Winchester

This trial will include 378 participants with active CD, defined as an HBI \> 6 and the presence of endoscopic ulceration. Approximately 50% of the enrolled population will be bio-naïve and 50% exposed to no more than 1 prior biologic. Eligible participants will be randomised 1:1 to either epigenome-guided treatment selection or usual SOC treatment selection. Randomization will be stratified by prior biologic use (yes/no) and corticosteroid use (yes/no) at baseline. Blood samples for the assessment will be collected for all participants during screening. Peripheral blood will be tested via a machine-learning-powered epigenetic biomarker assay. EpiPredict is a software designed for CSV file input, data transfer, storage, and display, and will be serving as a EpiPredict clinical decision support system. It recommends treatment selections for 2 biologics (Vedolizumab (VDZ) and Vedolizumab (UST)) for CD utilizing genetic data. The intervention (EpiPredict software) will indicate the probability of response to both VDZ and UST (though sites will only be provided with the treatment with the highest outcome) for the treatment of CD using a hybrid capture-based methylation assay (approved for research use only) and the EpiPredict software. All participants in the study will be administered their biologic therapy in accordance with the product label and local SOC recommendations. Dose adjustments will be allowed in both groups at the treating investigator's discretion. During the 26-week treatment period, the study assessments will follow the SOC regimen of the assigned biologic treatment. For participants receiving VDZ, study assessments are to occur at Weeks 6, 14, and 26; for participants receiving UST, study assessments are to occur at Weeks 8, 16, and 26. Long-term follow up assessments are to occur every 6 months (Months 12, 18, and 24) after Week 26. Data for long-term follow up assessments will be collected from the participant's medical records captured at routine SOC visits and online questionnaires.

TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) and the presence of AD pathology.

Giant cell arteritis (GCA), also known as temporal arteritis, is the most common form of primary systemic vasculitis, with up to 75,000 cases a year identified in the EU and US. It occurs almost exclusively in people over the age of 50 years and is considered to be a medical emergency. If not treated with high-dose glucocorticoids immediately, the thickening of the inflamed blood vessel wall can cause irreversible visual loss or stroke. GCA can lead to significant morbidity across a variety of systems, due to both the disease, and complications of treatment. Diagnosis may be confirmed with a temporal artery biopsy, imaging (e.g. USS/CT/MRA/PET-CR) or based on clinical signs (e.g. erythrocyte sedimentation rate) and symptoms (e.g. a new headache, jaw claudication, visual disturbances, temporal artery abnormality such as tenderness or decreased pulsation) . Polymyalgia rheumatica (PMR) is characterised by inflammatory limb-girdle pain with early morning stiffness, and a systemic inflammatory response demonstrated by elevated inflammatory markers. The UK GCA Consortium is a multi-centre observational study, the main arms of which recruit prospective (participants with suspected GCA) and retrospective cohorts (participants with confirmed GCA diagnosis). Analysis of data collected on these cohorts will help achieve the primary aim of finding genetic determinants of GCA and PMR susceptibility, in order to yield novel insights into disease pathogenesis. Secondary aims, and their associated analyses, are as follows: * Phenotype: characterising GCA and PMR subtypes, based on clinical features; imaging; cells; subcellular fractions and molecules in the circulation and/or arterial tissue; genetic/epigenetic/transcriptomic/proteomic or metabolomics factors, including next generation sequencing (whole exome sequencing) of selected cases. * Life impact: determining what aspects of the disease and treatments affect patients' quality of life, as assessed by patient-reported outcomes. * Long-term outcomes: characterising prognosis of GCA and PMR - both effects of the disease and its treatment - by longitudinal follow-up through electronic linkage to health records. * Exploratory analyses: exploring the potential role of environmental factors and co-morbidities on phenotype and outcomes. * Diagnosis, prognosis: improving diagnosis of GCA and PMR, and identifying factors that predict diagnosis, such as diagnostic clinical features, and prognostic and diagnostic biomarkers. * Disease activity: monitoring participants who commence a synthetic or biological disease-modifying anti-rheumatic drug (s/bDMARD). Finding a biomarker for GCA and PMR disease activity, which might be clinically useful in helping to optimise steroid and s/bDMARD treatments for individual patients.

Randomised, phase II/III 3 stage trial to evaluate the safety and efficacy of the addition of olaparib to platinum-based neoadjuvant chemotherapy in breast cancer patients with TNBC and/or gBRCA. Disease under investigation: Breast Cancer Purpose of clinical trial: To establish if the addition of olaparib to neoadjuvant platinum-based chemotherapy for Triple Negative Breast Cancer (TNBC) and/or germline BRCA (gBRCA) breast cancer is safe and improves efficacy. Trial Design: Open label, randomised, 3-stage Phase II/III Sample Size: Minimum of 780 patients (including at least 220 gBRCA patients equally allocated to the control and the selected research arm). Non Investigational Medicinal Products: Prophylactic granulocyte-colony stimulating factor (G-CSF) to be given as per local practice and 3 cycles of anthracyclines as per local practice. Treatment period: A minimum of 21 weeks of chemotherapy followed by surgery. Procedures: Screening \& enrolment Eligible patients with early breast cancer will be registered and consented for screening: BRCA mutation test Tumour Infiltrating Lymphocytes(TILs) score Cytokeratin 5/6 (CK5/6), Epidermal Growth Factor Receptor (EGFR) +/-, Androgen Receptor (AR) status by Immunohistochemistry (IHC). Standard assessment prior to chemotherapy Standard staging to exclude metastatic disease. When eligibility is confirmed, patients will be randomised via a web-based central system which will allocate each patient a unique randomisation number associated with one of the treatment arms. PARTNERing Pathway - For those patients who still have residual disease after receiving neoadjuvant chemotherapy +/- olaparib there is the opportunity to be screened to a sub-study to receive a further two cycles of chemotherapy consisting of Duralumab and AZD6738. End of Trial: For patients, the end of trial is after the last follow-up visit or contact with the research team planned 10 years after surgery. Procedures for safety monitoring during trial: Pharmacovigilance will be performed by the PARTNER Trial Office. Also, the Trial Management Group and the Independent Data and Safety Monitoring Committee will regularly review the patient safety data. Criteria for discontinuation of trial treatment on safety grounds: Severe toxicity or inter-current illness, requiring cessation in the judgement of patient's clinician. Patient within 4 weeks has not recovered from toxicity to an extent that allows further treatment. Patient unable to comply with trial procedures. Disease progression while on trial treatment. Patient becomes pregnant.

This is a Post Market Clinical Follow Up Study in Orthopaedics. It will verify the long-term safety and performance of the device in the intended patient population, when indicated for the reconstruction of a ligament in the kneecap - the Medial Patellofemoral Ligament (MPFL). The Medical Devices in this study, 10mm Poly-Tape and 5mm Infinity-Lock Tape, are Class III CE-Marked devices manufactured by Xiros Ltd. Both devices fall under the Poly-Tape family. Poly-Tapes are single-use devices, they are indicated for patients requiring soft tissue approximation and reconstruction of ligaments and tendons. The device can be fixed to the bone using several different methods, including screws. This study is a prospective, multicentre, consecutively recruited non-randomised study. The total length of the study is expected to be 7 years. This includes a recruitment period of approximately 24 months and a 5-year follow-up. A total of 55 subjects will be enrolled into the study with follow up at 6 months, 1 year, 2 years and 5 years in clinic and by questionnaires. All subjects treated with either the 10mm Poly-Tape or 5mm Infinity-Lock Tape for MPFL reconstruction, will be consecutively recruited into the study.

Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an intensive care unit (ICU) is associated with substantial mortality. Patients with pneumonia who are being treated in an ICU will receive therapy that consists of many different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don't always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best. This clinical study has been designed in a way that allows the information from patients already in the study to help new patients joining the study. Most studies aren't able to do that. REMAP-CAP has been designed to: * Evaluate multiple treatment strategies, at the same time, in the same patient. * Reach platform conclusions when sufficient data is accrued, rather than when a pre-specified sample size is reached * Utilise data that is already accrued to increase the likelihood that patients within the trial are randomised to treatments that are more likely to be beneficial * New questions can be substituted into the trial as initial questions are answered, meaning that the trial can be perpetual or open-ended * Interactions between interventions in different domains can be evaluated It is reasonable to presume that any pandemic respiratory infection of major significance to public health will manifest as life-threatening respiratory infection including Severe Acute Respiratory illness and severe Community Acquired Pneumonia (CAP) with concomitant admission to hospital, and for some patients, admission to an Intensive Care Unit (ICU). Previous pandemics and more localized outbreaks of respiratory emerging infections have resulted in severe CAP and ICU admission. Previous pandemics and outbreaks of emerging infectious diseases have outlined the urgent need for evidence, preferably from Randomized Controlled Trials (RCTs), to guide best treatment. However, there are substantial challenges associated with being able to organize such trials when the time of onset of a pandemic and its exact nature are unpredictable. As an adaptive platform trial that enrolls patients during the interpandemic period, REMAP-CAP is ideally positioned to adapt, in the event of a respiratory pandemic, to evaluate existing treatments as well as novel approaches.

This is an observational multicentre retrospective and prospective cohort study, and a qualitative study. The project will have three working packages: * Work package 1 - maintenance of a colorectal surgery database * Work package 2 - prospective collaborative national UK study * Work package 3 - qualitative analysis with semi-structured interviews WORK PACKAGE 1 - COLORECTAL SURGERY DATABASE: Data collected includes: * Basic demographic information * Co-morbidities at time of surgery * Other cancer treatments * Final cancer staging and diagnosis * Type of procedure * Methods of reconstruction * Use of healthcare resource: (theatre time, surgical teams, use of consumables, index operation intensive care stay, total length of stay, planned or emergency readmissions, use of imaging for complications, re-interventions, and outpatient clinic use). * Morbidity - empty pelvis syndrome complications with collation of all complications that occurred summarised into: (the highest Clavien-Dindo (CD) score, and the comprehensive complication index by accumulating CD graded complications that a patient has as a result of their surgery. * Survival: overall and disease-free survival * Patient reported outcome measures Any other routinely collected clinical data will be included. Of particular mention we will include and analyse Cardiopulmonary exercise testing data, data derived from the perioperative medicine screening and assessment, data derived from prehabilitation, radiomic data e.g. muscle/fat structure and function derived from CT, MRI or PET-CT. WORK PACKAGE 2 - PROSPECTIVE COLLABORATIVE STUDY: Abdominoperineal excision and pelvic exenteration can be used in a wide range of cancer types, and in the case of pelvic exenteration can be used to manage both recurrent and primary cancers. The principal PROM used will be the EORTC QLQ-C30 with its modular questionnaires giving additional insight into disease-specific quality of life. All amendments have been made in line with NIHR RfPB funding received in November 2024. Patients will be recruited once a decision to undertake abdominoperineal excision or pelvic exenteration surgery has taken place. Participants will be sent a participant information sheet which will include the dates of when participants can expect follow up telephone calls, with information on how to contact the study team to change these should participants wish to. Once consented participants will undergo the following PROMs as part of their baseline questionnaire: * EORTC QLQ-C30 with specific cancer-type modules * EQ-5D-5L * LRRC QoL * Decision Regret * Comprehensive Score for Financial Toxicity (COST), financial status questionnaire (non-validated) and Patient employment status questionnaires. The investigators anticipate that participants will be able to self-assess the above PROMs on a paper printed form, however a member of the research team will be available to support the participant if required. Clinical information will also be collected pre-operatively, including: demographic information, co-morbidities, cancer staging, and previous cancer treatments. Patients will be given copies of the follow up questionnaires at this time so participants have them as a reference when completing follow up questionnaires. Patients can opt for either email or telephone follow up for quality of life, if opting for email REDCap study will automatically send out emails based on the date of surgery. The patient will then undergo their surgery with method of reconstruction at the discretion of the operating surgeon(s). Following the index admission researchers will enter details on the hospital stay: * Type of procedure * Methods of reconstruction * Theatre time * Theatre teams * Use of consumables * Length of intensive care and hospital stay * Use of imaging for complications * Re-interventions for complications * Discharge destination following index admission * Final cancer staging and other pathological outcomes. * Perineal and empty pelvis morbidity, and overall Clavien-Dindo and Comprehensive Complication Index * NHS healthcare utilisation costs * If applicable survival and cause of death At 3 months post-operatively questionnaires will be repeated over the telephone including: * EORTC QLQ-C30 with cancer-specific module * EQ-5D-5L * LRRC QoL * Decision Regret * Comprehensive Score for Financial Toxicity (COST), Patient reported heath resource utilisation and NHS healthcare utilisation costs. At this same time point researchers will review routinely collected clinical data and use of in-hospital health resources to include: * In-hospital health resource use: planned or emergency re-admissions, use of imaging to investigate complications, re-interventions (surgical and radiological), planned or unplanned outpatient visits. * Longitudinal CCI scores updated, and if applicable an increase in CD if a more severe complication develops. * If applicable cancer recurrence, survival and cause of death will be recorded. Patients will be emailed or telephoned on the date specified on their participant information sheet, however if this time is not convenient then a better time will be arranged with the patient. If participants do not respond to the email or first telephone call then the investigators will make a further three separate attempts to contact the patient. If there is still no response participants will be deemed lost to the study. This follow up process will be repeated again at 6 months and 12 months. At the 12 month time point the investigators will ask patients additional questions on their use of health care resources and their current financial status, to include: * Use of community health resource use due to complications including: GP appointments and nursing home care days required for recovery from surgery. * Use of healthcare resources at hospitals other than the treating hospital - clinic appointments and admissions At the end of this time the patient will have completed the study. WORK PACKAGE 3 - QUALITATIVE STUDY: The qualitative study will recruit patients from work packages 1 and 2. The investigators will invite 30 purposefully sampled patients that are 3 months following their surgery. Suitable patients will be contacted with a posted participant information sheet and a telephone follow up call to allow participants to ask questions about the study. Following informed consent semi-structured interviews will take place with semi-structured open questions to guide the discussions. Interviews will be recorded on an encrypted audiorecorder and then transcribed. The investigators will initially undertake three pilot interviews to review that the semi-structured interview schedule is adequate to fully explore our objectives and to obtain good quality interview transcripts for analysis. These pilot interviews once completed will be reviewed by the research team. The semi-structured interview schedule questions may be changed if the interviews are of poor quality, pilot interviews demonstrate new insights from participants that suggest fruitful lines of enquiry, or inconsistencies that require further exploration. If subsequent interviews are very different than the pilot interviews following these changes, then these early interviews will not be included in the qualitative analysis and additional patients will be recruited. Patients recruited at 3-months following surgery will be offered a repeat interview at 12-months following their surgery DATA ANALYSIS PLAN: Statistical analysis: The investigators will be collecting data on the timepoints as described above. Continuous data will be will be summarised using descriptive statistics (mean, median, standard deviation, lower and upper quartiles). Categorical data will be summarised using counts and percentages. As studies are non-randomised, the investigators will utilise regression models and principal component analysis to adjust for confounding in this observational study. In order to obtain our outcomes a brief summary of analyses is below. Work package 1 (Colorectal Database): Primary analysis: \- Frequency of morbidity relating to the empty pelvis syndrome and perineal wound will be compared for different types of perineal reconstruction will be analysed using multiple linear regression. Secondary analysis: * Overall morbidity will be obtained using highest CD scores for different methods of perineal reconstruction analysed using multiple linear regression. * Disease free and overall survival will be analysed using Kaplan-Meier curves and log rank tests with a multivariate Cox regression hazard model to identify factors independently associated with survival, including method of reconstruction. Exploratory analysis: * Other factors including age, gender, BMI, final staging, co-morbidities, type of operation, neoadjuvant chemoradiotherapy and use of intra-operative electron radiotherapy will be included in the analysis * Other outcomes including primary operation time, lengths of stay, and readmissions will be explored Work package 2 (prospective study): Primary and secondary analysis: * Patient reported outcome measures will be analysed using regression models, including linear mixed-effects models for repeat measures and adjusted analyses. * The same clinical data fields will be collected as per work package 1, the analysis above repeated with exploratory analysis to find factors that are independently significantly associated with changes in the PROMs. Health economic analysis: Work package 1 (retrospective study): The investigators will collect data on use of hospital healthcare resources in each patient group. The investigators will collect resource use for each parameter required for each patient. The investigators will then undertake costing using a micro-costing approach and health resource group costing for each parameter. Applying costs to each parameter will use a combination of manufacturer prices for consumables, National Cost Collection for the NHS, National Schedule of NHS Costs, NHS National Tariff and the Unit Costs of Health and Social Care from the Personal Social Services Research Unit. The investigators will then report overall costs associated with different methods of perineal reconstruction and the cost of complications that were encountered. Work package 2 (prospective study): The investigators will collect hospital healthcare resource use data prospectively and apply micro-costing to these parameters in the same way as per work package 1 for each patient and their method of reconstruction. The investigators will also ask patients to provide us with use of community healthcare resources as a result of their surgery, data for which the investigators will not be able to obtain from their clinical notes. Participants will receive EQ-5D-5L and EORTC QLQ-C30 questionnaires at baseline, 3 months, 6 months and 12 months. From these responses the investigators will map onto EQ-5D-3L in order to reduce the overall number of questionnaires patients are undertaking in our study. This will allow us to plot EQ-5D-3L responses for different methods of reconstruction and plot the area under the curve. Within the trial time a health economic model would be built which would follow the NICE reference case and ISPOR Task Force guidelines on health economic analysis. This will enable us to present Quality Adjusted Life Years and incremental cost-effective ratios for the different methods of perineal reconstruction. Qualitative analysis: Audio transcription will be transcribed verbatim, checked against the recording and anonymised. Data will be uploaded to NVivo for data management. Preliminary summaries will be written after each interview to identify emerging themes to follow-up discussions. The follow-up interview will ask patients to reflect on the content of their previous interview and discuss any changes. Longitudinal interview analyses will use constant comparative methods from grounded theory and data coded using NVivo's framework matrix facility to examine themes longitudinally, enabling comparisons within each case and across cases, focusing on changes over time. The stages of data analysis, drawing on longitudinal comparisons, will include: 1. Initial reading: Review interview data. 2. Preliminary coding: Two researchers code the data. 3. Team meeting: Discuss and refine codes with wider research/PPI team. 4. Individual Case Coding: Code all interview data for each participant. 5. Categorising Codes: Group codes into categories for each case. 6. Longitudinal comparisons: Within case and category comparisons focussing on changes over time. 7. Focused coding: Examine categories in relation to emerging concepts and phases. 8. Discussion on Themes: PPI co-led focus group discussions of final themes. 9. Development and Dissemination: Report write up are dissemination. Based on an iterative process, emerging themes will be used to develop explanatory accounts. Analysis will draw on sociological perspectives of illness adaptation, recovery and self-management in addition to psychological theories of individual behaviour change. All qualitative and quantitative data will inform 3 patient focus groups, where PPI and charity collaborators along with 5 newly trained PPI members will discuss data analyses from a patient perspective, contributing to initial discussions around developing a patient decision aid.

Twenty stroke patients will be recruited for this study. Participants will take part in four seperate assessments (2 hours each) with a minimum of 24 hour recovery between each session. Before each assessment participants will undertake an overnight fast (only water is allowed to be consumed prior to the assessment). If required, participants will take their medication the morning of each assessment and this will be noted.During the first session participants will be randomised into either a supine or seated condition. Participants will rest in this posture for 15 minutes. Triplicate measures of peripheral blood pressure and pulse wave analysis will be measured using the SphygmoCor XCEL and Vicorder device. A 3-lead ECG will be placed on the participant and ultrasound measures will be taken at the carotid, brachial, femoral and posterior tibial artery. This will examine the caroid-femoral pulse wave velocity (cfPWV), brachial-femoral pulse wave velocity (bfPWV), brachial-ankle pulse wave velocity (baPWV) and femoral-ankle pulse wave velocity (faPWV). Following this, the Vicorder device will be used to measure these segments. All measures will be on both symptomatic and asymptomatic sides. This procedure will be repeated in a seperate session whereby individuals will be in the other posture. Session 3 and 4 will include participants resting for 15 minutes in a supine position. Triplicate measures of peripheral blood pressure and pulse wave analysis will be taken with the Vicorder. Followed by triplicate measures of cfPWV, bfPWV, baPWV and faPWV. This will be repeated in a seated position within the same session.

Waldenström's macroglobulinaemia (WM) is a rare type of slow growing lymphoma. It develops when white blood cells grow abnormally. Typically a disease of the elderly, the median age of presentation is \>70 years and the current treatment for WM is unsatisfactory, with incomplete responses and inevitable recurrence. Therefore there is a need to find alternative treatments that are more effective, leading to lasting responses and improved quality of life. The RAINBOW study is a phase 2-3 trial assessing 'chemotherapy free' treatment as primary therapy for WM which can potentially improve response outcome, durability and importantly, reduce toxicity for WM patients. This approach will be done using the drug Ibrutinib, which in combination with rituximab (RI) will be the experimental arm. As there is no agreed standard on first-line therapy for WM, the control arm is the current treatment based on the most recently published clinical trial results. The control arm consists of rituximab, cyclophosphamide and dexamethasone (DCR), and is widely recommended by international consensus as appropriate treatment for first-line therapy for WM. In this study, 148 adults (aged ≥ 18 years) with treatment naïve WM will be randomised on a 1:1 ratio to either the treatment or control arm. Randomised treatment lasts for a maximum of 6 cycles and response will be assessed following 3 cycles of treatment and completion of randomised treatment at approximately 24 weeks after commencing treatment. RI patients may then have up to 5 years of Ibrutinib monotherapy. Patients will be seen regularly during treatment and then every 3 months for 5 years after treatment discontinuation. Patients will enter annual follow up for survival until the end of trial (including progressed patients). The study will be conducted at NHS hospitals and is expected to last 9 years and 6 months.

The design of the study This study will be a retrospective-matched non-randomised trial. The physical activity and cardiovascular health of stroke patients using the Lokomat at an inpatient stroke unit (Royal Bournemouth Hospital) will be monitored over time. The same measurements will be conducted with another set of patients at another stroke unit (Royal Hampshire County Hospital) who do not receive any form of RAGT. These patients will be matched retrospectively with those who used the Lokomat at the first study site, and then the results of the two sets of patients will be compared. Both sets of patients will satisfy the inclusion and exclusion criteria. Matching of participants will be based upon baseline Functional Ambulation Category (FAC) score; blood pressure, and age. All members of the research team were involved in the design of this study. Recruitment At the first research site (Royal Bournemouth hospital), when a new patient enters the stroke unit, the care team will assess whether the patients is suitable to receive Lokomat training (as per standard care). If the patient is going to receive Lokomat training, and they satisfy the inclusion criteria of the study (assessed by a member of the clinical care team), a member of the care team will then explain the study to the participant, and provide an information sheet to the patient. They will then have an opportunity to ask any questions they have to either the care team or the research team. If they then decide that they want to participate, then informed written consent will be obtained by a member of the care team. Study participation will not influence which patients are offered or receive RAGT. The patients will not be offered any extra or any fewer sessions if they do or do not decide to participate in the study, and it will be made clear that participation will not influence the care they receive in any way. At the second research site (Royal Hampshire County Hospital) a member of the care team will identify any patient who fits the inclusion criteria. They will then be approached and asked whether they want to hear about the study by a member of the research team. If they do, a member of the research team will explain the study and provide an information sheet. They will then have an opportunity to ask any questions they may have. If they decide that they want to participate in the study, then informed written consent will be obtained by the research team member. Informed consent Potential participants will firstly have a discussion with a member of the research team regarding the study. If they are interested in participating, they will be provided with an information sheet, which will outline the details of the study. The information sheet will include information regarding the purpose of the research, the risks, or burdens to participants (e.g., extra assessments taken, wearing an accelerometer), and details to ensure they know they can withdraw from the study at any time without any consequences. It will also ensure the patient knows participation is entirely voluntary and will not affect their care. The care team will determine whether a patient has capacity to make the decision whether to participate or not. If determined to be suitable for the study, the patient will complete a written informed consent sheet. There will be an aphasia friendly version of the information sheet and consent form. Confidentiality Participants will be assured of the confidentiality of the research process. All data will be anonymised using alpha-numeric code which will be stored on a password protected network, accessible by only the named researchers involved in the study. Any hard copies of data will be kept in a locked filing cabinet at the University of Winchester (King Alfred campus, Centre for Sport). The only people with access to this filing cabinet will be the named researchers. Due to collaboration between members of the University of Winchester and staff at both stroke units, data will be uploaded to a secure password protected folder on Microsoft OneDrive. Again, only the named researchers will have access to this. When the results of the study are published, all data will be presented as group means and standard deviations. The minimum amount of person-identifiable data will be collected as possible, and current UK General Data Protection Regulation (GDPR; Regulation (EU) 2016/679 of the European Parliament and of the Council of 27th April 2016) rules will be followed. All members of the research team will have completed GCP (Good Clinical Practice) training prior to the study starting. Risks/burdens Participants will be asked to complete several functional assessments at the following timepoints - baseline, every 2 weeks whilst in inpatient care up to 6 weeks, and a follow up 3-months post stroke onset. These tests will be the Timed Up and Go test (TUG), Functional Ambulation Category (FAC) and 2-minute walk test (2MWT). The TUG and FAC assessments are routinely conducted at both hospitals as part of the care. However, if these have not been conducted at each timepoint, then these two tests may have to be conducted in addition to their usual care. The 2MWT is not routinely conducted, and therefore will take up just over 2 minutes of the patient's time (due to time spent explaining and preparing for the test). To minimise risks, the care team at the stroke unit will be present and confirm that the patient can safely complete these tests while they are in inpatient care (otherwise the tests will not be conducted). Therefore, the burden of these additional assessments is that this will take up some of the patient's time. However, these are all quick tests, and will only take around 10 minutes to complete all 3 assessments. Additionally, participants will be asked to wear an ActivPAL accelerometer for 3 days at a time, at the same timepoints as for the functional assessments (baseline, every 2 weeks whilst in inpatient care for first 6 weeks, and a follow up 3-months post stroke onset). This is a small and unobtrusive device but could be seen as a burden by the participant, as they will need to wear it on their thigh for an extended period. Patients will be told about this requirement of participation before they decide whether to participate in the study or not. To minimise irritation/discomfort to the participant, the research team member who fits the device will ask the patient whether it is comfortable and readjust if not. As well as the participant, ward staff will be shown how to adjust the device, so it is more comfortable. In addition, they will be shown how to take off the device should the participant want it removed, or if there were any concerns. Finally, participants will also have Pulse Wave Analysis (PWA) and Pulse Wave Velocity (PWV) assessments conducted at each timepoint. This is a non-invasive and safe test, but the participant will need to be lying down for 20 minutes. The time burden of these assessments will also be explained and included on the information sheet so that the potential participants understand the requirements of participation. Numerous cuffs will be placed on the patient's body and attached to the Vicorder device for this time, which allows for central and peripheral blood pressure to be measured in a non-invasive way, as well as measures of arterial stiffness. A member of the research team who has experience using this device as well as the appropriate NHS honorary contract will be conducting these tests. If the patient has been discharged, the follow-up tests will be conducted at the patients' home, 3-months post stroke onset. The patient will confirm that they are comfortable and able to complete any tests before they are completed at the home. A risk assessment will be undertaken before each assessment, and any trip hazards will be removed (or change where the test takes place if object is immoveable). A member of the research team will walk behind the patient during the assessments in case support is needed. If the participant has not been discharged by this point, then the tests will be conducted at the stroke unit with a member of the care team present. Additionally, it will be made clear to participants that if they do not feel up to completing an additional test at any timepoint they will not be negatively affected in any way. Study protocol After a patient has provided informed written consent, they will be enrolled onto the study. The consent form will include consent to obtain data from medical records. The patient's height; weight; age; sex; stroke severity and type; National Institute of Health Stroke Scale; date of stroke onset and blood pressure will be recorded. Once demographic data has been recorded, baseline assessments (prior to RAGT use if recruited from Royal Bournemouth Hospital) will be conducted. These tests will include: pulse wave velocity and pulse wave analysis (via the Vicorder device); collection of accelerometer data (through wearing the ActivPAL for a period of 3 days); and completion of functional assessments (FAC, TUG, 2MWT). To collect pulse wave velocity and pulse wave analysis data, participants will be required to lie down for 30 minutes. Several cuffs will be places on the ankle, thigh, arm and neck of the participant, which are attached to the Vicorder device. These inflate and so the participant will feel a small amount of pressure. This will be conducted by a member of the research team who has experience conduction this test and hold an NHS honorary contract. For the accelerometer data collection, the ActivPAL will be attached to the participants thigh for 3 days. It is a small accelerometer device, and can be removed before the 3 day period has finished should the participant wish to end this assessment early. This will be placed and taken off by a member of the research team, who will have an NHS honorary contract. The care team will be shown how to remove the device in case the patient wants to stop the data collection and a member of the research team is not present. The first functional assessment is the FAC. This is an observational assessment of the patients movement level and will be carried out by a member of the care team, as per routine care. The TUG test will be conducted by a member of the research team, once a member of the care team has confirmed that it is safe for the participant to complete the test. This test requires a participant to stand up from a chair, walk 3 metres, turn around, walk back to the chair and sit down. The 2MWT is a test of how far the participant can walk in 2 minutes. Again, a member of the research team will conduct the test once a member of the care team has confirmed that it is safe at the time of assessment for the participant to complete this test. Patients will continue their normal care; with details of the therapy sessions (conventional physiotherapy and RAGT) being documented by the medical team. The date, time, length of session, and, if an RAGT session, the number of steps completed will be recorded. This will be recorded on a physical sheet kept at the hospital, and later transferred to a password-protected Microsoft OneDrive folder once data has been anonymised through coding. Every 2 weeks the participant is in inpatient care up to a maximum of 6 weeks, they will have the set of the assessments repeated. The final data collection session will happen at 3-months post stroke onset, which marks the end of the early subacute stroke stage. This will be conducted at the home of the participant for most people, following discharge from the stroke unit. However, if they are still at the stroke unit, the final assessment will be conducted there. The data from the two sets of participants (those exposed to RAGT and those who were not) will be compared and analysed. Once the patient's involvement in the study has ended, they will receive a personalised report (assuming they have provided consent to be contacted at a later date by a member of the research team). This will include details on their personal accelerometer/physical activity levels, functional assessment results and cardiovascular health results. Once the study has concluded, and data has been analysed, a report of the overall study findings will be sent to each participant (assuming they have provided consent to be contacted at a later date by a member of the research team).