Search Results for: Passo 12. Ripulire in modo mirato le cartelle cliniche degli assisiti

Objectives
A consensus study to establish a Core Outcome Set for dysarthria after stroke identified four key outcome domains that should be measured in research and clinical practice: (1) intelligibility of speech, (2) ability to participate in conversations, (3) living well with dysarthria and (4) communication partners skills and knowledge (where relevant). This review aimed to systematically identify corresponding measurement instruments and to examine their clinical utility and psychometric properties.

Design
Systematic review conducted in alignment with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources
CINAHL, EMBASE, MEDLINE, PsycInfo and Cochrane Stroke Group Trials Register, CENTRAL, Linguistics and Language Behavioral Abstracts (LLBA). Major trials registers: WHO ICTRP, ISRCTN registry and ClinicalTrials.gov searched March 2024.

Eligibility criteria for selecting studies
We included trials that developed or used measurement instruments for poststroke dysarthria. We identified studies that could be included in an update of the Cochrane systematic review of interventions for non-progressive dysarthria to identify what measurement instruments were used in therapy trials for poststroke dysarthria.

Data extraction and synthesis
Records were screened independently by three authors. Psychometric data were extracted, by two authors, from included studies and methodological quality was evaluated using Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) and Core Outcome Measures in Effectiveness Trials (COMET) guidance. Assessment of clinical utility followed Outcome Measures in Rheumatology (OMERACT) guidance.

Results
Following screening, 19 publications reporting 12 measurement instruments were identified. According to COSMIN standards, all 19 publications were rated as having low, very low or unknown quality of evidence. Three measurement instruments were identified as having the most relevant clinical utility to the population, the highest quality of evidence and had the potential to measure some specific aspects from three of the four agreed domains, intelligibility, conversations and living well with dysarthria from the patient and clinician perspective. These were the Frenchay Dysarthria Assessment II, the Communication Outcomes After Stroke Scale and the Therapy Outcome Measures for Dysarthria.

Conclusions
This review provides a comprehensive overview and appraisal of dysarthria measurement instruments to align with a Core Outcome Set. We only included English language-based measurement instruments. Many dysarthria measurement instruments were developed for non-stroke populations, including progressive dysarthria, with limited psychometric data for stroke. Measurement instruments with uncertain quality of evidence can still be considered for inclusion with a Core Outcome Set and three have been suggested. There is a need for further psychometric testing of these and the development of new measurement instruments to cover all aspects of intelligibility, conversations, living well with dysarthria and communication partner skills.

PROSPERO registration number
CRD42022302998.

Introduction
Sarcopenia and frailty have been identified as negative predictors of health outcomes. Patients with stroke, traumatic brain injury (TBI), knee osteoarthritis (OA) and breast cancer commonly experience low physical activity levels in the chronic phase of recovery. This prospective study aims to explore the feasibility of multimodal screening and longitudinal tracking of various biomarkers from the acute to chronic phase of disease to determine the relationship with frailty outcomes.

Methods and analysis
A prospective longitudinal observational cohort study involving Asian populations is planned over 3 years. Enrolled participants with index conditions of acute stroke, TBI, knee OA and breast cancer will be recruited from rehabilitation hospitals and clinics and followed longitudinally. Reference thresholds from the Asian Working Group on Sarcopenia will be used. Variables include self-reported questionnaires, disease and comorbidity characteristics, anthropometric measurements, appetite questionnaires, muscle ultrasound (MUS), muscle/bone mass, blood biomarkers and markerless gait motion systems. In particular, physical performance (short physical performance battery and hand grip strength), sarcopenia (SARC-F questionnaire) and frailty assessment (FRAIL score, clinical frailty scale), four-region MUS, body composition analysis, dual X-ray absorptiometry, bone mineral densitometry, physical activity levels (International Physical Activity Questionnaire for the elderly [IPAQ-E], fitness trackers) and health-related quality of life assessment (EuroQoL-5D questionnaire five level [EQ5D-5L]) will be used. Blood biomarkers measuring metabolic health (eg, glycated haemoglobin, cholesterol, fasting glucose and 25-OH vitamin D) and inflammation (eg, Tumor Necrosis Factor-alpha [TNF-α] and Monocyte Chemoattractant Protein-1 [MCP-1]) will be measured at baseline. Data collection will take place at postrecruitment baseline (hospital admission), 1, 6 months, 12 months and 2 years postrecruitment (inpatient) and at postrecruitment baseline, 6 months, 12 months and 2 years postrecruitment (outpatient).

Ethics and dissemination
Ethical approval has been obtained from the National Healthcare Group Domain Specific Review Board (2023/00105). Findings will be disseminated through conference presentations and publication in scientific journals.

Trial registeration number
NCT06073106.

Objective
To evaluate the burden of asthma in five European countries (5EU; France, Germany, Italy, Spain and United Kingdom [UK]).

Design
A retrospective cross-sectional study was conducted based on the data from the 2018 National Health and Wellness Survey. Health-related quality of life (HRQoL), work productivity and activity impairment, and healthcare resource utilisation (HCRU) were compared between different groups: asthma versus non-asthma, mild/moderate/severe asthma versus non-asthma and moderate/severe asthma versus mild asthma.

Settings
Internet-based survey across Western Europe.

Participants
Adult patients (aged ≥18 years) with self-reported physician diagnosis of asthma and experienced asthma symptoms in the past 12 months.

Outcome measures
Socio-demographic characteristics, asthma-related outcomes, HRQoL and productivity, HCRU and prevalence of asthma.

Results
The prevalence of asthma in the 5EU was 6.7% (95% CI: 6.5% to 6.9%), with the UK reporting the highest rates (10.4%; 95% CI: 9.9% to 10.9%). About 52.0% of the respondents had mild asthma, 27.9% had moderate and 20.1% had severe asthma. The asthma group reported significantly poorer HRQoL, higher rates of overall work productivity impairment and activity impairment, and a greater number of visits to emergency room, healthcare provider and hospitalisations versus the non-asthma group (all p

Introduction
Sensorimotor training (SoMT) is a gradual balance training technique employed to treat various chronic musculoskeletal pain. Core strength training (CST) is one of the most commonly used interventions for managing low back pain (LBP). This randomied controlled trial protocol aims to determine whether the combination of SoMT and CST can significantly reduce LBP, and improve scoliosis-related outcomes and overall functional status in adult idiopathic scoliosis (AdIS) patients.

Methods and analysis
A total of 300 AdIS patients will be recruited from the outpatient clinic and randomly assigned to one of three groups: CST group, SoMT group or the combined therapy group, using stratified block randomization based on the severity of scoliosis curve. All groups will receive the intervention three times a week for 12 weeks. Sessions will be conducted in the hospital, and no home programme will be provided. Adherence and attendance will be monitored and recorded. The CST group will receive CST therapy, while the SoMT group will receive SoMT therapy, which consists of three progressive phases: static, dynamic and functional. Participants will progress to the next phase on achieving pelvic stability in the current phase. The combined therapy group will receive both CST and SoMT. Assessors and statisticians will remain blinded to participant allocation throughout the study. Assessments will be performed at baseline and at the endpoint, 12 weeks after the initiation of the intervention. The primary outcome will be the self-reported pain level, measured using the visual analogue scale. Secondary outcomes will include pain-related disability (by the Oswestry Disability Index and the Roland-Morris Disability Questionnaire), spinal morphology indicators (including Cobb angle, the angle of trunk rotation and the Sagittal Index), postural control ability (by the Tetrax IBSTM), proprioceptive sensitivity (by the repositioning error test) and health-related quality of life (by the 36-Item Short Form Health Survey). Statistical analysis will adhere to the intention-to-treat principle and will be complemented by per-protocol analysis. To compare the effects of SoMT versus CST and combined therapy versus SoMT on both primary and secondary outcomes, a linear mixed-effects model or generalised linear mixed model will be applied.

Ethics and dissemination
The current study received ethical approval from the Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiao Tong University School of Medicine (XHEC-C-2024-080-3). Written informed consent will be obtained from all participants. Any interim analysis and full results will be published in an international peer-reviewed journal.

Trial registration number
This protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2400085370).

Introduction
The capacity of a health system to fulfill the justifiable demands of patients and their caregivers while delivering prompt, courteous and patient-centered treatment is known as health system responsiveness (HSR). HSR can be considered as a measure for the quality of the health system. Keeping aside the clinical aspects of healthcare, it focusses on the health system’s capacity to meet the needs of patients in accordance with ethical values and service standards. HSR is comprised of eight major dimensions including autonomy, dignity, confidentiality, timely attention, communication, facility quality, social support network accessibility and provider choice.

Methods and analysis
An analytical cross-sectional study will be conducted in three public anti-retroviral therapy (ART) centres of Karachi, Pakistan, and will continue for a period of 12 months using purposive sampling technique. A sample size of 381 individuals is calculated, and patients aged >18 years, on treatment for the past 12 months will be included. Face-to-face interviews will be carried out by trained interviewers after obtaining informed consent in the local language. Descriptive statistics will be presented alongside binary logistic regression analysis.

Ethics and dissemination
Written and informed consent will be taken from each participant before enrolment. This study is approved by the ethical review committee at the Aga Khan University Hospital (Ref No: 2024-9960-31694), and official permission has been obtained by the additional district health officer of the local government. We will disseminate the findings to stakeholders at the provincial government, private institutions, local and international conferences and a peer-reviewed journal.

Circulation, Ahead of Print. BACKGROUND:Desmosomal gene variants (DGVs) have been associated with a diverse spectrum of phenotypic manifestations within arrhythmogenic cardiomyopathy, but data on genotype-specific outcomes are lacking. We investigated genotype-specific arrhythmic and heart failure (HF) outcomes in DGV carriers.METHODS:This cohort study included consecutive patients referred for screening for desmosomal genes. Carriers of pathogenic and rare (allele frequency

Stroke, Ahead of Print. BACKGROUND:This study aimed to investigate neurophysiological mechanisms underlying functional impairment and recovery after acute ischemic stroke using transcranial magnetic stimulation combined with electroencephalography, focusing on interhemispheric interactions and oscillatory dynamics.METHODS:This single-center case-control study (December 2022 to May 2024) included 19 ischemic stroke patients within 14 days of symptom onset (mean age, 47.95±12.41 years; 15 [79%] males) with 3-month poststroke follow-up. Sixteen age-matched healthy controls (53.56±9.83 years; 12 [80%] males) were included. Transcranial magnetic stimulation-evoked electroencephalography potentials, local mean field power during 25 ms and 35 ms (local mean field power25–35 ms), and power spectral density of the ipsilesional primary motor cortex (ilM1) were calculated when single-pulse transcranial magnetic stimulation was sequentially applied to the contralesional M1 (clM1) and ilM1. Spearman correlation analysis evaluated associations between transcranial magnetic stimulation combined with electroencephalography parameters and clinical outcomes: Fugl-Meyer assessment, Fugl-Meyer assessment-upper extremity subscale, National Institutes of Health Stroke Scale, and National Institutes of Health Stroke Scale changes from baseline to 3 months poststroke.RESULTS:Stroke patients exhibited simplified transcranial magnetic stimulation-evoked electroencephalography potential waveforms with reduced amplitudes compared with healthy controls. The contralesional resting motor threshold of stroke patients was significantly lower compared with healthy controls (t=−2.79;P=0.009). The contralesional resting motor threshold was positively associated with the local mean field power25–35 msof ilM1 with stimulation on ilM1 (r=0.482;P=0.018). The power and power spectral density of β oscillations were negatively associated with the Fugl-Meyer assessment (r=−0.557,P=0.014;r=−0.417,P=0.038, respectively) and Fugl-Meyer assessment-upper extremity (r=−0.503,P=0.014;r=−0.389,P=0.05, respectively), but the power of β oscillations was positively associated with changes in the National Institutes of Health Stroke Scale (r=0.507;P=0.027) with stimulation on clM1.CONCLUSIONS:Increased excitability of the clM1 is associated with decreased excitability of the ilM1. The inhibition of β oscillations in the ilM1 by the clM1 serves as a biomarker for poststroke functional impairment and recovery. Neuromodulation of the clM1 to enhance the β oscillations of ilM1 may be a promising treatment strategy.

Stroke, Ahead of Print. BACKGROUND:There is uncertainty about whether patients with M2 occlusion benefit from endovascular therapy (EVT) in the late (6–24-hour) time window. We evaluated the clinical outcomes of patients with M2 occlusion selected for EVT compared with those who received medical management (MM) in the late window.METHODS:This multinational cohort study was conducted at 66 sites across 10 countries (January 2014 to May 2022). We included consecutive patients with late-window stroke due to M2 occlusion, baseline National Institutes of Health Stroke Scale score of ≥5, and premorbid modified Rankin Scale score of ≤2 who received EVT or MM alone. The primary end point was 90-day ordinal shift in the modified Rankin Scale score. Safety end points were symptomatic intracranial hemorrhage and 90-day mortality. Differences in outcomes were determined using inverse probability of treatment weighting–adjusted logistic regression models.RESULTS:Among 5098 patients, 496 met inclusion criteria (median [interquartile range] age, 74 years [62–81 years]; baseline National Institutes of Health Stroke Scale score, 12 [8–17]), of whom 394 (79.4%) received EVT and 102 (20.6%) MM. In inverse probability of treatment weighting adjusted analyses, there was no favorable 90-day ordinal modified Rankin Scale shift (odds ratio, 1.39 [95% CI, 0.92–2.12]) and no difference of functional independence rates (modified Rankin Scale score of 0–2; odds ratio, 1.72 [95% CI, 0.93–3.15]) with EVT compared with MM. Moreover, symptomatic intracranial hemorrhage risk (odds ratio, 3.46 [95% CI, 0.50–23.92]) and 90-day mortality (odds ratio, 1.11 [95% CI, 0.66–1.87]) were not statistically different between treatment groups.CONCLUSIONS:In patients with M2 occlusion in the 6- to 24-hour time window, there was no difference in disability outcomes or symptomatic intracranial hemorrhage risk between patients treated with EVT compared with MM. Results of ongoing randomized trials will provide further insight.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT04096248.

Con IA 2 settimane lavoro l’anno risparmiate per medici famiglia

Con IA 2 settimane lavoro l’anno risparmiate per medici famiglia

Introduction
The effects of bariatric surgery have largely been studied from a medical viewpoint, seeking to measure changes in anthropometric, physiological or quality-of-life factors after the operation. Few studies, however, have focused on the dynamics of lifestyle changes. Yet we know that changing lifestyle habits—which are often part of the established social configurations at the origin of morbid obesity—is essential for a sustainable recovery from obesity. We also know that the major bodily transformations that occur in the six to twelve months following surgery produce a high degree of biographical uncertainty and affect social interactions. From a sociological perspective, the authors propose to study the processes of disruption and re-establishment of lifestyle habits in the first 24 months following bariatric surgery.

Methods and analysis
The ChiBarAPS study relies on a mixed-method longitudinal survey, comprising three components: qualitative, quantitative, literature and data review. It aims to document three main dimensions, which must be articulated to understand the dynamics of change: (1) the work undertaken by patients on themselves in order to identify and measure the evolutionary effects of surgery, as well as to adapt to them; (2) the experience of using pre- and post-surgery information and support systems, and evaluating their effects on the agency of the people who have undergone surgery; (3) the evolution of social participation and lifestyle habits. The qualitative component concerns a cohort of 30 patients, interviewed in depth (2 hours) on these three dimensions, 6 months, 12 months and 24 months after the operation. The quantitative part uses questionnaires applied to a second group of 200 patients, following the same timeline.

Ethics and dissemination
This study complies with reference methodology MR004 of the French National Data Protection Authority and was registered by the Data Protection Officer of the University of Montpellier on the activity registry of the institution (24 April 2024). Ethics approval has been obtained from the University of Montpellier ethics research board (n°UM2024-037). Informed consent will be obtained from all participants before data collection. The project has received funding from the French National Research Agency (n°ANR-23-CE41-0020-01) from February 2024 to the end of January 2028. The first results of the research will be disseminated from 2026 onwards to researchers, health professionals and patient support organisations. The results of the study will then be published in peer-reviewed scientific journals, both national and international.

Introduction
Insomnia is a significant global health issue associated with substantial economic costs. International guidelines recommend cognitive behavioural therapy for insomnia (CBT-I) as the first-line treatment for chronic insomnia; however, pharmacotherapy remains more common in clinical practice. Maintaining the effectiveness while reducing the time and frequency of CBT-I is essential for its implementation. We conducted a randomised controlled trial (RCT) to evaluate the effectiveness of a brief behavioural treatment for insomnia (BBTI) that focuses on sleep restriction and stimulus control (SC)—both established as effective standalone interventions. This article presents the study protocol to examine whether adding BBTI to treatment as usual improves outcomes in patients with chronic insomnia.

Methods and analysis
We will conduct a multicentre RCT. We will randomly assign patients with chronic insomnia to two groups (BBTI vs sleep hygiene) in a 1:1 ratio. The BBTI consists of three 15 min sessions over 4 weeks delivered by healthcare professionals following a detailed manual. The primary outcome is the Insomnia Severity Index at 8 weeks. Secondary outcomes include sleep latency, wake after sleep onset, total sleep time, sleep efficiency, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9 and EuroQol-5D-5L. We will conduct the assessment at weeks 0 (baseline), 4 (end of intervention), 8 (post-intervention, primary endpoint) and 12 (follow-up). We will assess each sleep variable from the sleep diary at weeks 0 and 8. The analysis will be performed on an intention-to-treat basis.

Ethics and dissemination
This study has been approved by the Ethics Committee for Clinical and Epidemiological Research of Toyama University (approval no. R2023152).

Trial registration number
UMIN000052911; pre-results.

Stroke, Ahead of Print. BACKGROUND:Early initiation of direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation and acute ischemic stroke is beneficial and safe. Whether prior acute reperfusion therapy modifies the treatment effect of early versus late DOAC initiation is unknown.METHODS:For this post hoc analysis of the multicenter, randomized controlled ELAN trial (Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients With Atrial Fibrillation), all participants with data concerning reperfusion treatment were included. The primary outcome was the composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, major extracranial bleeding, systemic embolism, or vascular death within 30 days. Patients were divided into 4 groups based on prior reperfusion therapy: no treatment, intravenous thrombolysis (IVT), endovascular treatment (EVT), or IVT combined with EVT. We performed logistic regression adjusted for age, hypertension, infarct location/size, pre-modified Rankin Scale, NIHSS, and hemorrhagic transformation, including the interaction term between treatment groups (early versus late DOAC) and reperfusion strategy.RESULTS:We included 1973 of 2013 (98%) patients of the ELAN trial population, with a median age of 77 (71–84) years and of whom 899 (46%) were female. Of them, 1015 (51%) underwent no prior reperfusion treatment, 519 (26%) IVT, 190 (10%) EVT, and 249 (13%) IVT+EVT. We did not identify an interaction for any of the outcome events between prior reperfusion therapy and timing of DOAC initiation. Rates were numerically lower in the early DOAC-initiated group for the following: no reperfusion therapy, 17 (3.3%) versus 24 (4.8%; adjusted odds ratio, 0.69 [95% CI, 0.36–1.28]); EVT, 1 (1.2%) versus 7 (6.4%; adjusted odds ratio, 0.25 [95% CI, 0.03–1.21]); and EVT+IVT, 3 (2.4%) versus 4 (3.3%; adjusted odds ratio, 0.76 [95% CI, 0.17–3.23]). In patients who had received IVT, the rates were 3% (n=8) in the early group versus 2% (n=5) in the late group (adjusted odds ratio, 1.52 [95% CI, 0.52–4.84]).CONCLUSIONS:Prior reperfusion therapy does not modify the effect of early versus late DOAC initiation on clinical outcomes in patients with atrial fibrillation and acute ischemic stroke.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03148457.

Introduction
Youth electronic cigarette (e-cigarette) use is a global health challenge, with multiple jurisdictions wrestling with appropriate responses, in the face of limited evidence available on effective interventions. Identifying and synthesising evidence on the effects of interventions to prevent youth e-cigarette use is required to inform prevention-focussed health policy and practice.

Methods and analysis
We plan to undertake an individual participant data (IPD) prospective meta-analysis (PMA). We will conduct systematic searches to identify eligible planned or ongoing randomised controlled trials (RCTs) using trial registries via WHO ICTRP and ClinicalTrials.gov and databases Medline, Embase, CENTRAL, PsycINFO, Web of Science, CINAHL and Europe PMC. We will also search grant websites for additional studies. We will include any RCT of e-cigarette and cigarette prevention interventions for youth including non-smoking and non-vaping youth aged 10 to 19 years, with no intervention, waitlist, usual care or active control. Primary outcomes will be measures of current or ever e-cigarette use. Secondary outcomes include measures of current and ever cigarette (conventional cigarette) use.
Investigators from relevant trials will be invited to join the Synthesis using Prospective meta-Analysis to Reduce youths’ E-cigarette use (SPARKE) consortium prior to trial outcomes being known using harmonised methods. They are then asked to share their data within 12 months of trial completion.
The primary outcomes will be analysed in a two-stage IPD meta-analysis model under an intention-to-treat framework. First, effect estimates and variances will be calculated for each trial with log-binomial regression models adjusting for key prognostic factors. For cluster RCTs, a nested random effect will be specified within trials to account for correlations within clusters. Second, effect estimates will be combined across trials in a random treatment effect, inverse variance meta-analysis model. Effect estimates will be reported as relative risk ratios with 95% CIs.

Discussion
This study aims to generate and expedite the synthesis of data regarding prevention interventions for adolescent e-cigarette use to inform real-world decision making. Findings will be of interest to key stakeholders, including policy makers and research funders.

Ethics and dissemination
Each trial will be responsible for obtaining their own ethics approval. While secondary analysis of data does not usually require ethics approval, we have received cross-institutional ethics approval from the University of Sydney (2023/714) and the University of Newcastle (H-2023–0389).

Objectives
To update our previous systematic review to synthesise latest data on the prevalence of long-term pain in patients who underwent total hip replacement (THR) or total knee replacement (TKR). We aim to describe the prevalence estimates and trends in this review.

Design
Systematic review and meta-analysis.

Data sources
Update searches were conducted in MEDLINE and Embase databases from 1 January 2011 to 17 February 2024. Citation tracking was used to identify additional studies.

Eligibility criteria
We included prospective cohort studies reporting long-term pain after THR or TKR at 3, 6, 12 and 24 months postoperative.

Data extraction and synthesis
Two reviewers independently identified studies as eligible. One reviewer conducted data extraction, checked by a second reviewer. The risk of bias assessment was performed using Hoy’s checklist. Bayesian, random-effects meta-analysis was used to synthesise the results.

Results
For TKR, 68 studies with 89 time points, including 598 498 patients, were included. Multivariate meta-analysis showed a general decrease in pain proportions over time: 21.9% (95% CrI 15.6% to 29.4%) at 3 months, 14.1% (10.9% to 17.9%) at 6 months, 12.6% (9.9% to 15.9%) at 12 months and 14.6% (9.5% to 22.4%) at 24 months. Considerable heterogeneity, unrelated to examined moderators, was indicated by substantial prediction intervals in the univariate models. Substantial loss to follow-up and risk of bias led to low confidence in the results. For THR, only 11 studies were included, so it was not possible to describe the trend. Univariate meta-analysis estimated 13.8% (8.5% to 20.1%) and 13.7% (4.8% to 31.0%) of patients experiencing long-term pain 6 and 12 months after THR, respectively, though concerns in risk of bias results reduced confidence in these findings.

Conclusions
Our review suggests that approximately 22% of patients report pain 3 months post-TKR, with 12%–15% experiencing long-term pain up to 2 years. At least 14% report pain 6–12 months after THR. Given the prevalence of chronic postsurgical pain, implementing existing and developing new preventive and management strategies is crucial for optimal patient outcomes.

PROSPERO registration number
CRD42023475498.

Introduction
Stroke is a leading cause of death and disability worldwide. Stroke survivors and their caregivers often face profound social isolation and various participation restrictions, resulting in frustration and adverse health outcomes. Dyad-focused interventions, which address both survivor and caregiver needs, are essential during the transition process. However, few interventions equally prioritise the outcomes of both survivors and caregivers. This study aims to evaluate the efficacy of a newly developed dyad-focused strategy training intervention in enhancing participation among stroke survivors and their caregivers.

Methods and analysis
This study employs a single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding. We aim to enrol 138 stroke survivor-caregiver dyads, randomly assigned in a 1:1 ratio to either the experimental intervention group or the control group. Both groups will receive their usual rehabilitation plus 45–60 min sessions of the intervention twice weekly for a total of 12 sessions. Outcome measures, including the Participation Measure-3 Domains, 4 Dimensions, General Self-Efficacy Scale and Activity Measure for Post-Acute Care, will be collected at baseline, post-intervention and at 3-month, 6-month and 12-month follow-ups. Data will be analysed using multiple linear regression and mixed-effects regression models. Qualitative indepth interviews with participants, caregivers and therapists will be conducted post intervention, transcribed and thematically analysed.

Ethics and dissemination
Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N202203083), National Taiwan University Hospital (approval number: 202207096RINA) and Taipei Tzu Chi Hospital (approval number: 11 M-107). Findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals.

Trial registration number
NCT05571150; Preresults.