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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

The Taking Charge After Stroke (TaCAS) study protocol: a multicentre, investigator-blinded, randomised controlled trial comparing the effect of a single Take Charge session, two Take Charge sessions and control intervention on health-related quality of life 12 months after stroke for non-Maori, non-Pacific adult New Zealanders discharged to community living
Introduction Stroke is one of the leading causes of disability worldwide. Recent data support the possibility that person-centred, self-management interventions can reduce dependence after stroke. However, there is limited information on the generalisability and optimum dose of these interventions. Methods The Taking Charge After Stroke (TaCAS) study is a multicentre, investigator-blinded, randomised controlled trial recruiting 400 participants following acute stroke from seven hospitals in New Zealand. All patients discharged to community living who have ongoing symptoms at time of discharge (modified Rankin scale>0) ...
Source: BMJ Open - June 1, 2017 Category: General Medicine Authors: Fu, V. W. Y., Weatherall, M., McNaughton, H. Tags: Open access, Rehabilitation medicine Protocol Source Type: research

Effects of a social participation-focused virtual reality intervention for community-dwelling stroke survivors with physical disabilities: a randomised controlled trial protocol
Introduction Studies show that stroke survivors encounter physical and psychological limitations that restrict their participation in social and community activities. Systematic reviews have yielded inconclusive evidence regarding the effectiveness of different interventions intended to support stroke survivors’ social participation. Recent advances in virtual reality technology may offer promising solutions, although the optimal approach to enhance social participation among stroke survivors is yet to be determined. This trial aims to develop and evaluate the effectiveness of a social participation-focused virtual r...
Source: BMJ Open - July 5, 2022 Category: General Medicine Authors: Chau, J. P. C., Lo, S. H. S., Lau, A. Y. L., Lee, V. W. Y., Choi, K. C., Kwok, E. C. F., Thompson, D. R. Tags: Open access, Rehabilitation medicine Source Type: research

Person-centred care transitions for people with stroke: study protocol for a feasibility evaluation of codesigned care transition support
This study protocol describes the evaluation of a feasibility study using a non-randomised controlled design. The codesigned care transition support includes patient information using videos, leaflets and teach back; what-matters-to me dialogue; a coordinated rehabilitation plan; bridged e-meeting; and a message system for cross-organisational collaboration. Patients with stroke, first time or recurrent, who are to be discharged home from hospital and referred to a rehabilitation team in primary healthcare for continued rehabilitation in the home will be included. One week after stroke, data will be collected on the primar...
Source: BMJ Open - December 23, 2021 Category: General Medicine Authors: Flink, M., Lindblom, S., Tistad, M., Laska, A. C., Bertilsson, B. C., Wärlinge, C., Hasselström, J., Elf, M., von Koch, L., Ytterberg, C. Tags: Open access, Neurology Source Type: research

Secondary prevention and cognitive function after stroke: a study protocol for a 5-year follow-up of the ASPIRE-S cohort
Introduction Cognitive impairment is common following stroke and can increase disability and levels of dependency of patients, potentially leading to greater burden on carers and the healthcare system. Effective cardiovascular risk factor control through secondary preventive medications may reduce the risk of cognitive decline. However, adherence to medications is often poor and can be adversely affected by cognitive deficits. Suboptimal medication adherence negatively impacts secondary prevention targets, increasing the risk of recurrent stroke and further cognitive decline. The aim of this study is to profile cognitive f...
Source: BMJ Open - March 27, 2017 Category: Journals (General) Authors: Rohde, D., Williams, D., Gaynor, E., Bennett, K., Dolan, E., Callaly, E., Large, M., Hickey, A. Tags: Open access, Cardiovascular medicine, Epidemiology Protocol Source Type: research

Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol
Introduction Stroke is a serious public health problem, given it is a major cause of disability worldwide despite the spread of recanalisation therapies. Enhancement of brain plasticity with stem cell administration is a promising innovative therapy to reduce sequelae in these patients. Methods and analysis We have developed a phase IIb, multicentre, randomised, double-blind, placebo-controlled clinical trial protocol to evaluate the safety and efficacy of intravenous administration of allogeneic adipose tissue-derived mesenchymal stem cells (AD-MSCs) in patients with acute ischaemic stroke, concurrently with conventional...
Source: BMJ Open - August 9, 2021 Category: General Medicine Authors: de Celis-Ruiz, E., Fuentes, B., Moniche, F., Montaner, J., Borobia, A. M., Gutierrez-Fernandez, M., Diez-Tejedor, E. Tags: Open access, Neurology Source Type: research

Efficacy and safety of human-derived neural stem cell in patients with ischaemic stroke: study protocol for a randomised controlled trial
Introduction Stroke is the most common cause of neurological disability in adults worldwide. Neural stem cell (NSC) transplantation has shown promising results as a treatment for stroke in animal experiments. The pilot investigation of stem cells in stroke phase 1 and phase 2 trials showed that transplantation of the highest dose (20 million cells) was well tolerated. Preliminary clinical benefits have also been observed. However, the trials were open-label and had a small sample size. Furthermore, human NSCs (hNSCs) were intracerebrally implanted, and some serious adverse events were considered to be related to the surgic...
Source: BMJ Open - November 8, 2022 Category: General Medicine Authors: Xie, C., Wang, K., Peng, J., Jiang, X., Pan, S., Wang, L., Wu, Y., Guan, Y. Tags: Open access, Neurology Source Type: research

Corticocortical paired associative stimulation for treating motor dysfunction after stroke: study protocol for a randomised sham-controlled double-blind clinical trial
This study protocol aims to examine the corticocortical paired associative stimulation (ccPAS) for inducing synaptic plasticity to rescue the paralysed after stroke. Methods and analysis The current study is designed as a 14-week double-blind randomised sham-controlled clinical trial, composed of 2-week intervention and 12-week follow-up. For the study, 42 patients who had a stroke aged 40–70 will be recruited, who are randomly assigned either to the ccPAS intervention group, or to the control group at a 1:1 ratio, hence an equal number each. In the intervention group, ccPAS is practised in conjunction with the conv...
Source: BMJ Open - January 13, 2022 Category: General Medicine Authors: Duan, Y.-J., Hua, X.-Y., Zheng, M.-X., Wu, J.-J., Xing, X.-X., Li, Y.-L., Xu, J.-G. Tags: Open access, Rehabilitation medicine Source Type: research

Effect of occupational therapy home visit discharge planning on participation after stroke: protocol for the HOME Rehab trial
This study is approved by the Alfred Health Human Research Ethics Committee and site-specific ethics approval has been obtained at all participating sites. Results of the main trial and the secondary endpoint of cost-effectiveness will be submitted for publication in peer-reviewed journals Trial registration number ACTRN12618001360202
Source: BMJ Open - July 5, 2021 Category: General Medicine Authors: Lannin, N. A., Clemson, L., Drummond, A., Stanley, M., Churilov, L., Laver, K., O'Keefe, S., Cameron, I., Crotty, M., Usherwood, T., Andrew, N. E., Jolliffe, L., Cadilhac, D. A. Tags: Open access, Rehabilitation medicine 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

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