Trials最新文献

{"title":"Transcutaneous tibial nerve stimulation versus sham stimulation for the treatment of catheter-related bladder discomfort in patients undergoing transurethral resection of the prostate: a prospective, randomized, placebo-controlled, double-blind trial.","authors":"Yanwen Song, Xiangyu Sun, Ling Mei, Yongqiang Wang, Jiangang Song","doi":"10.1186/s13063-026-09743-y","DOIUrl":"https://doi.org/10.1186/s13063-026-09743-y","url":null,"abstract":"<p><strong>Background: </strong>Catheter-related bladder discomfort (CRBD), characterized by urinary urgency, frequency, and suprapubic pain, is a clinically significant complication following transurethral resection of the prostate (TURP). Current CRBD pharmacotherapy faces inherent limitations due to adverse effect profiles. Transcutaneous tibial nerve stimulation (TTNS), a noninvasive neuromodulation therapy with demonstrated efficacy in bladder dysfunction management, shows particular promise as a safe and effective alternative for CRBD treatment.</p><p><strong>Methods: </strong>This prospective, randomized, double-blind, placebo-controlled clinical trial enrolled patients undergoing TURP under general anesthesia. Participants were randomly allocated in a 1:1 ratio to either active TTNS intervention or sham stimulation. The primary outcome focused on CRBD-related discomfort severity assessed via the Numeric Rating Scale (NRS) immediately post-intervention. Secondary outcomes comprised CRBD severity and pain scores at 1-, 2-, and 6-h post-intervention intervals, analgesic consumption, patient satisfaction ratings, and occurrence of postoperative delirium.</p><p><strong>Discussion: </strong>This protocol evaluates the therapeutic potential of TTNS for CRBD following TURP, exploring its viability as a non-invasive alternative to current CRBD management.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2400088488. Registered on 20th August 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Labelling of subpleural pulmonary nodules with blue dye and contrast agents under CT-guided control and subsequent video-assisted thoracoscopic resection: the BLUEPAT prospective randomised study.","authors":"Zdeněk Chovanec, Vladimír Červeňák, Ivan Čundrle, Michal Šitina, Jiří Vaníček, Alena Berková, Tomáš Hanslík, Igor Penka, Lenka Součková","doi":"10.1186/s13063-026-09748-7","DOIUrl":"https://doi.org/10.1186/s13063-026-09748-7","url":null,"abstract":"<p><strong>Background: </strong>Colour marking of indicated nodules is an innovative, accurate, and gentle method that allows subsequent wedge resection of the marked tissue using a mini-invasive, video-assisted thoracoscopic (VATS) method with all its benefits. One of the expected benefits of this clinical trial is introducing and optimising the evaluated way into routine management in diagnosing and treating focal lung diseases. The BLUEPAT clinical trial aims to assess the technique of colour marking of subpleural deposited small lung nodules with the subsequent performance of VATS wedge resection in surgical practice.</p><p><strong>Methods: </strong>The BLUEPAT clinical trial is a prospective, monocentric, open-label, randomised study that will include 72 participants with subpleural deposited nodules with the need for additional histological diagnostics to optimise subsequent treatment. These patients will be randomised into two arms in a 1:1 ratio. The interventional arm will undergo VATS wedge resection of lung nodules marked with Patent Blue V and contrast agent iohexol under CT-guided control. The control arm will undergo VATS resection without prior colour coding of the lung nodules. The feasibility and safety of both methods will be assessed based on the evaluation of the parameters of the primary and secondary objectives of the study. The safety of the methods will be monitored by recording all related adverse events. All enrolled patients will undergo a 30-day follow-up period within the framework of clinical trial.</p><p><strong>Results: </strong>This article reports the clinical trial protocol; outcome data will be published upon study completion.</p><p><strong>Discussion: </strong>The BLUEPAT clinical trial offers a novel assessment of this innovative approach for the diagnosis and treatment of focal lung diseases. The use of patent blue dye has been well established in diagnostic procedures for breast cancer and this study extends its potential application to pulmonary indications.</p><p><strong>Trial registration: </strong>EudraCT Number 2021-001122-22. Registered on March 18, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of anesthesia efficacy between subclavius muscle plane block and interscalene brachial plexus block for open reduction and internal fixation of clavicle fractures: study protocol for a randomized non-inferiority clinical trial.","authors":"Chen-Guang Li, Wei Yuan, Jie Wei, Chun-Yan Mou, Jia Guo, Fan Zhong, Kun Fan, Wen-Yi Gong","doi":"10.1186/s13063-026-09751-y","DOIUrl":"https://doi.org/10.1186/s13063-026-09751-y","url":null,"abstract":"<p><strong>Background: </strong>Interscalene brachial plexus block (ISBPB) combined with supraclavicular nerve block or superficial cervical plexus block has been reported to be a reliable, efficacious anesthesia technique for clavicle fracture surgery. However, several serious adverse events impeded the development of this technique. Herein, we propose a novel nerve block technique-the subclavius muscle plane block (SMPB) combined with supraclavicular nerve block-that selectively targets the sensory nerves innervating the surgical region of the clavicle. We hypothesize that SMPB may achieve non-inferior anesthesia efficacy for clavicle surgery compared to ISBPB when combined with supraclavicular nerve block, with fewer complications.</p><p><strong>Methods: </strong>This study is a prospective, single-center, randomized, controlled, non-inferiority trial. A total of 76 patients scheduled for open reduction and internal fixation of clavicle fractures will be divided into two groups at random to receive either SMPB or ISBPB, combined with supraclavicular nerve block. The primary outcome will be to compare the proportion of patients not requiring sufentanil supplementation intraoperatively between the two groups. The secondary outcomes will include the pulmonary function before and 30 min after the block, onset time of anesthesia, block-related complications, conversion rate to general anesthesia, intraoperative sufentanil supplementation, surgery duration, intraoperative hemodynamic adverse events, first onset time of pain, first time to patient-controlled bolus, postoperative sufentanil consumption, Numerical Rating Scale scores for rest and dynamic pain at 3, 6, 12, and 24 h postoperatively, motor block grade at 3, 6, 12, and 24 h postoperatively, postoperative nausea and vomiting, metoclopramide dose, nerve injury, patient satisfaction score, and surgeon satisfaction score.</p><p><strong>Discussion: </strong>This study explores the SMPB as a novel anesthetic technique for clavicle surgery. Compared to ISBPB, SMPB may offer effective anesthesia while reducing complications regarding limb immobility and phrenic nerve paralysis, thus potentially enhancing patient safety, comfort, and postoperative recovery.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Register, ChiCTR2500096952. Registered on February 10, 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness and mechanisms of digital cognitive and physical function prehabilitation for improving prognosis in kidney transplant recipients: protocol for a randomised controlled trial.","authors":"Xiaojie Ma, Jindong Ding Petersen, Bonuan Yao, Rui Chen, Tianyu Zhi, Yang Guo, Dingqun Bai, Hongtao Jiang","doi":"10.1186/s13063-026-09746-9","DOIUrl":"https://doi.org/10.1186/s13063-026-09746-9","url":null,"abstract":"<p><strong>Introduction: </strong>Frailty and cognitive impairment are highly prevalent among patients on the kidney transplant waitlist (KTWs), contributing to poor post-transplant outcomes. While digital health interventions have shown promise in chronic disease management, their application as a comprehensive prehabilitation tool for KTW patients remains largely unexplored. This study aims to evaluate the effectiveness of a digital cognitive and physical prehabilitation program in improving the prognosis for KTW patients. Furthermore, it seeks to investigate the underlying biological mechanisms, focusing on the inflammation-muscle-brain axis.</p><p><strong>Methods: </strong>This single-center, assessor-blinded, randomized controlled trial will enroll 100 eligible KTW patients. Participants will be allocated (1:1) to either an intervention group or an active control group. The control group will receive standard care plus a digital platform for daily health management. The intervention group will receive, in addition, a 12-week, home-based program of digitally supervised exercise (aerobic and resistance) and cognitive training.</p><p><strong>Results: </strong>The primary outcomes will include changes in physical function (evaluated through the 6-min walk test, sit-to-stand test, timed up-and-go test, and handgrip strength) and cognitive function (assessed using the Montreal Cognitive Assessment and Digit Symbol Substitution Test). Key clinical transplant outcomes, such as delayed graft function, graft survival, patient survival, and rejection episodes, will also be assessed. Secondary outcomes will encompass longitudinal changes in biomarkers related to the inflammation-muscle-brain axis (including inflammatory cytokines, myokines, and neurological markers), as well as patient-reported quality of life (SF-36) and vascular function (brachial-ankle pulse wave velocity).</p><p><strong>Conclusion: </strong>This study will provide critical evidence on the implementation of a multimodal digital prehabilitation strategy in KTW patients. The results are expected to inform future clinical guidelines and offer a scalable model to optimize pre-transplant fitness.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry (ChiCTR) identifier number: ChiCTR2500104025. Registered on 10 June 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147780909","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of tDCS on brain function in patients with post-stroke cognitive impairment: a randomised controlled study protocol based on TMS and fNIRS.","authors":"Yuan Zhu, Hongxia Duan, Qun Zhang, Peijun Li, Linhong Jiang, Yidie Bao, Wenxiang Li, Min Zhuang, Xiaodan Liu","doi":"10.1186/s13063-026-09689-1","DOIUrl":"https://doi.org/10.1186/s13063-026-09689-1","url":null,"abstract":"<p><strong>Background: </strong>Transcranial direct current stimulation (tDCS) positively affects post-stroke cognitive impairment (PSCI). However, the optimal stimulation protocol remains unclear, possibly because of the lack of objective assessment methods. Therefore, this study aims to investigate the impact of tDCS on the modulation of the excitation/inhibition (E/I) balance and its effects on brain function in patients with PSCI using transcranial magnetic stimulation (TMS) and functional near-infrared spectroscopy (fNIRS).</p><p><strong>Methods: </strong>This study is a single-centre, two-armed randomised controlled trial. A total of 40 patients with PSCI will be recruited and randomly assigned to real and sham tDCS groups in a 1:1 ratio. Both groups will receive either real or sham tDCS in addition to conventional treatment. In both groups, electrodes will be placed at the same positions, with the anode and cathode above the left and right dorsolateral prefrontal cortex, respectively. The real tDCS group will receive continuous current throughout the session, whereas the sham tDCS group will receive current generation for only the first 30 s. The treatment will consist of a 3-week intervention with one session per day, five sessions per week and 30 min per session. A 4-week follow-up will be conducted at the end of the treatment. The primary outcome is the change in Montreal cognitive assessment (MoCA) scores from baseline (T0) to immediately post-intervention (T1). Secondary outcomes include Barthel index, levels of intracortical inhibition measured by TMS and cortical activation and interhemispheric connectivity assessed by fNIRS during a Stroop task.</p><p><strong>Discussion: </strong>This study will combine TMS and fNIRS to explore the effects of tDCS on the modulation of the E/I balance and its impact on blood oxygen levels and neural activity. Our results are expected to provide a clinical reference for the development of more precise tDCS protocols.</p><p><strong>Trial registration: </strong>Chinese Clinical Trials Registry ChiCTR2300077453. Registered on November 9, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147780936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection: study protocol for a multicenter, open-label, randomized, no-treatment-controlled trial.","authors":"Jun Huang, Zehan Chen, Mingming Wang, Chenghai Yang, Anjiang Wang, Ye Chen","doi":"10.1186/s13063-026-09740-1","DOIUrl":"https://doi.org/10.1186/s13063-026-09740-1","url":null,"abstract":"<p><strong>Background: </strong>Endoscopic resection is the standard treatment for colorectal adenoma (CRA), a key precursor to colorectal cancer (CRC). However, a high rate of recurrence post-procedure poses a significant challenge for long-term CRC prevention. Growing evidence suggests gut microbial dysbiosis contributes to adenoma development and recurrence. This trial will test the hypothesis that restoring a healthy gut microbiome with fecal microbiota transplantation (FMT) can reduce the recurrence of CRA after endoscopic resection.</p><p><strong>Methods: </strong>This protocol describes a multicenter, open-label, randomized, no-treatment-controlled trial that will enroll 466 participants with CRA following endoscopic resection. Participants will be randomly assigned in a 1:1 ratio to receive either FMT or no treatment (control). The FMT intervention consists of an initial colonoscopic infusion and oral capsules, followed by oral maintenance capsules at months 3, 6, and 9. The primary outcome is the rate of CRA recurrence at the 12-month follow-up colonoscopy. Key secondary outcomes include the incidence of all polypoid lesions, changes in the gut and mucosal microbiota composition, the incidence of CRC, and a comprehensive assessment of adverse events to evaluate safety.</p><p><strong>Discussion: </strong>This trial is designed to provide high-quality evidence on the efficacy and safety of FMT for preventing CRA recurrence. The findings may support a novel, microbiome-based strategy for the secondary prevention of CRC and provide mechanistic insights into the role of the gut microbiota in colorectal carcinogenesis.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06205862. Registered on 16 January, 2024. https://clinicaltrials.gov/study/NCT06205862.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating fitness-for-use of electronic health records in ascertaining baseline characteristics and clinical outcomes in clinical trials: insights from the VESALIUS EHR demonstration project.","authors":"Pishoy Gouda, Adam J Nelson, Sudha R Raman, Laura G Qualls, Bradley G Hammill, Jyotsna Garg, Catherine P Benziger, Rekha Divakaran, Ester Kim Nilles, Keith Marsolo, Emily C O'Brien","doi":"10.1186/s13063-026-09683-7","DOIUrl":"https://doi.org/10.1186/s13063-026-09683-7","url":null,"abstract":"<p><strong>Introduction: </strong>A tremendous amount of clinical data is collected and stored in electronic health records (EHRs). Whether this data can be harnessed at scale to facilitate clinical trial conduct remains to be seen.</p><p><strong>Methods: </strong>The Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV) trial included an embedded study evaluating the fitness-for-use of EHR data to ascertain baseline demographics (age, sex, race/ethnicity, history of coronary disease, cerebrovascular disease, peripheral artery disease, heart failure, diabetes, hypertension, and atrial fibrillation), laboratory (creatinine, lipid values), and outcomes (myocardial infarction, stroke, revascularization, and heart failure) data, compared to trial data collected through a study case report form (CRF). These are described using concordance statistics (overall agreement, sensitivity, specificity, negative predictive value, positive predictive value, kappa statistic and bias).</p><p><strong>Results: </strong>The VESALIUS-CV EHR substudy included 75 participants (9 sites). For categorical baseline variables, the overall agreement between EHR and CRF data ranged between 81.3 and 98.7%, sensitivity ranged between 42.9 and 100%, specificity ranged between 50.0 and 100%, and kappa statistic ranged between 0.2 and 0.8. Identification of a history of peripheral artery disease in EHR data was poor (positive predictive value 23.1%). Of 431 continuous variables, bias was generally low but was associated with moderate imprecision, with exact matches observed in 95.8% of cases. Of a total of 20 outcome events, the overall agreement ranged between 86.7 and 100%, sensitivity ranged between 50 and 100%, specificity ranged between 86.7 and 100%, and kappa statistic ranged between 0.7 and 1.0.</p><p><strong>Conclusion: </strong>EHR data has the potential to facilitate and reduce the burden of data collection for clinical trials, but further work is required to optimize data extraction and improve accuracy.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of oral azithromycin in pregnant women living in low-middle income neighborhoods with high risk of reproductive tract infections to prevent preterm birth: study protocol of an individually randomized trial (pPAZI trial).","authors":"Bireshwar Sinha, Ratna Biswas, Neeta Dhabhai, Sushma Nangia, Nidhi Goyal, Reena Yadav, Deepak More, Debashmita Banerjee, Sidra Farooqui, Manju Puri, Uma Chandra Mouli Natchu, Arjun Dang, Leena Chatterjee, Temsunaro Rongsen-Chandola","doi":"10.1186/s13063-026-09745-w","DOIUrl":"https://doi.org/10.1186/s13063-026-09745-w","url":null,"abstract":"<p><strong>Background: </strong>India contributes to around one-fifth of all preterm births globally. Reproductive tract infections (RTIs), colonization of fetal membranes, and associated maternal inflammatory immune response are recognized as a major trigger associated with preterm birth. Azithromycin is a broad-spectrum macrolide antibiotic with anti-inflammatory properties and is commonly used for symptomatic reproductive tract infections. Evidence from African trials suggests that oral azithromycin in the antenatal period can substantially reduce preterm births in malaria holoendemic settings (where all pregnant women receive antimalarials as standard). It is unclear whether the intervention works in South Asian settings where malaria is not holoendemic.</p><p><strong>Methods: </strong>Using an individually randomized trial design, our primary study objective is to evaluate whether two doses of oral azithromycin (each dose 1 g/day for two consecutive days) compared to control (calcium 500 g/day for two consecutive days) during the antenatal period, i.e., at 20-24 weeks and at 28-32 weeks of gestation, in Indian women with high risk of reproductive tract infections can substantially prevent preterm birth and birth of other small vulnerable infants. The live newborns and their mothers will be followed up till 2 months after birth to estimate the intervention effect on neonatal sepsis, puerperal pyrexia, or sepsis in the mothers, antibiotic use during the first 2 months of birth, and cumulative incidence of phenotypic macrolide resistance. Separate independent teams will conduct the intervention delivery and outcome assessment.</p><p><strong>Discussion: </strong>In low-middle income neighborhoods in India, around half of the RTIs are often asymptomatic or unreported and contribute to preterm birth. Our approach involves screening pregnant women at risk of RTI and using azithromycin as a preventive treatment for preterm birth reduction in Indian settings. Additionally, the study will generate data on the intervention effect on child growth, overall antibiotic use, and any concern related to emerging antimicrobial resistance. If the results show a beneficial effect, they could inform policy discussions on the potential use of azithromycin as a preventative treatment for women at risk of RTIs to reduce preterm birth rates.</p><p><strong>Trial registration: </strong>The trial has been registered prospectively in Clinical Trial Registry-India # CTRI/2024/10/075570, registered on 21 October 2024 https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTE0NzM1&Enc=&userName=.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of constraint standing training on balance and gait in hemiparetic stroke patients: a single-blind randomized controlled trial protocol.","authors":"Liping Zhou, Huaide Chu, Manting Cao, Nur Arzuar Abdul Rahim, Hazwani Ahmad Yusof, Ying Hou","doi":"10.1186/s13063-026-09735-y","DOIUrl":"https://doi.org/10.1186/s13063-026-09735-y","url":null,"abstract":"<p><strong>Background: </strong>Modified Constraint-Induced Movement Therapy (mCIMT) has demonstrated significant potential in rehabilitating lower extremity motor impairments following stroke. However, mCIMT's application is often limited by the need for specialized devices to constrain the non-affected extremity and longer training duration. Constraint Standing Training (CST) is a novel variation of mCIMT that addresses these limitations by eliminating the need for constraining devices and reducing training time, thereby enhancing its feasibility for clinical implementation. Despite these advantages, the specific effects of CST on balance and gait in stroke patients remain underexplored.</p><p><strong>Methods: </strong>This study will use a randomized, controlled, single-blinded design. Fifty stroke patients in the chronic phase, with gait disabilities and the ability to stand independently, will be randomly assigned to either the CST group or a control group using a computer-generated randomization sequence. Exclusion criteria include physiological or cognitive impairments that may hinder evaluation or training. Both groups will undergo daily 1-h training sessions, five times per week, for 8 weeks. The CST group will undergo sequential standing training using shaping strategies from a single plane to multiple planes, while the control group will receive conventional intensive training, which includes balance and gait exercises commonly used in clinical practice. Assessments will be carried out at baseline (T₀), mid-intervention (T₁), post-intervention (T₂), and 1 month follow-up (T₃). The primary outcome of this trial is the Timed Up and Go (TUG) test. Secondary outcomes include the 10-Meter Walk Test, 6-Minute Walk Test, Berg Balance Scale, three-dimensional gait analysis, and surface electromyography. Missing data will be handled using multiple imputation by chained equations. Data will be analyzed using two-way repeated measures ANOVA or generalized estimating equations to determine differences and identify clinically relevant changes.</p><p><strong>Discussion: </strong>This protocol provides detailed CST methods to guide future research and clinical application. The study employs a randomized controlled trial design to robustly evaluate CST's effects on balance and gait in hemiparetic stroke patients. CST's sequential, multi-plane exercises offer a potentially practical alternative. However, larger, multi-center trials are recommended for future validation.</p><p><strong>Trial registration: </strong>This trial is registered at www.chictr.org.cn.</p><p><strong>Registration number: </strong>ChiCTR2400086282. Date of registration: 27 June 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges and strategies to improve recruitment in international, multi-centre research studies in locally recurrent rectal cancer: experience from the Locally Recurrent Rectal Cancer-Quality of Life (LRRC-QoL) study.","authors":"Niamh McKigney, Julie Croft, Galina Velikova, Julia M Brown, Deena P Harji","doi":"10.1186/s13063-025-09264-0","DOIUrl":"https://doi.org/10.1186/s13063-025-09264-0","url":null,"abstract":"<p><strong>Background: </strong>Locally recurrent rectal cancer (LRRC) is an emerging area for research; however, it represents significant challenges as a relatively rare form of advanced pelvic malignancy, from both a recruitment and study setup and delivery perspective. To date, there have been relatively few published trials in this setting. High-quality, multi-centre, prospective studies could offer helpful insights regarding the challenges associated with delivering studies in rare disease settings such as LRRC, and how to effectively address them.</p><p><strong>Methods: </strong>The Locally Recurrent Rectal Cancer-Quality of Life (LRRC-QoL) study is an international, multi-centre, mixed-methods study of health-related quality of life (HrQoL) in LRRC. The International Surgical Trials Toolkit was utilised as a guideline in navigating site setup processes and to describe the challenges encountered during this study. A modified Quintet Recruitment Intervention (QRI) was used as a framework to identify recruitment challenges and drive improvements.</p><p><strong>Results: </strong>Overall, 227 patients were recruited to the LRRC-QoL study across 14 countries. Significant challenges were encountered during site setup, including issues related to legal agreements which were further complicated by Brexit, expenses related to translation, and requirements for multiple ethical approvals. Delays during study setup and recruitment challenges occurred due to the COVID-19 pandemic. Several strategies were identified through the modified QRI with a positive impact on recruitment. Recruitment pathways were refined to a more streamlined, centralised approach, facilitated by verbal consent to contact. Recruitment rates also improved with the introduction of multiple options for participation, including traditional paper-based methods, online, and via telephone. Patient information leaflets were refined following patient and public involvement (PPI) work.</p><p><strong>Conclusions: </strong>Several approaches identified during the LRRC-QoL study should be considered in the development of future studies and trials recruiting patients with LRRC. These include undertaking PPI during study development, identifying flexible recruitment strategies which complement sites' existing clinical processes, and partnering with existing collaborative networks. Study registration The LRRC-QoL study registration reference: ISRCTN13692671 (https://doi.org/10.1186/ISRCTN13692671).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}