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Total 93 results found since Jan 2013.

Exoskeletal wearable robot on ambulatory function in patients with stroke: a protocol for an international, multicentre, randomised controlled study
This study is an international, multicentre, randomised controlled study at five institutions with a total of 150 patients with subacute stroke. Participants will be randomised into two groups (75 patients in the robot-assisted gait training (RAGT) group and 75 patients in the control group). The gait training will be performed with a total of 20 sessions (60 min/session); 5 sessions a week for 4 weeks. The RAGT group will receive 30 min of gait training using an exoskeleton (ANGEL LEGS M20, Angel Robotics) and 30 min of conventional gait training, while the control group will receive 60 min conventional gait training. In ...
Source: BMJ Open - August 11, 2023 Category: General Medicine Authors: Chang, W. H., Kim, T.-W., Kim, H. S., Hanapiah, F. A., Kim, D. H., Kim, D. Y. Tags: Open access, Rehabilitation medicine Source Type: research

Bedtime versus morning use of antihypertensives in frail continuing care residents (BedMed-Frail): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial
Introduction BedMed-Frail explores risks and benefits of switching antihypertensives from morning to bedtime in a frail population at greater risk of hypotensive adverse effects. Methods and analysis Design: Prospective parallel randomised, open-label, blinded end-point trial. Participants: Hypertensive continuing care residents, in either long-term care or supportive living, who are free from glaucoma, and using ≥1 once daily antihypertensive. Setting: 16 volunteer continuing care facilities in Alberta, Canada, with eligible residents identified using electronic health claims data. Intervention: All non-opted out elig...
Source: BMJ Open - August 1, 2023 Category: General Medicine Authors: Garrison, S. R., Youngson, E., Perry, D. A., Campbell, F. N., Kolber, M. R., Korownyk, C., Allan, G. M., Green, L., Bakal, J. Tags: Open access, Cardiovascular medicine Source Type: research

TeleRehabilitation with Aims to Improve Lower extremity recovery in community-dwelling individuals who have had a stroke: protocol for a multisite, parallel group, assessor-blinded, randomised attention-controlled trial
Introduction Telerehabilitation is an accessible service delivery model that may support innovative lower extremity rehabilitation programmes that extend the stroke recovery continuum into the community. Unfortunately, there is limited evidence on the provision of exercises for lower extremity recovery after stroke delivered using telerehabilitation. In response, we developed the TeleRehabilitation with Aims to Improve Lower extremity recovery poststroke (TRAIL) programme, a 4-week progressive exercise and self-management intervention delivered synchronously using video-conferencing technology. Our primary hypothesis is th...
Source: BMJ Open - July 19, 2023 Category: General Medicine Authors: Sakakibara, B. M., Wiley, E., Barclay, R., Bayley, M., Davis, J. C., Eng, J. J., Harris, A., Inness, E. L., MacKay-Lyons, M., Monaghan, J., Pollock, C., Pooyania, S., Schneeberg, A., Teasell, R., Yao, J., Tang, A. Tags: Open access, Health services research Source Type: research

Effects of intensive lipid lowering compared with moderate-intensity lipid lowering on coronary atherosclerotic plaque phenotype and major adverse cardiovascular events in adults with low to intermediate 10-year ASCVD risk (ILLUMINATION study): protocol for a multicentre, open-label, blinded-endpoint, randomised controlled trial
Introduction Current guidelines recommend moderate-intensity lipid lowering (low-density lipoprotein cholesterol, LDL-C of <2.6 mmol/L or 30%–49% reduction from the baseline) for patients with intermediate 10-year atherosclerotic cardiovascular disease (ASCVD) risk. The effects of intensive lipid lowering (LDL-C of <1.8 mmol/L) on coronary atherosclerotic plaque phenotype and major adverse cardiovascular events (MACE) in adults with both non-obstructive coronary artery disease (CAD) and low to intermediate 10-year ASCVD risk remain uncertain. Methods and analysis Intensive Lipid-lowering for Plaque and Major A...
Source: BMJ Open - June 5, 2023 Category: General Medicine Authors: Zheng, J., Hou, Z., Yuan, J., Zhao, X., Wang, Y., Li, J., Zhang, W., Dou, K., Lu, B. Tags: Open access, Cardiovascular medicine Source Type: research

Correction: Stroke prevention of thoracoscopic left atrial appendage clipping in patients with non-valvular atrial fibrillation at high risk of stroke and bleeding: study protocol for a non-randomised controlled clinical trial
This article has been corrected since it was published online. The affiliation numbers 1 and 2 have been merged and updated to "Department of Cardiac Surgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China".
Source: BMJ Open - June 1, 2023 Category: General Medicine Tags: Open access Correction Source Type: research

Effect of multicomponent rehabilitation on independence and functioning in elderly patients with common age-associated diseases: protocol for a scoping review (REHOLD)
Introduction Elderly patients after hospitalisation for acute events on account of age-related diseases (eg, joint or heart valve replacement surgery) are often characterised by a remarkably reduced functional health. Multicomponent rehabilitation (MR) is considered an appropriate approach to restore the functioning of these patients. However, its efficacy in improving functioning-related outcomes such as care dependency, activities of daily living (ADL), physical function and health-related quality of life (HRQL) remains unclarified. We outline the research framework of a scoping review designed to map the available evide...
Source: BMJ Open - May 18, 2023 Category: General Medicine Authors: Baritello, O., Stein, H., Wolff, L. L., Hamann, M., Völler, H., Salzwedel, A. Tags: Open access, Rehabilitation medicine Source Type: research

Efficacy and safety of carbon dioxide insufflation for brain protection for patients undergoing planned left-sided open heart valve surgery: protocol for a multicentre, placebo-controlled, blinded, randomised controlled trial (the CO2 Study)
Introduction Brain injury is common following open heart valve surgery. Carbon dioxide insufflation (CDI) has been proposed to reduce the incidence of brain injury by reducing the number of air microemboli entering the bloodstream in surgery. The CO2 Study will evaluate the efficacy and safety of CDI in patients undergoing planned left-sided open heart valve surgery. Methods and analysis The CO2 Study is a multicentre, blinded, placebo-controlled, randomised controlled trial. Seven-hundred and four patients aged 50 years and over undergoing planned left-sided heart valve surgery will be recruited to the study, from at lea...
Source: BMJ Open - May 17, 2023 Category: General Medicine Authors: Todd, R., Rogers, C. A., Pufulete, M., Culliford, L., Pretorius, P., Voets, N., Akowuah, E., Sayeed, R., Lazaroo, M., Kaur, S., Angelini, G. D., Gibbison, B. Tags: Open access, Surgery Source Type: research

Impact of polyethylene glycol loxenatide on cardiovascular outcomes in patients with type 2 diabetes: study protocol for a multicentre, randomised, double-blind, placebo-controlled trial (BALANCE-3)
This study is a multicentre, randomised, double-blind, placebo-controlled trial. Patients with T2DM who fulfilled the inclusion criteria were randomly divided to receive weekly administration of either PEG-Loxe 0.2 mg or placebo (1:1 ratio). The randomisation was stratified according to utilisation of sodium-glucose cotransporter 2 inhibitors, history of CV disease and body mass index. The research period is expected to be 3 years, with a 1-year recruitment period and a 2-year follow-up period. The primary outcome is the occurrence of the first MACE, described as CV death, non-fatal myocardial infarction or non-fatal strok...
Source: BMJ Open - May 16, 2023 Category: General Medicine Authors: Xie, Y., Kuang, J., Li, Q., Hong, T., Ji, L., Kong, Y., Duan, Y., Chen, L. Tags: Open access, Diabetes and Endocrinology Source Type: research

Multimodal individualised intervention to prevent functional decline after stroke: protocol of a randomised controlled trial on long-term follow-up after stroke (LAST-long)
Introduction Multimodal interventions have emerged as new approaches to provide more targeted intervention to reduce functional decline after stroke. Still, the evidence is contradictory. The main objective of the Life After Stroke (LAST)-long trial is to investigate if monthly meetings with a stroke coordinator who offers a multimodal approach to long-term follow-up can prevent functional decline after stroke. Methods and analysis LAST-long is a pragmatic single-blinded, parallel-group randomised controlled trial recruiting participants living in six different municipalities, admitted to four hospitals in Norway. The pat...
Source: BMJ Open - May 10, 2023 Category: General Medicine Authors: Askim, T., Hokstad, A., Bergh, E., Dohl, O., Ellekjaer, H., Ihle-Hansen, H., Indredavik, B., Leer, A. S. M., Lydersen, S., Saltvedt, I., Seljeseth, Y., Thommessen, B. Tags: Open access, Rehabilitation medicine Source Type: research

FIND Stroke Recovery Study (FIND): rationale and protocol for a longitudinal observational cohort study of trajectories of recovery and biomarkers poststroke
Introduction Comprehensive studies mapping domain-specific trajectories of recovery after stroke and biomarkers reflecting these processes are scarce. We, therefore, initiated an exploratory prospective observational study of stroke cases with repeated evaluation, the FIND Stroke Recovery Study. We aim to capture trajectories of recovery from different impairments, including cognition, in combination with broad profiling of blood and imaging biomarkers of the recovery. Methods and analysis We recruit individuals with first-ever stroke at the stroke unit at the Sahlgrenska University Hospital, Sweden, to FIND. The inclusio...
Source: BMJ Open - May 10, 2023 Category: General Medicine Authors: Brännmark, C., Klasson, S., Stanne, T. M., Samuelsson, H., Alt Murphy, M., Sunnerhagen, K. S., Aberg, N. D., Jalnefjord, O., Björkman-Burtscher, I., Jood, K., Tatlisumak, T., Jern, C. Tags: Open access, Neurology Source Type: research

Atorvastatin and the influence on postoperative atrial fibrillation after surgical aortic valve replacement (STARC) in adults at Odense University Hospital, Denmark: study protocol for a randomised controlled trial
Introduction Atrial fibrillation (AF) is the most common postoperative complication after surgical aortic valve replacement (SAVR) and occurs in up to 50% of the patients. Development of postoperative AF (POAF) is associated with a 2–3 fold increased risk of adverse events, including stroke, myocardial infarction and death. Several studies have implied that prophylactic Atorvastatin therapy could prevent POAF in patients undergoing coronary artery bypass graft. These studies suggest that Atorvastatin has rapid and significant pleiotropic actions that reduce the risk of POAF. However, prophylactic treatment with stati...
Source: BMJ Open - May 10, 2023 Category: General Medicine Authors: Krasniqi, L., Brandes, A., Mortensen, P. E., Dahl, J. S., Gerke, O., Ali, M., Riber, L. P. S. Tags: Open access, Cardiovascular medicine Source Type: research

Effect and safety of C7 neurotomy at the intervertebral foramen in patients with chronic poststroke aphasia: a multicentre, randomised, controlled study protocol
This study will explore the efficacy of NC7 at the intervertebral foramen for improving chronic poststroke aphasia. Methods and analysis This study protocol reports a multicentre, randomised, assessor-blinded active-controlled trial. A total of 50 patients with chronic poststroke aphasia for over 1 year and with a aphasia quotient calculated by Western Aphasia Battery Aphasia Quotient (WAB-AQ) score below 93.8 will be recruited. Participants will be randomly assigned to 1 of 2 groups (25 individuals each) to receive NC7 plus intensive speech and language therapy (iSLT), or iSLT alone programme. The primary outcome is the ...
Source: BMJ Open - May 2, 2023 Category: General Medicine Authors: Li, T., Feng, J., Hu, R., Lv, M., Chang, W., Ma, X., Qi, W., Zhang, Y., Chen, X., Ding, L., Gu, Y., Xu, W. Tags: Open access, Neurology Source Type: research

Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal trial
This study was approved by the Ethics Committee of the Local Health Unit of Matosinhos (Ref. 75/CES/JAS). Written informed consent will be required from all the participants; data protection and confidentiality will be also ensured. The findings of this project are expected to be submitted for publication in scientific articles, and the main results will be presented at relevant scientific meetings. Trial registration number NCT05369637.
Source: BMJ Open - April 28, 2023 Category: General Medicine Authors: Goncalves, M., Lima, M. J., Fonseca, A., Duque, C., Costa, A. R., Cruz, V. T. Tags: Open access, Neurology Source Type: research

Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study
We describe the protocol of a randomised clinical trial that aims to evaluate the efficiency and effectiveness of an intensive multidisciplinary follow-up of patients compared with standard care. Methods and analysis The DiVa study is a randomised, prospective, controlled, multicentre trial including patients >18 years old with a first or recurrent stroke (ischaemic or haemorrhagic) or TIA, or a type I or II MI, managed in one of the participating hospitals of the study area, with a survival expectancy >12 months. Patients will be randomised with an allocation ratio of 1:1 in two parallel groups: one group assigned ...
Source: BMJ Open - April 26, 2023 Category: General Medicine Authors: Bejot, Y., Soilly, A.-L., Bardou, M., Duloquin, G., Pommier, T., Laurent, G., Cottin, Y., Vadot, L., Adam, H., Boulin, M., Giroud, M. Tags: Open access, Cardiovascular medicine Source Type: research

Transcranial direct current stimulation combined with bodyweight support-tai chi footwork for motor function of stroke survivors: a study protocol of randomised controlled trial
This study will be an assessor-blinded randomised controlled trial involving 12-week intervention and 6-month follow-up. One hundred and thirty-five individuals with stroke will be randomly divided in a ratio of 1:1:1 into three groups. Control group A, control group B and intervention group C will receive tDCS and conventional rehabilitation programmes (CRPs), BWS-TC and CRP, tDCS-BWS-TC and CRP for 12 weeks, respectively. The primary outcome measures will include the efficacy (Fugl-Meyer Assessment), acceptability and safety of these interventions. The secondary outcome measures will include balance ability (ie, limits o...
Source: BMJ Open - March 7, 2023 Category: General Medicine Authors: Lai, M.-h., Xu, H.-c., Huang, M.-c., Lu, Y., Yang, K., Jiang, L.-m., Yu, X.-m. Tags: Open access, Rehabilitation medicine Source Type: research