scholarly journals The Effects of Continuous vs. Intermittent Prism Adaptation Protocols for Treating Visuospatial Neglect: A Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Jannik Florian Scheffels ◽  
Sona Korabova ◽  
Paul Eling ◽  
Andreas Kastrup ◽  
Helmut Hildebrandt
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Prism Adaptation ◽  
Body Orientation ◽  
Effect Sizes ◽  
Secondary Outcome ◽  
Visuospatial Neglect ◽  
Outcome Parameters ◽  
Randomized Controlled ◽  
Similar Intensity

Visuospatial neglect may interfere with activities of daily living (ADL). Prism adaptation (PA) is one treatment option and may involve two components: recalibration (more strategic) and realignment (more implicit). We examined whether recalibration or realignment is the driving force in neglect rehabilitation using PA. In a randomized controlled trial with two recruitment series and a cross-over design, 24 neglect patients were allocated to a continuous (PA-c) or intermittent (PA-i) PA procedure. During the PA-c condition, goggles were worn without doffing. In the PA-i condition, patients donned goggles twice (first series of patients) or three times (second series) during training to induce more recalibrations. Primary outcome parameters were performance (omissions) on the Apples Cancellation Test and ADL scores. To assess the efficacy of the PA treatment, we compared effect sizes of the current study with those from three groups from previous studies at the same rehabilitation unit: (1) a passive treatment with a similar intensity, (2) a placebo treatment with a similar intensity, and (3) a PA treatment with fewer therapy sessions. Treatment conditions did not significantly predict scores on primary and most secondary outcome parameters. However, the spontaneous ipsilesional body orientation improved only in patients receiving the PA-i condition and this improvement also appeared in patients showing a strong after-effect (irrespective of condition). Effect sizes for the Apples Cancellation Test and the Functional Independence Measure were larger for both PA treatment protocols than the historical control groups. We conclude that more recalibrations during an intermittent PA treatment may have a beneficial effect on spontaneous body orientation but not on other aspects of neglect or on ADL performance.Clinical Trial Registration: German Clinical Trials Register, identifier: DRKS00018813, DRKS00021539.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

scholarly journals OP0010 EFFECTIVENESS OF THE MAKING IT WORK™ PROGRAM AT IMPROVING PRESENTEEISM AND WORK CESSATION IN WORKERS WITH INFLAMMATORY ARTHRITIS – RESULTS OF A RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 7.1-8
Author(s):  
A. Luquini ◽  
Y. Zheng ◽  
H. Xie ◽  
C. Backman ◽  
P. Rogers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Work Disability ◽  
Inflammatory Arthritis ◽  
Missing Values ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Mixed Effect ◽  
Randomized Controlled ◽  
Baseline Characteristics

Background:Arthritis often leads to presenteeism (decreased at-work productivity), missed days from work and permanent work disability, leading to reduced quality of life and high costs to individuals and society. Yet, health services addressing the employment needs of people with arthritis are lacking.Objectives:We evaluated the effectiveness of the Making-it-WorkTM(MiW) program, an online self-management program developed to help people with inflammatory arthritis (IA) deal with employment issues.Methods:A multi-center RCT evaluated the effectiveness of MiW at improving presenteeism and preventing work cessation (WC) over two years. Participants were recruited from rheumatologist practices, consumer organizations and arthritis programs, in three Canadian provinces. Eligibility criteria: diagnosis of IA, employed, age 18-59, and concerned about ability to work. Participants were randomized 1:1 to MiW or usual care plus printed material on workplace tips. MiW consists of five online self-learning modules and group meetings, and individual vocational counselling and ergonomic consultations. Questionnaires were administered every 6 months. Outcomes were presenteeism [Rheumatoid Arthritis Work Instability Scale (RA-WIS)], time to WC ≥ 6 months, and time to WC ≥ 2 months (secondary outcome). Baseline characteristics (age, gender, ethnicity, occupation, education, disease duration and self-employment) were collected. Intention-to-treat (ITT) longitudinal analysis of RA-WIS using linear mixed effect regression models with 2-year comparison as primary endpoint and survival analysis for time to WC using Kaplan-Meier and Cox Proportional Hazard models were performed. Robustness analyses were conducted by using various missing values imputation methods like last observation carried forward, imputation using worse possible outcomes and model-based multiple imputations; using square root transformation of RA-WIS outcome; and adjusting for baseline covariates. SAS version 9.4 was used.Results:A total of 564 participants were recruited, with 478 (84.75%) completing 2-year follow-up. Baseline characteristics were similar between groups. Mean RA-WIS scores were significantly lower in the intervention group from 6 months onwards, with the greatest difference observed at 2 years (-1.78, 95%CI: -2.7, -0.9, p < .0001), yielding a standardized effect size of 32%. Satisfactory robustness was observed. Work cessation occurred less often in intervention than control groups, but only reached statistical significance for WC ≥ 2 months (WC ≥ 6 months: 31 versus 44 events, aHR 0.70, 95%CI: 0.44, 1.11, p = 0.13; WC ≥ 2 months: 39 versus 61 events, aHR: 0.65, 95%CI: 0.43, 0.98, p = 0.04).Conclusion:Results of the RCT reveal the program was effective at improving presenteeism and preventing short-term WC. Effectiveness at preventing long-term work disability will be assessed at 5 years. This program fills one of the most important and costly unmet needs for people with inflammatory arthritis.References:[1]Carruthers EC, Rogers P, Backman CL, et al. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol).BMC Med Inform Decis Mak. 2014;14:59. Published 2014 Jul 21. doi:10.1186/1472-6947-14-59Disclosure of Interests:Andre Luquini: None declared, Yufei Zheng: None declared, Hui Xie: None declared, Catherine Backman: None declared, Pamela Rogers: None declared, Alex Kwok: None declared, Astrid Knight: None declared, Monique Gignac: None declared, Dianne Mosher: None declared, Linda Li: None declared, John Esdaile: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Lacaille: None declared

scholarly journals COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

scholarly journals Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Endoscopic Surgery ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial

scholarly journals A randomized controlled study to compare the efficacy of hughes abdominal repair with conventional abdominal closure-to reduce the incidence of incisional hernias in Indian population

2017 ◽  
Vol 4 (7) ◽  
pp. 2291
Author(s):  
Rajasekaran C. ◽  
Vijaykumar K. ◽  
Arulkumaran M. ◽  
Meera S. S.
Keyword(s):  
Randomized Controlled Trial ◽  
Incisional Hernia ◽  
Abdominal Wall ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Midline Laparotomy ◽  
Incisional Hernias ◽  
Abdominal Closure ◽  
Randomized Controlled ◽  
Abdominal Repair

Background: Incisional hernia forms the most common delayed morbidity following midline laparotomy surgeries- causing mental trauma to the patient impairing their quality of life and scars the name and fame of the surgeon. So, the need for possible attributes on surgeon’s aspect to prevent the incisional hernia is the need of the hour. We planned a randomized controlled trial to compare two different abdominal closure techniques to reduce the incidence of Incisional hernia following midline laparotomy incisions. We advocated Hughes abdominal repair which includes a series of two horizontal and two vertical mattresses within single suture whereby the tension load of suture is distributed both along and across the suture line.Methods: 1:1 Randomized controlled trial in which the patient is blinded and obviously operating surgeon is non-blinded. Evaluating examiner and radiologist are blinded.100 patients who underwent emergency and elective midline laparotomies were enrolled in the study and intra-operatively randomized into two groups in 1:1 pattern. Ethical clearance obtained from the Institutional ethical committee. The primary outcome measure is the incidence of burst abdomen at the end of 15 days by the evaluating surgeon (non-operated surgeon who is blinded). The secondary outcome is the incidence of incisional hernia at the end of one year-evaluated by detailed clinical examination with radiological proof using CT abdomen.Results: The incidence of incisional hernia is significantly low in Hughes abdominal repair than conventional abdominal closure.Conclusions: Hughes abdominal wall closure is superior to conventional closure in both emergency and elective laparotomy cases, in prevention of wound dehiscence and Incisional hernias later. Present study encourages us that Hughes abdominal wall repair is comparable to mesh repairs. This study needs to be continued further to a vast sample size to perfectly assess the statistical significance.

scholarly journals PREWARMING FOR PREVENTION OF PERIOPERATIVE HYPOTHERMIA IN PATIENTS WITH COMBINED EPIDURAL AND GENERAL ANESTHESIA: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
General Anesthesia ◽  
Outcome Measures ◽  
Medical Center ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Perioperative Hypothermia ◽  
Randomized Controlled ◽  
Physical Status Classification ◽  
American Society

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.

Comparative effectiveness of a serious game and usual supervised work for postpartum hemorrhage management: a crossover randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Sandrine Voillequin ◽  
Patrick Rozenberg ◽  
Katell Le Tutour ◽  
Anne Rousseau
Keyword(s):  
Randomized Controlled Trial ◽  
Student Satisfaction ◽  
Postpartum Hemorrhage ◽  
Controlled Trial ◽  
Ease Of Use ◽  
Serious Game ◽  
Case Vignette ◽  
Secondary Outcome ◽  
Decision Algorithm ◽  
Randomized Controlled

UNSTRUCTURED Purpose: Because serious games promote learning and cognitive skill development, they may be useful for teaching students to manage postpartum hemorrhage (PPH) and its complex decision algorithm. This study aimed to compare the effectiveness of a serious game with usual supervised work in producing knowledge and satisfaction. Methods: This two-center two-stage crossover randomized controlled trial included student midwives. One group underwent the serious game intervention in the first period (January 2018) and the usual supervised classroom work in the second (May 2018); the other group followed the reverse chronology. The primary outcome was knowledge of the PPH management algorithm, assessed by responses to a case vignette after each intervention session. Satisfaction was the secondary outcome. Results: The serious game-supervised work (SG-SW) chronology was allocated to 48 students, and its inverse (SW-SG) to 47; knowledge did not differ between the two groups (respectively, 89.5% versus 83.5%, P=0.3). Satisfaction was significantly higher for the game for its overall grade (6.8 vs 6.1, P=0.009), engagingness (very good 82.1% vs 24.3%, P<.001), and ease of use (very good 77.9% vs 46.1%, P<.001) Conclusion: The serious game did not produce more knowledge than supervised work, but is probably educationally useful because of greater student satisfaction.

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