scholarly journals Early Mobilization in Ischemic Stroke: A Pilot Randomized Trial of Safety and Feasibility in a Public Hospital in Brazil

2015 ◽  
Vol 5 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Simone Rosa Poletto ◽  
Letícia Costa Rebello ◽  
Maria Júlia Monteiro Valença ◽  
Daniele Rossato ◽  
Andrea Garcia Almeida ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Public Hospital ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Intervention Group ◽  
Total Duration ◽  
Early Mobilization ◽  
Functional Independence ◽  
Control Group

Background: The effect of early mobilization after acute stroke is still unclear, although some studies have suggested improvement in outcomes. We conducted a randomized, single-blind, controlled trial seeking to evaluate the feasibility, safety, and benefit of early mobilization for patients with acute ischemic stroke treated in a public teaching hospital in Southern Brazil. This report presents the feasibility and safety findings for the pilot phase of this trial. Methods: The primary outcomes were time to first mobilization, total duration of mobilization, complications during early mobilization, falls within 3 months, mortality within 3 months, and medical complications of immobility. We included adult patients with CT- or MRI-confirmed ischemic stroke within 48 h of symptom onset who were admitted from March to November 2012 to the acute vascular unit or general emergency unit of a large urban emergency department (ED) at the Hospital de Clínicas de Porto Alegre. The severity of the neurological deficit on admission was assessed by the National Institutes of Health Stroke Scale (NIHSS). The NIHSS and modified Rankin Scale (mRS, functional outcome) scores were assessed on day 14 or at discharge as well as at 3 months. Activities of daily living (ADL) were measured with the modified Barthel Index (mBI) at 3 months. Results: Thirty-seven patients (mean age 65 years, mean NIHSS score 11) were randomly allocated to an intervention group (IG) or a control group (CG). The IG received earlier (p = 0.001) and more frequent (p < 0.0001) mobilization than the CG. Of the 19 patients in the CG, only 5 (26%) underwent a physical therapy program during hospitalization. No complications (symptomatic hypotension or worsening of neurological symptoms) were observed in association with early mobilization. The rates of complications of immobility (pneumonia, pulmonary embolism, and deep vein thrombosis) and mortality were similar in the two groups. No statistically significant differences in functional independence, disability, or ADL (mBI ≥85) were observed between the groups at the 3-month follow-up. Conclusions: This pilot trial conducted at a public hospital in Brazil suggests that early mobilization after acute ischemic stroke is safe and feasible. Despite some challenges and limitations, early mobilization was successfully implemented, even in the setting of a large, complex ED, and without complications. Patients from the IG were mobilized much earlier than controls receiving the standard care provided in most Brazilian hospitals.

Economic Evaluation of Endovascular Treatment for Acute Ischemic Stroke

Stroke ◽  
2021 ◽  
Author(s):  
Lucie A. van den Berg ◽  
Olvert A. Berkhemer ◽  
Puck S.S. Fransen ◽  
Debbie Beumer ◽  
Hester Lingsma ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Usual Care ◽  
Acute Ischemic Stroke ◽  
Intervention Group ◽  
Functional Independence ◽  
Quality Adjusted Life Year ◽  
Control Group ◽  
Unique Identifier ◽  
Quality Adjusted Life

Background and Purpose: Endovascular treatment for acute ischemic stroke has been proven clinically effective, but evidence of the cost-effectiveness based on real-world data is scarce. The aim of this study was to assess whether endovascular therapy plus usual care is cost-effective in comparison to usual care alone in acute ischemic stroke patients. Methods: An economic evaluation was performed from a societal perspective with a 2-year time horizon. Empirical data on health outcomes and the use of resources following endovascular treatment were gathered parallel to the MR CLEAN trial (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) and its 2-year follow-up study. Incremental cost-effectiveness ratios were calculated as the extra costs per additional patient with functional independence (modified Rankin Scale score 0–2) and the extra cost per quality-adjusted life year gained. Results: The mean costs per patient in the intervention group were $126 494 versus $143 331 in the control group (mean difference, −$16 839 [95% CI, −$38 113 to $5456]). Compared with patients in the control group, more patients in the intervention group achieved functional independence, 37.2% versus 23.9% (absolute difference, 13.3% [95% CI, 4.0%–22.0%]) and they generated more quality-adjusted life years, 0.99 versus 0.83 (mean difference of 0.16 [95% CI, 0.04–0.29]). Endovascular treatment dominated standard treatment with $18 233 saved per extra patient with a good outcome and $105 869 saved per additional quality-adjusted life year. Conclusions: Endovascular treatment added to usual care is clinically effective, and cost saving in comparison to usual care alone in patients with acute ischemic stroke. REGISTRATION: URL: https://www.trialregister.nl/trial/695 ; Unique identifier: NL695. https://www.isrctn.com/ISRCTN10888758 ; Unique identifier: ISRCTN10888758.

The effect of practicing yoga during pregnancy on labor stages length, anxiety and pain: a randomized controlled trial

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Ellahe Mohyadin ◽  
Zohreh Ghorashi ◽  
Zahra Molamomanaei
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Total Duration ◽  
Measurement Data ◽  
Labor Pain ◽  
Control Group ◽  
Chi Square ◽  
Nulliparous Women ◽  
Two Stages ◽  
And Control

AbstractBackgroundAnxiety and fear of labor pain has led to elevated cesarean section rate in some countries. This study was conducted to investigate the effect of yoga in pregnancy on anxiety, labor pain and length of labor stages.MethodsThis clinical trial study was performed on 84 nulliparous women who were at least 18 years old and were randomly divided into two groups of yoga and control groups. Pregnancy Yoga Program consisting of 6 60-min training sessions was started every 2 weeks from week 26 of pregnancy and continued until 37 weeks of gestation. Anxiety severity at maternal admission to labor was measured by the Spielbergers State-Trait Anxiety Inventory, and labor pain was measured by Visual Analogue Scale (VAS) at dilatation (4–5 cm) and 2 h after the first measurement. Data were analyzed using Chi-Square and t-test.ResultsIntervention group reported less pain at dilatation (4–5 cm) (p=0.001) and 2 h after the first measurement (p=0.001) than the control group. Stat anxiety was also lower in intervention group than the control group (p=0.003) at the entrance to labor room. Subjects in the control group required more induction compared to intervention group (p=0.003). Women in intervention group experienced shorter duration of the first phase of the labor than the control group (p=0.002). Also, the total duration of two stages of labor was shorter in intervention group than the control group (p=0.003).ConclusionsPracticing yoga during pregnancy may reduce women’s anxiety during labor; shorten labor stages, and lower labor pain.

scholarly journals Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Jun Ni ◽  
Huisheng Chen ◽  
Guofang Chen ◽  
Yong Ji ◽  
Fei Yi ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Thrombolytic Therapy ◽  
Acute Ischemic Stroke ◽  
Barthel Index ◽  
Controlled Trial ◽  
Survival Rates ◽  
Control Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Double Blind

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

Abstract WP419: Secondary Prevention Of Cardiovascular Events With Lifestyle Intervention In Patients With Mild Ischemic Stroke - A Randomized Controlled Trial -

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Sumio Yamada ◽  
Yuji Kono ◽  
Kotaro Iwatsu ◽  
Hisako Okumura ◽  
Junko Yamaguchi ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Lifestyle Intervention ◽  
Lifestyle Modification ◽  
Controlled Trial ◽  
Intervention Group ◽  
Stroke Recurrence ◽  
Control Group ◽  
Vascular Events ◽  
Randomized Controlled ◽  
New Onset

Introduction: Lifestyle modification is associated with a substantially decreased risk of cardiovascular events. However, the role of lifestyle intervention for the secondary prevention in patients with ischemic stroke (IS) is inadequately defined. We assessed the hypothesis that lifestyle intervention which comprised exercise, salt reduction and nutrition advice could reduce new onset of vascular events in patients with mild IS. Methods: We conducted a single-blind randomized controlled trial that enrolled 66 patients (45 men, 21 women; mean age, 63.5 yo) with acute mild ischemic stroke. The patients were randomly allocated to a lifestyle intervention group (n = 33) or control group (n = 33). We performed lifestyle interventions, which comprised exercise training, salt restriction and nutrition advice for 24 weeks. The primary endpoint was ospitalization due to stroke recurrence and new onset of coronary heart disease. We also evaluated blood pressure, serum lipid profile and hemoglobin A1c to compare the efficacy of the lifestyle modification intervention. Results: This trial was terminated earlier than expected because the prespecified early stopping rule for efficacy had been met. After 24 weeks intervention period, the intervention group showed a significant decrease in the clinic and home blood pressure and significant increase in the high density lipoprotein cholesterol (HDL-C) levels from the baseline to the 6-month assessment (clinic and home SBP, P <0.001; HDL-C, P =0.018), with significant differences between the randomized groups (clinic and home SBP, P <0.001; HDL-C, P =0.022). Median duration of follow-up was 2.9 years, 12 patients allocated the control group and 1 patient allocated the lifestyle intervention group had at least one major vascular event. A sequential plans analysis indicated that lifestyle intervention superior to control in interim analysis. Kaplan-Meier survival curves after log-rank test showed significant prognostic difference between randomized groups ( P =0.005). Conclusions: In conclusion, the results of this study indicate that lifestyle intervention is beneficial for preventing stroke recurrence and other vascular events.

scholarly journals Sauna Yoga Superiorly Improves Flexibility, Strength, and Balance: A Two-Armed Randomized Controlled Trial in Healthy Older Adults

2019 ◽  
Vol 16 (19) ◽  
pp. 3721 ◽  
Author(s):  
Bucht ◽  
Donath
Keyword(s):  
Large Scale ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Intervention Group ◽  
Control Group ◽  
Minimization Method ◽  
Important Indicator ◽  
Randomized Controlled ◽  
Eyes Closed ◽  
Healthy Elderly

Besides strength and balance, flexibility is an important indicator of health-related physical fitness. Thus, the aim of this two-armed randomized controlled pilot trial was to investigate whether sauna yoga at a moderate temperature (50 °C) beneficially affects flexibility, strength, balance, and quality of life (QOL) in healthy elderly community dwellers. Participants were randomly assigned to an intervention group (INT, n = 11, age: 68.7 ± 5.9) or control group (CON, n = 12, age: 69.3 ± 4.9), using the minimization method. Age, physical activity, gender, and the primary outcome flexibility were used as strata for group allocation. Both groups completed similar exercises in the sauna over eight weeks. Only the INT group was exposed to moderate temperatures of 50 °C. Large and statistically significant improvement in favor of the sauna group (INT) was observed for the chair sit-and-reach test (INT: +83%, CON +3%, p = 0.028, nр² = 0.24). The shoulder and lateral spine flexibility were not relevantly affected. Strength in the lower extremities merely showed a tendency to significant changes (INT: 16%, CON: 3%, p = 0.061, nр² = 0.181). Additionally, balance abilities, with eyes closed, improved (INT: 187%, CON +58%, p = 0.056, nр² = 0.189) in favor of the INT group. QOL only improved in favor of the INT for environmental dimension (INT: +7%, CON: 0%, p = 0.034, nр² = 0.227). These first but preliminary findings indicate that sauna yoga may serve as a promising and feasible means to improve flexibility in elderly people. Strength and balance do not meaningfully benefit from a sauna environment, although strength improved to a slightly higher extent in the sauna group. Future large-scale research is needed to elucidate underlying mechanisms and corroborate these findings

scholarly journals Effect of Huoxiang Zhengqi Pill on Early Neurological Deterioration in Patients with Acute Ischemic Stroke Undergoing Recanalization Therapy and Predictive Effect of Essen Score

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Zhi-Xin Huang ◽  
Jianguo Lin ◽  
Cheng Zhang ◽  
Ying-Yi Dai ◽  
Songbin Lin ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Primary Outcome ◽  
Univariate Analysis ◽  
Intervention Group ◽  
Clinical Event ◽  
Control Group ◽  
Early Neurological Deterioration ◽  
Treatment Measures ◽  
Risk Patients

Early neurologic deterioration (END) in the acute phase of ischemic stroke is a serious clinical event, which is closely related to poor prognosis. Therefore, it is important to identify presentation features that predict END and take relevant treatment measures, as they could help to prevent the deterioration of high-risk patients. The prospective intervention study was carried out from January 2018 to December 2019. We included consecutive patients hospitalized for acute ischemic stroke (AIS) within 6 hours of onset. Patients were randomly assigned (1 : 1) to recanalization therapy plus Huoxiang Zhengqi Pill (HXZQ) (intervention group) or standard recanalization therapy alone (control group). The primary outcome was the development of END according to predefined criteria within the first 1 week of stroke onset. Poisson regression was used to identify predictors for END. Of the 155 patients enrolled in the study (age, 63 ± 11 years; 28.4% female), 20 (12.9%) developed END. Univariate analysis showed that the use of HXZQ and Essen stroke risk score (ESRS) (low risk group) were protective factors for END, while advanced age was a risk factor for END. However, in multivariate analysis, only ESRS (OR, 0.232; 95%CI, 0.058–0.928; P=0.039) and the use of HXZQ (OR, 0.297; 95%CI, 0.096–0.917; P=0.035) were statistically significant. ESRS can be used as the prediction factor of END. HXZQ has small side effects and wide indication. It could be used in the treatment of AIS.

Efficacy of Integrated Rehabilitation Techniques of Traditional Chinese Medicine for Ischemic Stroke: A Randomized Controlled Trial

2013 ◽  
Vol 41 (05) ◽  
pp. 971-981 ◽  
Author(s):  
Yong Zhang ◽  
He Jin ◽  
Dayong Ma ◽  
Yuanbo Fu ◽  
Yanming Xie ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Alternative Therapy ◽  
Intervention Group ◽  
Lower Limbs ◽  
Control Group ◽  
Significant Difference ◽  
Long Term Observation

This study aimed to determine the efficacy of Integrated Rehabilitation Techniques of Traditional Chinese Medicine (IRT-TCM) on patients with ischemic stroke as an alternative therapy to conventional rehabilitation techniques. Sixty-nine patients with ischemic stroke were randomly assigned to receive either IRT-TCM (intervention group, n = 46) or conventional rehabilitation techniques (control group, n = 23). The IRT-TCM consisted of a sequential combination of acupuncture and massage techniques. The Fugl-Meyer Assessment (FMA), National Institutes of Health Stroke Scale (NIHSS), Barthel index (BI) and modified Rankin Scale (mRS) were measured on day 0 (baseline, before treatment), day 21, and day 90. We observed that the scores in FMA and BI were increased, and NIHSS were decreased in both groups on day 21 and 90, compared with the baseline (day 0). Furthermore, significantly better scores in FMA of lower limbs and NIHSS were found in patients treated with IRT-TCM on day 21 and 90. For mRS, the percentage of patients ranking 0 and 1 in the intervention group presented a striking contrast to the control group on day 90 but with no significant difference. The results indicated that, as a feasible alternative therapy, IRT-TCM is beneficial for patients with ischemic stroke. Further research with larger sample size, long-term observation, and strict blinding are still in need to confirm the efficacy of IRT-TCM.

scholarly journals Effectiveness of home rehabilitation for ischemic stroke

2009 ◽  
Vol 1 (1) ◽  
pp. 36 ◽  
Author(s):  
Pakaratee Chaiyawat ◽  
Kongkiat Kulkantrakorn ◽  
Paskorn Sritipsukho
Keyword(s):  
Ischemic Stroke ◽  
Controlled Trial ◽  
Intervention Group ◽  
Stroke Care ◽  
Rehabilitation Program ◽  
Outcome Data ◽  
Depression Score ◽  
Control Group ◽  
Acute Stroke Care ◽  
Middle Cerebral Artery Infarction

The objective of this study was to develop and examine the effectiveness of an individual home rehabilitation program for patients with ischemic stroke. This was a randomized controlled trial in 60 patients with recent middle cerebral artery infarction. After hospital discharge for acute stroke care, they were randomly assigned to receive either a home rehabilitation program for three months (intervention group) or usual care (control group). We collected outcome data over three months after their discharge from the hospital. The Barthel Index (BI), the Modified Rankin Scale (MRS), the health-related quality-of-life index (EQ-5D), the Hospital Anxiety and Depression score (HADs), and the Thai Mental State Examination (TMSE) were used to analyze the outcomes. In the intervention group, all outcomes were significantly better (p

Endovascular Treatment of Ischemic Stroke: An Updated Meta-Analysis of Efficacy and Safety

2017 ◽  
Vol 51 (4) ◽  
pp. 215-219 ◽  
Author(s):  
Simone Vidale ◽  
Elio Agostoni
Keyword(s):  
Ischemic Stroke ◽  
Medical Treatment ◽  
Acute Ischemic Stroke ◽  
Mechanical Thrombectomy ◽  
Meta Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Clinical Effects ◽  
Anterior Circulation ◽  
Best Medical Treatment

Background: Recent randomized trials demonstrated the superiority of the mechanical thrombectomy over the best medical treatment in patients with acute ischemic stroke due to an occlusion of arteries of proximal anterior circulation. In this updated meta-analysis, we aimed to summarize the total clinical effects of the treatment, including the last trials. Methods: We performed literature search of Randomized Crontrolled Trials (RCTs) published between 2010 and October 2016, comparing endovenous thrombolysis plus mechanical thrombectomy (intervention group) with best medical care alone (control group). We identified 8 trials. Primary outcomes were reduced disability at 90 days from the event and symptomatic intracranial hemorrhage. Statistical analysis was performed pooling data into the 2 groups, evaluating outcome heterogeneity. The Mantel-Haenszel method was used to calculate odds ratios (ORs). Results: We analyzed data for 1845 patients (interventional group: 911; control group: 934). Mechanical thrombectomy contributed to a significant reduction in disability rate compared to the best medical treatment alone (OR: 2.087; 95% confidence interval [CI]: 1.718-2.535; P < .001). We calculated that for every 100 treated patients, 16 more participants have a good outcome as a result of mechanical treatment. No significant differences between groups were observed concerning the occurrence of symptomatic hemorrhage (OR: 1.021; 95% CI: 0.641-1.629; P = .739). Conclusion: Mechanical thrombectomy contributes to significantly increase the functional benefit of endovenous thrombolysis in patients with acute ischemic stroke caused by arterial occlusion of proximal anterior circulation, without reduction in safety. These findings are relevant for the optimization of the acute stroke management, including the implementation of networks between stroke centers.

No evidence of effectiveness of mirror therapy early after stroke: an assessor-blinded randomized controlled trial

2019 ◽  
Vol 33 (5) ◽  
pp. 885-893 ◽  
Author(s):  
Paola Antoniotti ◽  
Laura Veronelli ◽  
Antonio Caronni ◽  
Alessia Monti ◽  
Evdoxia Aristidou ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Upper Limb ◽  
Controlled Trial ◽  
Intervention Group ◽  
Functional Independence ◽  
Control Group ◽  
Mirror Therapy ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Flexion Extension

Objective: The aim of this study was to investigate the efficacy of mirror therapy on upper-limb recovery in early post-stroke patients. Design: Assessor-blinded randomized controlled trial. Setting: Inpatient rehabilitation clinic. Subjects: A total of 40 patients with upper-limb impairment due to a first-ever ischaemic or haemorrhagic stroke, within four weeks from the cerebrovascular accident. Intervention: The intervention group received mirror therapy, while the control group received sham therapy. During mirror therapy, patients’ sound hand was reflected by a mirror. During sham therapy, an opaque surface replaced the mirror-reflecting surface. Both the mirror therapy and sham therapy groups practised their sound hand with exercises, ranging from the simple elbow flexion–extension to complex tasks (e.g. reaching and grasping). Mirror therapy and sham therapy were added to conventional rehabilitation. Main measures: Primary outcome includes Fugl–Meyer upper extremity scale. Secondary outcomes include action research arm test (ARAT) and functional independence measure (FIM) scale. Outcomes were measured at the beginning (T0) and end (T1) of the treatment. Results: At baseline, both groups (sham therapy vs. mirror therapy; mean (SD)) were comparable for Fugl–Meyer (30.9 (23.9) vs. 28.5 (21.8)), ARAT (25.1 (25.5) vs. 23.5 (24)) and FIM (71.0 (20.6) vs. 72.9 (17.8)) scores. At the end of the treatment, both groups significantly improved in the Fugl–Meyer (40.6 (21.3) vs. 38.3 (23.4)), ARAT (31.9 (23.0) vs. 30 (24.1)) and FIM (100.3 (21.9) vs. 99.4 (22.6)) scores. However, at T1, no significant difference was observed between the sham therapy and mirror therapy groups, neither for the Fugl–Meyer, nor for ARAT and FIM scores. Conclusion: Compared with sham therapy, mirror therapy did not add additional benefit to upper-limb recovery early after stroke.

Sign in / Sign up

Export Citation Format

Share Document