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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

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

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

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

Combined robot motor assistance with neural circuit-based virtual reality (NeuCir-VR) lower extremity rehabilitation training in patients after stroke: a study protocol for a single-centre randomised controlled trial
Introduction Improving lower extremity motor function is the focus and difficulty of post-stroke rehabilitation treatment. More recently, robot-assisted and virtual reality (VR) training are commonly used in post-stroke rehabilitation and are considered feasible treatment methods. Here, we developed a rehabilitation system combining robot motor assistance with neural circuit-based VR (NeuCir-VR) rehabilitation programme involving procedural lower extremity rehabilitation with reward mechanisms, from muscle strength training, posture control and balance training to simple and complex ground walking training. The study aims ...
Source: BMJ Open - December 23, 2022 Category: General Medicine Authors: Zhou, Z.-Q., Hua, X.-Y., Wu, J.-J., Xu, J.-J., Ren, M., Shan, C.-L., Xu, J.-G. Tags: Open access, Rehabilitation medicine Source Type: research

Effects of whole-body vibration training on lower limb motor function and neural plasticity in patients with stroke: protocol for a randomised controlled clinical trial
This study has been approved by the Shanghai University of Sport Research Ethics Committee (102772021RT067) and will provide data on the effects of WBVT relative to RRT in terms of the improvement of stroke patients’ lower limb motor function and neural plasticity. The results of this study will be disseminated via publications in peer-reviewed journals and presentations at international conference. Trial registration number ChiCTR2200055143.
Source: BMJ Open - June 28, 2022 Category: General Medicine Authors: Zhang, M., Wei, J., Wu, X. Tags: Open access, Sports and exercise medicine Source Type: research

Structured follow-up pathway to support people after transient ischaemic attack and minor stroke (SUPPORT TIA): protocol for a feasibility study and process evaluation
Introduction People who experience transient ischaemic attack (TIA) and minor stroke have limited follow-up despite rapid specialist review in hospital. This means they often have unmet needs and feel abandoned following discharge. Care needs after TIA/minor stroke include information provision (diagnosis and stroke risk), stroke prevention (medication and lifestyle change) and holistic care (residual problems and return to work or usual activities). This protocol describes a feasibility study and process evaluation of an intervention to support people after TIA/minor stroke. The study aims to assess the feasibility and ac...
Source: BMJ Open - June 16, 2022 Category: General Medicine Authors: Turner, G. M., Jones, R., Collis, P., Patel, S., Jowett, S., Tearne, S., Foy, R., Atkins, L., Mant, J., Calvert, M. Tags: Open access, Cardiovascular medicine Source Type: research

Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb post Stroke (RHOMBUS II): protocol of a feasibility randomised controlled trial
Introduction Upper limb (UL) rehabilitation is most effective early after stroke, with higher doses leading to improved outcomes. For the stroke survivor, the repetition may be monotonous. For clinicians, providing a clinically meaningful level of input can be challenging. As such, time spent engaged in UL activity among subacute stroke survivors remains inadequate. Opportunities for the stroke survivor to engage with UL rehabilitation in a safe, accessible and engaging way are essential to improving UL outcomes following stroke. The NeuroBall is a non-immersive virtual reality (VR) digital system designed for stroke rehab...
Source: BMJ Open - June 7, 2022 Category: General Medicine Authors: Kilbride, C., Warland, A., Stewart, V., Aweid, B., Samiyappan, A., Ryan, J., Butcher, T., Athanasiou, D. A., Baker, K., Singla-Buxarrais, G., Anokye, N., Pound, C., Gowing, F., Norris, M. Tags: Open access, Rehabilitation medicine Source Type: research

Multicentre collection of uniform data on patients hospitalised for transient ischaemic attack or stroke in the Philippines: the Philippine Neurological Association One Database-Stroke (PNA1DB-Stroke) protocol
Introduction For scientific advances to translate into improved patient outcomes, systems of care must be in place to facilitate delivery of care. There is scarce information on quality of care and clinical outcome in our stroke patients. We aim to collect uniform data from patients with first or recurrent transient ischaemic attack (TIA) or ischaemic or haemorrhagic stroke to determine in-patient caseload, patient profile, types of diagnostic and therapeutic procedures, outcomes and overall quality of care among patients hospitalised for acute stroke in the Philippines. Methods and analysis This multicentre observational...
Source: BMJ Open - May 24, 2022 Category: General Medicine Authors: Philippine Neurological Association One Database - Stroke, Disease Study Management Group, Gan, Alvarez, Canete, Co, Collantes, Escabillas, Hiyadan, Juangco, Lokin, Macrohon-Valdez, Punsalan, Sarapuddin, Picar, Pascual V Tags: Open access, Neurology Source Type: research

Calligraphy-based rehabilitation exercise for improving the upper limb function of stroke patients: protocol for an evaluator-blinded randomised controlled trial
This study aims to design a randomised controlled trial to assess the effect of a customised CCH-based exercise for poststroke rehabilitation of upper limb dysfunction. Methods and analysis A single-blinded randomised controlled trial will be conducted on 60 stroke patients. The patients will be randomly allocated into three groups: (1) conventional occupational therapy (COT) group, (2) COT+CCH group, (3) COT+Graded Repetitive Arm Supplementary Program (GRASP) group. For the COT group, patients will receive COT treatment of 1 hour/day. For the COT+CCH group, patients will receive 30 mins COT treatment and 30 mins CCH trai...
Source: BMJ Open - May 13, 2022 Category: General Medicine Authors: Wu, X., Zhang, Q., Qiao, J., Chen, N., Wu, X. Tags: Open access, Rehabilitation medicine Source Type: research

Healing Right Way: study protocol for a stepped wedge cluster randomised controlled trial to enhance rehabilitation services and improve quality of life in Aboriginal Australians after brain injury
This study will test the impact of a research-informed culturally secure intervention model for Aboriginal people with brain injury. Methods and analysis Design: Stepped wedge cluster randomised control trial design; intervention sequentially introduced at four pairs of healthcare sites across Western Australia at 26-week intervals. Recruitment: Aboriginal participants aged ≥18 years within 4 weeks of an acute stroke or traumatic brain injury. Intervention: (1) Cultural security training for hospital staff and (2) local, trial-specific, Aboriginal Brain Injury Coordinators supporting participants. Primary outcome: Qual...
Source: BMJ Open - September 28, 2021 Category: General Medicine Authors: Armstrong, E., Coffin, J., Hersh, D., Katzenellenbogen, J. M., Thompson, S., Flicker, L., McAllister, M., Cadilhac, D. A., Rai, T., Godecke, E., Hayward, C., Hankey, G. J., Drew, N., Lin, I., Woods, D., Ciccone, N. Tags: Open access, Health services research Source Type: research

Design, methodology and baseline characteristics of Tai Chi and its protective effect against ischaemic stroke risk in an elderly community population with risk factors for ischaemic stroke: a randomised controlled trial
Introduction Controlling risk factors with regular exercise is effective and cost-effective for the primary prevention of ischaemic stroke. As a traditional Chinese form of exercise, Tai Chi might be beneficial in decreasing ischaemic stroke, but the evidence remains insufficient. We hypothesise that elderly community adults with risk factors for ischaemic stroke will decrease their ischaemic stroke risk by improving cerebral haemodynamic parameters, cardiopulmonary function, motor function, plasma risk indices, physical parameters or psychological outcomes after receiving 12 weeks of regular Tai Chi training compared...
Source: BMJ Open - December 23, 2015 Category: Journals (General) Authors: Zheng, G., Zheng, X., Li, J., Duan, T., Qi, D., Ling, K., He, J., Chen, L. Tags: Open access, Public health, Sports and exercise medicine Protocol Source Type: research

A randomised controlled trial to compare the clinical and cost-effectiveness of prism glasses, visual search training and standard care in patients with hemianopia following stroke: a protocol
This study has been developed and supported by the UK Stroke Research Network Clinical Studies Group working with service users. Multicentre ethical approval was obtained through the North West 6 Research ethics committee (Reference 10/H1003/119). The trial is funded by the UK Stroke Association. Trial Registration: Current Controlled Trials ISRCTN05956042. Dissemination will consider usual scholarly options of conference presentation and journal publication in addition to patient and public dissemination with lay summaries and articles. Trial Registration Current Controlled Trials ISRCTN05956042.
Source: BMJ Open - July 17, 2014 Category: Journals (General) Authors: Rowe, F. J., Barton, P. G., Bedson, E., Breen, R., Conroy, E. J., Cwiklinski, E., Dodridge, C., Drummond, A., Garcia-Finana, M., Howard, C., Johnson, S., MacIntosh, C., Noonan, C. P., Pollock, A., Rockliffe, J., Sackley, C., Shipman, T., VISION (vision im Tags: Open access, Neurology, Ophthalmology, Rehabilitation medicine Protocol Source Type: research