In patients with low-to-moderate thromboembolic risk, 1-year stroke incidence was lower than the 2% threshold for guideline-recommended anticoagulation.
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CT Perfusion for Predicting Ischemic Stroke in Patients With Symptomatic Carotid or Middle Cerebral Artery Occlusion: A Post Hoc Analysis of the CMOSS Study
Stroke, Ahead of Print. BACKGROUND:It is unknown whether computed tomographic perfusion (CTP) parameters predict ischemic stroke in patients with symptomatic chronic carotid or middle cerebral artery occlusion.METHODS:A post hoc analysis of medically treated patients enrolled in the CMOSS trial (Carotid or Middle Cerebral Artery Occlusion Surgery Study; REGISTRATION: URL:https://www.clinicaltrials.gov; Unique identifier: NCT01758614), a randomized controlled trial conducted at 13 centers in China between June 2013 and March 2018. It aimed to compare extracranial-intracranial bypass surgery to medical therapy in patients with symptomatic carotid or middle cerebral artery occlusion and hemodynamic insufficiency. CTP-derived mean transit time and relative cerebral blood flow were collected. The primary outcome was defined as ischemic stroke in the territory of the qualifying artery within 2 years after randomization. The predictive value of CTP for the primary outcome was analyzed by a Cox regression model. Receiver operating characteristic curves were used to calculate optimal cutoff values of CTP parameters.RESULTS:All 165 per-protocol patients (median age=53.7 years, 81.2% males) treated with medical treatment alone were analyzed. Sixteen (9.7%) patients suffered the primary outcome during the 2-year follow-up. Cutoff values of mean transit time >6.5 seconds (symptomatic side) and relative cerebral blood flow ≤0.5 were associated with recurrent stroke. In multivariate Cox regression, mean transit time (adjusted hazard ratio, 3.50 [95% CI, 1.19–10.30];P=0.02) and relative cerebral blood flow (adjusted hazard ratio, 7.36 [95% CI, 2.27–23.85];P=0.001) were independently associated with the primary outcome.CONCLUSIONS:CTP-based hemodynamic parameters are predictive of recurrent ischemic stroke in symptomatic patients with chronic carotid or middle cerebral artery occlusion. CTP could be used in patient selection for stratified secondary prevention of stroke in future studies.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT01758614.
Arterial, Venous, and Cerebrospinal Fluid Flow and Pulsatility in Stroke-Related Cerebral Small Vessel Disease: A Longitudinal Analysis
Stroke, Ahead of Print. BACKGROUND:Cerebral small vessel disease (SVD) causes up to 45% of dementias and 25% of ischemic strokes, but the understanding of vascular pathophysiology is limited. We aimed to investigate the contribution of pulsatility of intracranial arteries, veins, and cerebrospinal fluid (CSF) and cerebral blood flow to long-term imaging and clinical outcomes in SVD.METHODS:We prospectively recruited participants in Edinburgh/Lothian, Scotland, with lacunar or nonlacunar ischemic stroke (modified Rankin Scale score ≤2, as controls) and assessed medical and brain magnetic resonance imaging characteristics at baseline and 1 year (2018–2022). We used phase-contrast magnetic resonance imaging to measure flow and pulsatility in major cerebral vessels and CSF to investigate independent associations with baseline white matter hyperintensity (WMH) and perivascular space (PVS) volumes and their progression, as well as with recurrent stroke, functional, and cognitive outcomes at 1 year. We applied linear, logistic, and ordinal regression models in our analysis.RESULTS:We recruited 210 participants; 205 (66.8% male; aged 66.4±11.1 years) had useable data. In covariate-adjusted analyses, higher baseline arterial pulsatility was associated with larger volumes of baseline WMH (B=0.26 [95% CI, 0.08–0.44];P=0.01) and basal ganglia PVS (B=0.12 [95% CI, 0.04–0.20];P
Modulating verticality representation and uprightness by virtual reality: rationale and protocol for a within-person randomised intervention associating a basic study in healthy individuals and a pilot clinical trial in individuals exhibiting post-stroke lateropulsion (VIRGIL)
Introduction
Balance and gait disorders represent the most frequent and disabling sequelae after stroke. Impaired body orientation with respect to gravity (lateropulsion) is one of the primary underlying mechanisms, increasingly investigated. After hemisphere stroke, lateropulsion is caused by an impaired internal representation of verticality, for which developing rehabilitation techniques has become a priority. Among various approaches, virtual reality appears to be a promising tool for modulating spatial reference frame. The objective of this study is to investigate the effects of immersion in virtual tilted reality (VTR) on the postural vertical (PV) as a primary outcome, as well as main secondary outcomes on the visual vertical (VV) and the active standing posture (body orientation with respect to gravity and weight-bearing (WB) distribution on lower limbs), both in healthy individuals and individuals exhibiting lateropulsion at the subacute phase after a hemispheric stroke. The cumulative effect of the VTR on the post-stroke lateropulsion will also be analysed.
Methods and analysis
This pilot study is a single-centre, within-person randomised trial conducted in the department of Physical and Rehabilitation Medicine of the University Hospital of Grenoble-Alpes (France). We will include 40 individuals from 18 to 85 years old, 20 healthy individuals and 20 individuals with lateropulsion tested 0.5 on the Scale for Contraversive Pushing), the study lasts 4 weeks: W1 for inclusion, randomisation, planning and conventional rehabilitation; W2 and W4 to collect clinical data and conventional rehabilitation; and W3 for the VTR intervention over four consecutive mornings at the same time: 2 to test the VTR effects on verticality perception (PV and VV) and 2 to test the VTR effects on active standing (body orientation and WB distribution on lower limbs). Immediate effects and post-effects of the VTR immersion are analysed by comparing results of the following time points: for verticality perception baseline, during and after VTR and for active standing at only baseline and during VTR immersion. Linear mixed-effect models will be run with different factors/covariates according to objectives. We will analyse the proportion and features of responders (PV modulation ≥2°). The cumulative effect of the 4 days of VTR sessions will be analysed by comparing scores of the SCAle for LAteropulsion assessed at the end of every week.
Ethics and dissemination
The study was approved by an institutional review board at the national level (Comité de Protection des Personnes Ile de France X; 2020-A02941-38, amendment 2024). All participants will provide written informed consent before enrolment. Findings will be submitted to peer-reviewed journals related to rehabilitation, stroke or neuroscience.
Trial registration number
ClinicalTrials.gov, NCT04911738.
Current status and prognostic factors of paediatric arterial ischaemic stroke in China: a study protocol for Chinese Paediatric Ischaemic Stroke Registry (CPISR)
Introduction
The treatment of paediatric AIS is particularly challenging due to its rarity, limited clinical awareness and absence of targeted treatment protocols and evidence-based data. This study aims to address these gaps by investigating the epidemiology, risk factors, aetiology and treatment of stroke in children in China and to observe the short-term and long-term functional outcomes of paediatric stroke and explore the factors that influence outcomes.
Method and analysis
The Chinese Paediatric Ischaemic Stroke Registry (CPISR) is a multicentre, prospective observational study that plans to consecutively recruit patients at 85 centres across 20 provinces in China. To streamline data collection, a WeChat-based programme has been developed to allow participating institutions to input standardised questionnaire data directly and upload electronic medical records. Comprehensive demographic, clinical, neuroimaging and laboratory data are collected and tracked for registered patients. All patients undergo detailed assessment at the time of admission and during scheduled follow-up visits.
Ethics and dissemination
Ethical approval has been obtained from the Ethics Committee of the First Affiliated Hospital of University of Science and Technology of China (2022KY071). The findings of this study will be disseminated through peer-reviewed journals, national and international conference presentations and reports to participating institutions and relevant stakeholders.
Trial registration number
ChiCTR2200059915.
Correction: Differences in acute ischaemic stroke inhospital mortality across referral stroke hospitals in Spain: a retrospective, longitudinal observational study
Estupiñán-Romero F, Pinilla Dominguez J, BernalDelgado E, et al. Differences in acute ischaemic stroke inhospital mortality across referral stroke hospitals in Spain: a retrospective, longitudinal observational study. BMJ Open 2023;13:e068183. doi:10.1136/ bmjopen-2022-068183. This article has been corrected since it was published online. The funding statement has been updated from ‘This study was partially funded by grants from CONCEPT-STROKE: Effectiveness and efficiency of acute ischaemic stroke care pathways in five Spanish Regions (PI19/00154); REDISSEC: Red de Investigación en Servicios de Salud en Enfermedades Crónicas (RD16/0001/0007); and RICCAPS: Red de Investigación en cronicidad, atención primaria y promoción de la salud (RD21/0016/0023).’ to ‘This study was partially funded through the projects CONCEPT-STROKE: Effectiveness and efficiency of acute ischaemic stroke care pathways in five Spanish Regions (PI19/00154) REDISSEC: Red de Investigación en Servicios de Salud en Enfermedades Crónicas (RD16/0001/0007) and RICCAPS: Red de Investigación en cronicidad, atención primaria y promoción de la salud…
Does Tenecteplase Before Thrombectomy Benefit Patients with Large-Vessel Occlusion Stroke?
Tenecteplase pretreatment improved outcomes in patients treated within 4.5 hours.
Compensatory Proximal Adjustments Characterize Effective Reaching Movements After Stroke
Stroke, Ahead of Print. BACKGROUND:Understanding of sensorimotor reorganization following a stroke is still incomplete. This study examined how the neuromotor system of well-recovered patients with stroke achieves stable control of the redundant degrees of freedom in the upper limb through goal-directed reaching movements.METHODS:Thirteen right-handed individuals with left-hemispheric stroke and 13 age-, sex- and handedness-matched healthy controls participated in this cross-sectional study. Each participant performed 80 unconstrained reach-to-grasp movements with either arm while kinematic data were recorded at 200 Hz using an optoelectronic motion capture system. Two types of outcome measures were examined, contrasting healthy individuals with those who have had strokes: end point and proximal kinematics. End point kinematics analyzed spatiotemporal hand movement characteristics, including movement time, time-to-peak velocity (TTPVHD), time-to-peak acceleration (TTPAHD), and velocity peaks for trajectory smoothness. Proximal kinematics focused on interjoint and intrajoint coordination of the elbow and shoulder, examining angular velocities and their timing differences. Stroke effects were analyzed using linear mixed-effects models.RESULTS:No significant differences were observed in distal end point kinematics between groups (n=13 each) for movement time (control versus stroke, 0.92 versus 0.96 s;P=0.944), TTPVHD(40% versus 42% of movement time,P=0.358), TTPAHD(22% versus 21%;P=0.583), or smoothness (1.02 versus 1.15;P=0.057). However, stroke significantly affected proximal kinematics, altering interjoint coordination with differences in timing between elbow flexion and shoulder rotation (18% versus 14%;P=0.019) and intrajoint coordination with differences in timing between shoulder flexion and abduction (18% versus 11%;P=0.008) and between flexion and rotation (1% versus 10%;P=0.001).CONCLUSIONS:Arm motor control in this cohort of well-recovered patients with stroke showed near-complete restoration of distal end point kinematics but significant differences in the timing of proximal intrajoint and interjoint coordination. These findings suggest compensatory adjustments in shoulder and elbow movements to achieve functional goals like reaching. An enhanced understanding of these strategies can inform targeted interventions to improve upper limb capability poststroke.
Structural Brain Plasticity in Chronic Stroke: Cerebellar Remodeling and Its Association With Upper Limb Motor Outcome
Stroke, Ahead of Print. BACKGROUND:Neuronal plasticity after stroke occurs predominantly within the first few months. However, its persistence and distribution in the chronic phase remain unclear. This study investigated longitudinal changes in cortical gray matter and corticospinal tract integrity beyond 6 months poststroke and their associations with chronic upper limb motor outcomes.METHODS:We conducted a retrospective cohort study at St. Vincent’s Hospital (Suwon, Republic of Korea) between 2015 and 2022, including patients with first-ever unilateral stroke who underwent at least 2 magnetic resonance imaging scans ≥6 months post-onset. Gray matter volume in cerebral and cerebellar cortices was assessed using 3-dimensional T1-weighted imaging and corticospinal tract integrity via diffusion tensor tractography. Hemispheres were classified as affected or unaffected based on anatomic connectivity to the lesion. Upper limb motor score was measured using a 5-stage ordinal scale and grouped into 3 categories by hand function: poor (no movement), partial (limited movement), and good (fully functional use). Ordinal logistic regression identified structural predictors of motor outcomes, adjusting for age, sex, lesion volume, and baseline impairment.RESULTS:Among 62 patients, structural plasticity persisted beyond 6 months in a subset of patients. Imaging was conducted at an average of 51 months poststroke (range, 13–137 months). Increases in affected cerebellar gray matter were associated with better motor outcomes (odds ratio, 0.67 [95% CI, 0.48–0.92];P=0.01). The odds ratio
Intracerebral Delivery of rhFGF20 via Heparin-Poloxamer Hydrogel Promotes Neurological Recovery in Ischemic Stroke
Stroke, Ahead of Print. BACKGROUND:Ischemic stroke poses a significant threat to human health. FGF (fibroblast growth factor) 20 is involved in the repair of central nervous system diseases, but it has the shortcomings of short half-life and inability to penetrate the blood-brain barrier. Therefore, to overcome the drawbacks of rhFGF20 (recombinant human FGF20) and explore its role in ischemic stroke, the effects of intracerebral administration of rhFGF20 by heparin-poloxamer hydrogel (HP-rhFGF20 [heparin-poloxamer hydrogel-encapsulated rhFGF20]) in a rat stroke model were the focus of this study.METHODS:A rat model of middle cerebral artery occlusion/reperfusion and oxygen-glucose deprivation-reoxygenation models were established to mimic ischemic stroke in vivo and in vitro, respectively. Endogenous FGF20 levels were measured in patients, ischemic rats, and oxygen-glucose deprivation-reoxygenation–injured neurons. To assess the therapeutic potential, rhFGF20 was administered intracerebrally via heparin-poloxamer hydrogel implants (1 mg/mL, 20 μL) on day 5 poststroke. TTC staining, neurobehavioral tests (including the mNSS test, the corner test, the rotarod test, the cylinder test, and the Morris water maze test), and Nissl staining were performed to evaluate neurological recovery. Immunofluorescence and Western blotting were conducted to assess the brain repair processes (neurogenesis, neuronal remodeling, and angiogenesis).RESULTS:High expression of FGF20 was detected in the serum of patients with ischemic stroke, the cortex of ischemic rats, and oxygen-glucose deprivation-reoxygenation–injured neurons. Heparin-poloxamer increased the stability and bioavailability of rhFGF20. HP-rhFGF20 attenuated neurobehavioral deficits and infarct volume in ischemic stroke rats. HP-rhFGF20 inhibited neuronal cell death, microglial activation, and glial scar formation on day 7 post-implantation. Moreover, HP-rhFGF20 promoted the proliferation, migration, and differentiation of neural stem cells and improved neuronal plasticity and angiogenesis in ischemic stroke rats.CONCLUSIONS:HP-rhFGF20 promoted functional recovery in ischemic stroke rats by enhancing neurogenesis and angiogenesis. The combination of growth factors and biomaterials provides a promising therapeutic strategy for central nervous system diseases.REGISTRATION:URL:http://www.chictr.org.cn; Unique identifier: ChiCTR2100051104.
Rare Variant Association Analysis Uncovers Involvement of VNN2 in Stroke Outcome
Stroke, Ahead of Print. BACKGROUND:A stroke’s functional outcome presents vast variability among patients, which is influenced by age, sex, characteristics of the lesion, and genetic factors. However, there is little knowledge about stroke recovery genetics. Recently, some GWAS (Genome-Wide Association Studies) have highlighted the involvement of common or low-frequency variants near or withinPATJ,PPP1R21,PTCH1,NTN4, andTEK genes, whereas the role of rare variants is still unclear. This study aims to identify the genetic contributions to differences in stroke outcomes by analyzing the effect of rare variants.METHODS:We performed a pilot study analyzing 90 exomes of extreme good and bad recovery (modified Rankin Scale score at 3 months, 0–1 versus 4–5) to select target genes involved in stroke recovery. To expand this study, 702 additional samples were sequenced by targeted next-generation sequencing capturing loci selected from the pilot study, GWASs, and literature input. Here, we performed continuous (modified Rankin Scale score, 0–6) and dichotomous (modified Rankin Scale score, 0–1 versus 3–6) analyses, yielding 1 candidate gene. All samples were selected by a retrospective cohort study from incidental stroke cases collected at Spanish Hospitals between 2000 and 2018. The identifiedVNN2variants were assessed for protein structure and stability analysis, and an analysis of their effect on basal inflammation levels was performed using UK Biobank data.RESULTS:Our work identified rare coding variants inVNN2associated with patients with better stroke recovery (∆ deviance information criterion >10, equivalent toP1.6 kcal/mol); meanwhile, another variant, located in the active site, could affect the electrostatic surface.CONCLUSIONS:We propose thatVNN2might play a role in stroke outcomes by modulating poststroke inflammation. A potentially affected function would be neutrophil cell adhesion and migration.
Automated Vessel Occlusion Software in Acute Ischemic Stroke: Pearls and Pitfalls
Stroke, Ahead of Print. Software programs leveraging artificial intelligence to detect vessel occlusions are now widely available to aid in stroke triage. Given their proprietary use, there is a surprising lack of information regarding how the software works, who is using the software, and their performance in an unbiased real-world setting. In this educational review of automated vessel occlusion software, we discuss emerging evidence of their utility, underlying algorithms, real-world diagnostic performance, and limitations. The intended audience includes specialists in stroke care in neurology, emergency medicine, radiology, and neurosurgery. Practical tips for onboarding and utilization of this technology are provided based on the multidisciplinary experience of the authorship team.
Tertiary prevention interventions for patients with stroke in African countries: a systematic review
Objectives
To summarise the best available evidence on tertiary prevention interventions for patients with stroke conducted in African countries, identify the gaps in stroke prevention research and augment efforts to establish stroke rehabilitation guidelines in African countries.
Design
We performed a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement on the basis of a published protocol.
Data sources
We conducted a systematic search of nine electronic databases, including PubMed, the Cochrane Library and African Index Medicus, published until August 2023 and additionally contacted authors and screened reference lists.
Eligibility criteria
We included randomised controlled trials (RCTs) and prospective cohort studies on African adult patients with a clinical diagnosis of stroke. The primary outcome was global disability, and secondary outcomes were neurologic function scales.
Data extraction and synthesis
Two authors independently screened the search results, with data extracted by one author and verified by a second author. The data were narratively synthesised. A meta-analysis was done using a random-effects model for metric data using standardised mean differences. Risk of bias was assessed using the Cochrane Risk of Bias tool.
Results
Of 3305 publications, 25 studies met the inclusion criteria involving cumulatively 973 patients with subacute and chronic stroke. Two-thirds of the trials were conducted in Nigeria and Egypt. The interventions covered physiotherapeutic, electrophysiologic, psychotherapeutic and transitional care domains with mostly beneficial outcomes. All included studies were RCTs with some concerns about methodologic quality.
Conclusion
This systematic review comprises heterogeneous effective interventions for tertiary stroke prevention mostly conducted in small productive research clusters. There is a growing body of research from African countries covering important fields of stroke rehabilitation, including local adaptations of the rehabilitation process and new knowledge concerning transcranial magnetic stimulation. There remains an urgent need to implement interventions aimed at overcoming barriers to stroke rehabilitation.
PROSPERO registration number
CRD42020159125.
External validation of risk prediction models for post-stroke mortality in Berlin
Objectives
Prediction models for post-stroke mortality can support medical decision-making. Although numerous models have been developed, external validation studies determining the models’ transportability beyond the original settings are lacking. We aimed to assess the performance of two prediction models for post-stroke mortality in Berlin, Germany.
Design
We used data from the Berlin-SPecific Acute Treatment in Ischaemic or hAemorrhagic stroke with Long-term follow-up (B-SPATIAL) registry.
Setting
Multicentre stroke registry in Berlin, Germany.
Participants
Adult patients admitted within 6 hours after symptom onset and with a 10th revision of the International Classification of Diseases discharge diagnosis of ischaemic stroke, haemorrhagic stroke or transient ischaemic attack at one of 15 hospitals with stroke units between 1 January 2016 and 31 January 2021.
Primary outcome measures
We evaluated calibration (calibration-in-the-large, intercept, slope and plot) and discrimination performance (c-statistic) of Bray et al’s 30-day mortality and Smith et al’s in-hospital mortality prediction models. Information on mortality was supplemented by Berlin city registration office records.
Results
For the validation of Bray et al’s model, we included 7879 patients (mean age 75; 55.0% men). We observed 763 (9.7%) deaths within 30 days of stroke compared with 680 (8.6%) predicted. The model’s c-statistic was 0.865 (95% CI: 0.851 to 0.879). For Smith et al’s model, we performed the validation among 1931 patients (mean age 75; 56.2% men), observing 105 (5.4%) in-hospital deaths compared with the 92 (4.8%) predicted. The c-statistic was 0.891 (95% CI: 0.864 to 0.918). The calibration plots of both models revealed an underestimation of the mortality risk for high-risk patients.
Conclusions
Among Berlin stroke patients, both models showed good calibration performance for low and medium-risk patients and high discrimination while underestimating risk among high-risk patients. The acceptable performance of Bray et al’s model in Berlin illustrates how a small number of routinely collected variables can be sufficient for valid prediction of post-stroke mortality.
Prevalence and factors influencing fear of disease progression in stroke patients: a systematic review and meta-analysis with a focus on China
Objectives
To systematically estimate the prevalence and influencing factors of fear of disease progression (FoP) in patients who had a stroke, with a focus on China.
Design
Systematic review and meta-analysis of observational clinical studies.
Data sources
Eight databases (China National Knowledge Infrastructure, Wanfang Database, Chinese Scientific Journal Database (VIP), CBM, Web of Science, PubMed, Cochrane Library, Embase) were searched from inception to March 2024, supplemented by manual reference screening.
Eligibility criteria
Cross-sectional studies reporting FoP incidence or influencing factors in Chinese stroke patients using the Fear of Progression Questionnaire-Short Form scale were included.
Data extraction and synthesis
Two reviewers independently screened studies, extracted data and assessed study quality using the Agency for Healthcare Research and Quality tool (score range: 0–11 points). Random-effects models were applied to address substantial heterogeneity. Stata 17.0 software was used for meta-analysis.
Results
A total of 20 studies (15 medium-quality, 5 high-quality) involving 7156 patients were included. The pooled incidence of FoP in Chinese stroke patients was 56% (95% CI=45% to 66%), derived from a random-effects model despite significant between-study heterogeneity (I²= 98.7%), with subgroup analyses and leave-one-out sensitivity analysis confirming result robustness. Subgroup analysis revealed that the incidence was highest in East China (70%, 95% CI=56% to 83%), followed by Central China (55%, 95% CI=36% to 73%) and North China (43%, 95% CI=38% to 47%). The incidence of FoP in haemorrhagic stroke (72%, 95% CI=49% to 95%) was higher than that in ischaemic stroke (45%, 95% CI=27% to 64%). The incidence of FoP after 2020 (59%, 95% CI=48% to 70%) was higher than that before 2020 (40%, 95% CI=32% to 47%). Meta-regression identified publication year (p=0.004) and research region (p=0.001) as key heterogeneity sources. The main influencing factors of FoP in Chinese stroke patients included age (OR=0.94, 95% CI=0.92 to 0.97, p
Secondary prevention by striking the balance in 24-hour movement behaviour by empowering people at risk with a stroke: rationale and design of the RISE intervention randomised controlled trial
Introduction
Striking the balance in 24-hour movement behaviour (sedentary behaviour, physical activity and sleep) is expected to reduce the risk of a new major cardiovascular event or death (MACE). We aim to determine the effectiveness and cost-effectiveness of the RISE (Reduce and Interrupt sedentary behaviour using a blended behavioural intervention to Empower people at risk towards sustainable 24-hour movement behaviour change) intervention by improving 24-hour movement behaviour for prevention of MACE and gaining quality-adjusted life years (QALYs) in community-dwelling people at risk with a first-ever stroke.
Methods and analysis
This assessor-blinded multicentre randomised controlled trial includes about 1000 participants with a first-ever stroke, of which 752 participants require secondary prevention based on their 24-hour movement behaviour. Participants will be randomly assigned to the experimental group (RISE intervention + usual care) or control (usual care) group. RISE is a 15-week blended care intervention: primary care physiotherapists coach people in their home setting using behaviour change techniques and the RISE eCoaching system. This system consists of: (1) an activity monitor, (2) a smartphone application that provides real-time feedback and contains e-learning modules and (3) a monitoring dashboard for the physiotherapist. A close relative of the participant is involved during the intervention to provide social support. The primary outcome is the effectiveness of the RISE intervention regarding the prevention of MACE measured at one year post randomisation using survival analysis comparing the experimental and control groups. Secondary outcomes include cost-effectiveness for MACE prevention and QALYs and changes in 24-hour movement behaviour over time using compositional data analysis.
Ethics and dissemination
Ethical approval is obtained from Medical Ethics Review Committee Utrecht, NedMec NL83940.000.23. Findings will be disseminated through international peer-reviewed journals and conferences. A sustainable 24-hour movement behaviour change is needed to gain long-term benefits of lowering MACE in patients with stroke. The RISE intervention offers this foundation by integrating behaviour change techniques, the RISE eCoaching system, involvement of participatory support and extensively trained RISE physiotherapists. Consequently, the RISE intervention is expected to be (cost-)effective compared with usual care, and hence, this study will offer a foundation for implementing the RISE intervention in standard poststroke care.
Trial registration number
NCT06124248.