugs on any given day. Six themes which described factors influencing their decision-making were: 'My options for rehabilitation and recovery-promoting drugs'; 'The costs of rehabilitation and recovery-promoting drugs'; 'My recovery goals'; 'What I can deal with today'; 'The people my rehabilitation and recovery-promoting drugs affect'; and 'Fitting rehabilitation and recovery-promoting drugs into my life.' These themes were applicable at either one or both of the identified decision points. Conclusion: Factors that influence stroke survivors' decision-making, overall and on a day-to-day basis, need to be considered to ensure they can make the best decisions for themselves to achieve their full recovery potential. Understanding the conditions under which a stroke survivor would take a recovery-promoting drug will contribute to the development of dosing protocols to which stroke survivors could adhere.

"Wasting time": a qualitative study of stroke survivors' experiences of boredom in non-therapy time during inpatient rehabilitation.

PURPOSE: Stroke survivors regularly report experiencing boredom during inpatient rehabilitation which may detrimentally affect mood, learning and engagement in activities important for functional recovery. This study explores how stroke survivors meaningfully occupy their non-therapy time and their experiences of boredom, to further our understanding of this complex phenomenon. METHODS: Secondary analysis of transcripts from semi-structured interviews with stroke survivors exploring activity during non-therapy time. Transcripts were coded and analysed using a hybrid approach of inductive and deductive thematic analysis, guided by a published boredom framework. RESULTS: Analysis of 58 interviews of 36 males and 22 females, median age 70 years, revealed four main themes: (i) Resting during non-therapy time is valued, (ii) Managing "wasted" time, (iii) Meaningful environments support autonomy and restore a sense of normality, and (iv) Wired to be social. Whilst limited therapy, social opportunities and having "nothing to do" were common experiences, those individuals who felt in control and responsible for driving their own stroke recovery tended to report less boredom during their rehabilitation stay. CONCLUSION: Creating rehabilitation environments that support autonomy, socialisation and opportunities to participate in activity are clear targets to reduce boredom during non-therapy time, increase meaningful engagement and possibly improve rehabilitation outcomes post-stroke.

Stroke survivors with a low sense of autonomy are at greater risk of boredom and may benefit from person-centred strategies to support participation in meaningful activities during non-therapy time whilst undertaking inpatient rehabilitation.Review and reduction of paternalistic practices within traditional models of care, to increase patient autonomy, may empower stroke survivors to drive their own activity and reduce boredom.The redesign and reorganisation of rehabilitation environments to increase opportunities for socialisation and access to nature and the outdoors may reduce boredom during inpatient rehabilitation.

The role of the physical environment in stroke recovery: Evidence-based design principles from a mixed-methods multiple case study.

Hospital design can impact patient outcomes, but there is very little healthcare design evidence specific to stroke rehabilitation facilities. Our aim was to explore, from the patient perspective, the role of the physical environment in factors crucial to stroke recovery, namely, stroke survivor activity (physical, cognitive, social), sleep, emotional well-being, and safety. We conducted a mixed-methods multiple-case study at two inpatient rehabilitation facilities in Victoria, Australia, (n = 20 at Case 1, n = 16 at Case 2) using "walk-through" semi-structured interviews, behavioural mapping, questionnaires, and retrospective audit. Four interrelated themes emerged: 1) entrapment and escape; 2) power, dependency, and identity in an institutional environment; 3) the rehabilitation facility is a shared space; and 4) the environment should be legible and patient-centred. Quantitative data revealed patterns in patient activity; stroke survivors spent over 75% of their time in bedrooms and were often inactive. Convergent mixed methods analysis was used to generate a new conceptual model of the role of the physical environment in stroke survivors' behaviour and well-being, highlighting the importance of variety and interest, privacy without isolation, and patient-centred design. This model can be used by designers, healthcare providers, and policy makers to inform the design of rehabilitation environments.

Impact assessment of the Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery.

BACKGROUND: Research impact is an emerging measure of research achievement alongside traditional academic outputs such as publications. We present the results of applying the Framework to Assess the Impact from Translational health research (FAIT) to the Centre for Research Excellence (CRE) in Stroke Rehabilitation and Brain Recovery (CRE-Stroke, 2014-2019) and report on the feasibility and lessons from the application of FAIT to a CRE rather than a discrete research project. METHODS: Data were gathered via online surveys, in-depth interviews, document analysis and review of relevant websites/databases to report on the three major FAIT methods: the modified Payback Framework, an assessment of costs against monetized consequences, and a narrative account of the impact generated from CRE-Stroke activities. FAIT was applied during the last 4 years of CRE-Stroke operation. RESULTS: With an economic investment of AU$ 3.9 million over 5 years, CRE-Stroke delivered a return on investment that included AU$ 18.8 million in leveraged grants, fellowships and consultancies. Collectively, CRE-Stroke members produced 354 publications that were accessed 470,000 times and cited over 7220 times. CRE-Stroke supported 26 PhDs, 39 postdocs and seven novice clinician researchers. There were 59 capacity-building events benefiting 744 individuals including policy-makers and consumers. CRE-Stroke created research infrastructure (including a research register of stroke survivors and a brain biobank), and its global leadership produced international consensus recommendations to influence the stroke research landscape worldwide. Members contributed to the Australian Living Stroke Guidelines: four researchers' outputs were directly referenced. Based only on the consequences that could be monetized, CRE-Stroke returned AU$ 4.82 for every dollar invested in the CRE. CONCLUSION: This case example in the developing field of impact assessment illustrates how researchers can use evidence to demonstrate and report the impact of and returns on research investment. The prospective application of FAIT by a dedicated research impact team demonstrated impact in broad categories of knowledge-gain, capacity-building, new infrastructure, input to policy and economic benefits. The methods can be used by other research teams to provide comprehensive evidence to governments and other research funders about what has been generated from their research investment but requires dedicated resources to complete.

Early Mobilization Post Acute Stroke Thrombolysis and/or Thrombectomy Survey.

Background: We sought to determine mobilization practices following emergency stroke therapy in centers across the United States. Methods: We surveyed hospitals in the NIH StrokeNet regarding mobilization practices following acute stroke thrombolysis and/or thrombectomy. An anonymous survey was sent out to all StrokeNet sites Survey questions included stroke center designation, location of admission, whether a formal bed rest protocol was in place, minimum bed rest period required, which person first mobilized the patient. Results: 48 centers responded to the survey including 45 Comprehensive Stroke Centers and 3 Primary Stroke Centers. Most patients were admitted to a neuro-intensive care unit (54%), others to a general medical/surgical ICU, stroke ward, or combination. 60% of respondents indicated that a formal bed rest policy was in place. Minimum bed rest requirements after thrombolysis alone ranged from 0 to 24 hours (35% with a 24-hour bed rest protocol, 19% with no minimum, 13% with a 12-hour minimum, 4% with an 8-hour minimum, 4% with a 6-hour minimum, and 6% with a variable rest period). Similar variations were reported in patients undergoing thrombectomy with ranges from 0 to 24 hours bed rest. First mobilization was by a nurse 52% of the time and by a physical therapist 48% of the time. Conclusions: Mobilization practices following emergency ischemic stroke reperfusion treatments vary significantly across stroke centers. Mobilization of patients is performed primarily by nurses and therapists. Further study regarding an optimal approach for mobilization following acute ischemic stroke thrombolysis and/or thrombectomy is warranted.