scholarly journals The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial

2020 ◽  
Vol 12 ◽  
pp. 117957351989947
Author(s):  
Nima Ahmed ◽  
Vitor A Queiroz Mauad ◽  
Olga Gomez-Rojas ◽  
Ammu Sushea ◽  
Gelanys Castro-Tejada ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Ischemic Stroke ◽  
The United States ◽  
Functional Independence ◽  
Recovery Phase ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
The Impact ◽  
Be The Change

Background and rationale: Stroke is considered the most common cause of adult disability. Intensive rehabilitation protocols outperform nonintensive counterparts. The subacute stroke phase represents a potential window to recovery. Virtual reality (VR) has been shown to provide a more stimulating environment, allowing for increased patient compliance. However, the quality of current literature comparing VR with standard therapies is limited. Our aim is to measure the impact of VR versus standard therapy on the recovery of the upper limb motor function in patients with stroke in the early subacute recovery phase. Method: This is a randomized, controlled trial that will assign 262 patients to tailor-made standard rehabilitation (TMSR) or TMSR plus immersive VR device. The trial will be conducted in an urban rehabilitation clinic in the United States with expertise in the management of poststroke patients. Patients will be 18 to 70 years of age and in the early subacute period (30-90 days post ischemic stroke). The primary outcome will be the change of Fugl-Meyer Assessment—Upper Extremity (FMA-UE) score, measured at baseline and 13 weeks after randomization. The secondary outcome will be the change in the UK Functional Independence Measure and Functional Assessment Measure (UK FIM-FAM) score at the same time points. Discussion: If the use of VR in the rehabilitation of patients with stroke proves to have a significant impact on their motor recovery, it will constitute an extremely important step into decreasing the functional impairment associated with stroke and the related health care expense burden.

scholarly journals The Impact of the mKidney mHealth System on Live Donor Follow-Up Compliance: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Macey L Henderson ◽  
Alvin G Thomas ◽  
Ann K Eno ◽  
Madeleine M Waldram ◽  
Jaclyn Bannon ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
The United States ◽  
Secondary Outcome ◽  
Hospital Level ◽  
Process Data ◽  
Randomized Controlled ◽  
The Impact

BACKGROUND Every year, more than 5500 healthy people in the United States donate a kidney for the medical benefit of another person. The Organ Procurement and Transplantation Network (OPTN) requires transplant hospitals to monitor living kidney donors (LKDs) for 2 years postdonation. However, the majority (115/202, 57%) of transplant hospitals in the United States continue to fail to meet nationally mandated requirements for LKD follow-up. A novel method for collecting LKD follow-up is needed to ease both the transplant hospital-level and patient-level burden. We built mKidney—a mobile health (mHealth) system designed specifically to facilitate the collection and reporting of OPTN-required LKD follow-up data. The mKidney mobile app was developed on the basis of input elicited from LKDs, transplant providers, and thought leaders. OBJECTIVE The primary objective of this study is to evaluate the impact of the mKidney smartphone app on LKD follow-up rates. METHODS We will conduct a two-arm randomized controlled trial (RCT) with LKDs who undergo LKD transplantation at Methodist Specialty and Transplant Hospital in San Antonio, Texas. Eligible participants will be recruited in-person by a study team member at their 1-week postdonation clinical visit and randomly assigned to the intervention or control arm (1:1). Participants in the intervention arm will receive the mHealth intervention (mKidney), and participants in the control arm will receive the current standard of follow-up care. Our primary outcome will be policy-defined complete (all components addressed) and timely (60 days before or after the expected visit date) submission of LKD follow-up data at required 6-month, 1-year, and 2-year visits. Our secondary outcome will be hospital-level compliance with OPTN reporting requirements at each visit. Data analysis will follow the intention-to-treat principle. Additionally, we will collect quantitative and qualitative process data regarding the implementation of the mKidney system. RESULTS We began recruitment for this RCT in May 2018. We plan to enroll 400 LKDs over 2 years and follow participants for the 2-year mandated follow-up period. CONCLUSIONS This pilot RCT will evaluate the impact of the mKidney system on rates of LKD and hospital compliance with OPTN-mandated LKD follow-up at a large LKD transplant hospital. It will provide valuable information on strategies for implementing such a system in a clinical setting and inform effect sizes for future RCT sample size calculations. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/11000

Immersive Virtual Reality Improves Labor and Delivery Experience for Women: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Elif Gizem Carus ◽  
Nazli Albayrak ◽  
Selen Gur Ozmen ◽  
Halit Mert Bildirici
Keyword(s):  
Virtual Reality ◽  
Patient Satisfaction ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Immersive Virtual Reality ◽  
Labor And Delivery ◽  
Control Groups ◽  
Randomized Controlled ◽  
Pain Scores ◽  
And Control

Abstract Objective: To evaluate the effectiveness of immersive Virtual Reality (VR) in laboring women on patient satisfaction as a distractive tool and pain relief.Methods: Randomized, controlled clinical trial with 42 laboring women allocated to VR intervention and control groups. Among the VR group, patient satisfaction with the use of VR was assessed by a Virtual Reality Satisfaction Survey and questioning whether they would choose VR in future labor. As a primary outcome patient satisfaction scores regarding the overall labor and delivery experience were compared between the two groups. A secondary outcome was pain assessed by a visual pain rating scale in the early and active phases of labor in both groups. Psychometric information was also collected from participants in each group using Beck Anxiety Inventory and Beck Depression Inventory. Results: We observed a high level of patient satisfaction with the use of immersive VR during labor. The survey revealed a mean satisfaction score of 89.6 ± 10.8 out of a maximum of 100. 20 out of 21 (95%) women in the VR group stated that they would like to use VR again in future labor. VR improved pain scores in early labor and contributed positively to overall labor and delivery experience. The mean pain score pre-VR was 2.6±1.2 compared to 2.0±1.3, post-VR, respectively (p<0.01). Anxiety and depression scores were similar in the intervention and control groups (p=0.103, p=0.13, respectively). Conclusion: Immersive VR application during labor was feasible and associated with higher patient satisfaction based on our study. VR also improved pain scores in early labor before epidural placement. Immersive VR may find a place as an adjunct in Labor and Delivery Units to improve the lengthy labor experience for women. Larger studies are needed to confirm these observations. Trial Registration: ClinicalTrials.gov: NCT05032456 / 02/09/2021https://clinicaltrials.gov/ct2/show/NCT05032456

Efficacy of Chinese Herbal Medicine Jiangniaosuan Formula for Treatment of Hyperuricemia: Study Protocol For A Double-Blinded Non-Inferiority Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Yafang Guo ◽  
Hong Lu ◽  
Jing Gan ◽  
Dongdong Li ◽  
Jiandong Gao ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Serum Uric Acid Level ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
To Receive ◽  
Be The Change

Abstract Background: Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.Methods: A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine i.e., febuxostat 40 mg (WG group; n = 24) or Chinese herbal medicine group, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24)still will receive febuxostat 20 mg + Jiangniaosuan formula and the other group(JNSG; n = 24) will continue to receive Jiangniaosuan formula+Placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in Traditional Chinese Medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.Discussion: We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.Dissemination: The results will be published in a peer-reviewed journal and disseminated by academic conferences.Trial registration : This trial is registered with ClinicalTrials.gov, number ChiCTR2000041083. 22 Registered on 3 May 2021.

A Randomized Controlled Trial of Professional Development for Interdisciplinary Civic Education: Impacts on Humanities Teachers and Their Students

2015 ◽  
Vol 117 (2) ◽  
pp. 1-52
Author(s):  
Dennis J. Barr ◽  
Beth Boulay ◽  
Robert L. Selman ◽  
Rachel Mccormick ◽  
Ethan Lowenstein ◽  
...  
Keyword(s):  
Professional Development ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
The United States ◽  
Performance Measure ◽  
Civic Learning ◽  
Randomized Controlled ◽  
10Th Grade ◽  
The Impact

Background/Context Billions of dollars are spent annually on professional development (PD) for educators, yet few randomized controlled trials (RCT) have demonstrated the ultimate impact PD has on student learning. Further, while policymakers and others speak to the role schools should play in developing students’ civic awareness, RCTs of PD designed to foster civic learning are rare. This randomized controlled trial contributes to the knowledge base on the effectiveness of PD designed to integrate civic learning, ethical reflection, and historical thinking skills into high school humanities courses. Focus of Study The study examined the impact of a PD intervention in two areas: (a) teacher self-efficacy, burnout, and professional engagement and satisfaction; and (b) the academic, civic, social, and ethical competencies of 9th and 10th grade students in the teachers’ classes. Population/Participants/Subjects The study involved 113 teachers and 1,371 9th and 10th grade students in 60 high schools from eight metropolitan regions in the United States. Intervention/Program/Practice The intervention, Facing History and Ourselves, provides PD through a five-day seminar, curricular materials, and follow-up coaching and workshops to help teachers develop their capacities to implement an interdisciplinary historical case study unit using student-centered pedagogy. Research Design The study used a school-level, randomized, experimental design to investigate impacts of the intervention for teachers and their 9th and 10th grade students. Findings/Results Intervention teachers showed significantly greater self-efficacy in all eight assessed domains, more positive perceptions of professional support, satisfaction and growth, and greater personal accomplishment. Intervention students demonstrated stronger skills for analyzing evidence, agency, and cause and effect on a historical understanding performance measure; greater self-reported civic efficacy and tolerance for others with different views; and more positive perceptions of the classroom climate and the opportunities afforded for engaging with civic matters. Fidelity analysis found these causal effects despite the fact that roughly half of the intervention teachers did not fully implement the program. Conclusions/Recommendations Educators need evidence-based approaches for teaching complex social, civic, and political issues enabling students of diverse mindsets and backgrounds to engage constructively with one another while obtaining necessary skills and knowledge. These findings provide empirical support for a professional development approach that engages teachers in fostering academic and civic competencies critical to both participation in a democracy and success in college and career.

EXPRESS: Impact of renal impairment on short-term outcomes following endovascular thrombectomy for acute ischemic stroke: A systematic review and meta-analysis

2021 ◽  
pp. 174749302110473
Author(s):  
Jin Pyeong Jeon ◽  
Chih-Hao Chen ◽  
Fon-Yih Tsuang ◽  
Jianming Liu ◽  
Michael D Hill ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ischemic Stroke ◽  
Renal Impairment ◽  
Acute Ischemic Stroke ◽  
Meta Analysis ◽  
Functional Independence ◽  
Continuous Variable ◽  
Endovascular Thrombectomy ◽  
Symptomatic Intracerebral Hemorrhage ◽  
The Impact

Background. The impact of renal impairment (RI) on the outcomes of patients with acute ischemic stroke (AIS) treated with endovascular thrombectomy (EVT) was relatively limited and contradictory. We performed a systematic review and meta-analysis to investigate this. Aims. We registered a protocol on September 2020 and searched MEDLINE, EMBASE, and Google Scholar accordingly. RI was defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2. Predefined outcomes included functional independence (defined as a modified Rankin Scale of 0, 1, or 2) at 3 months, successful reperfusion, mortality, and symptomatic intracerebral hemorrhage (sICH). Summary of review. Eleven studies involving 3453 patients were included. For the unadjusted outcomes, RI was associated with fewer functional independence (odds ratio (OR), 0.49; 95% confidence interval (CI), 0.39–0.62) and higher mortality (OR, 2.55; 95% CI, 2.03–3.21). RI was not associated with successful reperfusion (OR, 0.80; 95% CI 0.63–1.00) and sICH (OR, 1.41; 95% CI, 0.95–2.10). For the adjusted outcomes, results derived from a multivariate meta-analysis were consistent with the respective unadjusted outcomes: functional independence (OR, 0.59; 95% CI, 0.45–0.77), mortality (OR, 2.23, 95% CI, 1.45–3.43), and sICH (OR, 1.34; 95% CI, 0.85–2.10). Conclusions. We presented the first systematic review to demonstrate that RI is associated with fewer functional independence and higher mortality. Future EVT studies should publish complete renal eGFR data to facilitate prognostic studies and permit eGFR to be analyzed in a continuous variable. Systematic Review Registration: PROSPERO CRD42020191309

Abstract P488: The Impact of First Pass Effect on Acute Ischemic Stroke Clinical Outcomes: Why We Need to Continue to Improve Mechanical Thrombectomy?

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Ameer E Hassan ◽  
Mahmoud Dibas ◽  
Amr Ehab El-Qushayri ◽  
Sherief Ghozy ◽  
Adam A Dmytriw ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Clinical Outcomes ◽  
Mechanical Thrombectomy ◽  
Functional Independence ◽  
Vessel Occlusion ◽  
First Pass Effect ◽  
Improved Outcomes ◽  
First Pass ◽  
The Impact

Background: Mechanical thrombectomy (MT) has significantly improved outcomes of acute ischemic stroke (AIS) patients due to large vessel occlusion (LVO). The first-pass effect (FPE), defined as achieving complete reperfusion (mTICI3/2c) with a single pass, was reported to be associated with higher functional independence rates following EVT and has been emphasized as an important procedural target. We compared MT outcomes in patients who achieved FPE to those who did not in a real world large database. Method: A retrospective analysis of LVO pts who underwent MT from a single center prospectively collected database. Patients were stratified into those who achieved FPE and non-FPE. The primary outcome (discharge and 90 day mRS 0-2) and safety (sICH, mortality and neuro-worsening) were compared between the two groups. Results: Of 580 pts, 261 (45%) achieved FPE and 319 (55%) were non-FPE. Mean age was (70 vs 71, p=0.051) and mean initial NIHSS (16 vs 17, p=0.23) and IV tPA rates (37% bs 36%, p=0.9) were similar between the two groups. Other baseline characteristics were similar. Non-FPE pts required more stenting (15% vs 25%, p=0.003), and angioplasty (19% vs 29%, p=0.01). The FPE group had significantly more instances of discharge (33% vs 17%, p<0.001), and 90-day mRS score 0-2 (29% vs 20%, p<0.001), respectively. Additionally, the FPE group had a significant lower mean discharge NIHSS score (12 vs 17, p<0.001). FPE group had better safety outcomes with lower mortality (14.2% vs 21.6%, p=0.03), sICH (5.7% vs 13.5, p=0.004), and neurological worsening (71.3% vs 78.4%, p=0.02), compared to the non-FPE group. Conclusion: Patients with first pass complete or near complete reperfusion with MT had higher functional independence rates, reduced mortality, symptomatic hemorrhage and neurological worsening. Improvement in MT devices and techniques is vital to increase first pass effect and improve clinical outcomes.

Abstract WP25: The Impact of Body Mass Index on Outcomes of Mechanical Thrombectomy for Acute Ischemic Stroke

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Stephanie Chen ◽  
David McCarthy ◽  
Vasu Saini ◽  
Marie Brunet ◽  
Eric Peterson ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Body Mass ◽  
Linear Correlation ◽  
Mechanical Thrombectomy ◽  
Functional Independence ◽  
Normal Weight ◽  
Vessel Occlusion ◽  
The Impact

Background: Obesity is an established risk factor for acute ischemic stroke (AIS), but its impact on clinical outcomes and mortality after AIS remains controversial. In this study, we evaluate the association of body mass index (BMI) on outcomes after mechanical thrombectomy (MT) for large vessel occlusion acute ischemic stroke (LVOS). Methods: We reviewed our prospective MT database for LVOS between 2015 and 2018. BMI was analyzed as a continuous and categorical variable with underweight BMI <18.5, normal BMI 18.5-24.9, overweight BMI 25-29.9, and obese BMI>30. Multivariate analysis was used to determine predictors of outcome. Results: 335 patients underwent MT with 7 (2.1%) patients classified as underweight, 107 (31.9%) normal, 141 (42.1%) overweight, and 80 (23.9%) obese. Compared to normal weight (reference), obese patients had higher rates of hypertension and hyperlipidemia, while underweight patients had higher rates of previous stroke and presentation NIHSS. The time from symptom onset to puncture, procedural techniques, and reperfusion success (>TICI 2b) was not significantly different between BMI categories. There was a significant inverse linear correlation between BMI and symptomatic hemorrhagic. In patients with successful reperfusion (>TICI 2b), there was also a significant bell-shaped relationship between BMI and functional independence (mRS < 3) with both low and high BMIs associated with worse outcomes. In patients without post-procedural symptomatic hemorrhage, there was a significant linear correlation between BMI and inpatient mortality. Conclusion: In LVOS patients treated with MT, BMI is inversely related with post-procedural symptomatic hemorrhage. Yet in those whom reperfusion is achieved, both lower and higher than normal BMI were associated with worse functional outcomes. Thus, the obesity paradox does not appear to pertain to mechanical thrombectomy, although larger prospective studies are necessary.

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