Enhanced early sensory outcome after nerve repair as a result of immediate post-operative re-learning: a randomized controlled trial

2014 ◽  
Vol 40 (6) ◽  
pp. 598-606 ◽  
Author(s):  
B. Rosén ◽  
P. Vikström ◽  
S. Turner ◽  
D. A. McGrouther ◽  
R. W. Selles ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Nerve Repair ◽  
Intervention Group ◽  
Control Group ◽  
Level Of Evidence ◽  
Test Part ◽  
Randomized Controlled ◽  
Identification Test

We assessed the use of guided plasticity training to improve the outcome in the first 6 months after nerve repair. In a multicentre randomized controlled trial, 37 adults with median or ulnar nerve repair at the distal forearm were randomized to intervention, starting the first week after surgery with sensory and motor re-learning using mirror visual feedback and observation of touch, or to a control group with re-learning starting when reinnervation could be detected. The primary outcome at 3 and 6 months post-operatively was discriminative touch (shape texture identification test, part of the Rosen score). At 6 months, discriminative touch was significantly better in the early intervention group. Improvement of discriminative touch between 3 and 6 months was also significantly greater in that group. There were no significant differences in motor function, pain or in the total score. We conclude that early re-learning using guided plasticity may have a potential to improve the outcomes after nerve repair. Level of evidence: II

scholarly journals An Injury Prevention Program for Professional Ballet: A Randomized Controlled Investigation

2020 ◽  
Vol 8 (7) ◽  
pp. 232596712093764
Author(s):  
Angelina M. Vera ◽  
Bene D. Barrera ◽  
Leif E. Peterson ◽  
Thomas R. Yetter ◽  
David Dong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Injury Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Injury Rate ◽  
Hazard Ratio ◽  
Control Group ◽  
Level Of Evidence ◽  
Entire Study ◽  
Randomized Controlled

Background: Few investigations have examined dance-specific injury prevention programs (IPPs), and no published randomized controlled trials are available that evaluate IPPs for dance. Hypothesis: The implementation of an IPP will significantly reduce the risk of injury in professional ballet dancers. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A randomized controlled trial was designed that entailed a superiority model for the intervention group. All professional dancers from a single ballet company were eligible to participate. Randomization and allocation were performed before the start of the season. The control group practiced and performed without change to preexisting standard operating practice. The IPP group was instructed to perform a 30-minute exercise program 3 times per week over the 52-week study period. Injuries were recorded. Standard continuous and categorical data comparisons and correlations were used. Cox proportional hazards regression models for recurrent failures were used wherein the hazard ratio indicates the relative likelihood of injury in the control versus intervention groups. Results: Of the 52 eligible dancers, 75% (n = 39) participated. Of these 39 dancers, 19 (9 males, 10 females; mean age, 26.6 ± 4.0 years) were randomized to the control group and 20 (11 males, 9 females; mean age, 25.1 ± 5.1 years) to the IPP group. No significant ( P > .05) difference was found in baseline demographics between groups. A total of 116 injuries were recorded for the entire study population (49 IPP; 67 control). Traumatic and chronic injuries accounted for 54% and 46% of injuries, respectively. The injury rate was 82% less (IPP hazard ratio, 0.18; z = –2.29; P = .022) in the IPP group after adjustment for confounding variables, and time between injuries was 45% longer (IPP hazard ratio, 0.55; z = –2.20; P = .028) than for controls. Conclusion: The present study is the first prospective randomized controlled investigation of an IPP for professional ballet. The results showed an 82% decrease in injury rate for the intervention group and an extended period from previous injury to subsequent injury. Registration: NCT04110002 ( ClinicalTrials.gov identifier ).

Foot Core Training to Prevent Running-Related Injuries: A Survival Analysis of a Single-Blind, Randomized Controlled Trial

2020 ◽  
Vol 48 (14) ◽  
pp. 3610-3619
Author(s):  
Ulisses T. Taddei ◽  
Alessandra B. Matias ◽  
Marcos Duarte ◽  
Isabel C.N. Sacco
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Injury Incidence ◽  
Long Distance ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Foot Posture ◽  
Recreational Runners

Background: Running-related injuries (RRIs) are a pervasive menace that can interrupt or end the participation of recreational runners in this healthy physical activity. To date, no satisfactory treatment has been developed to prevent RRIs. Purpose: To investigate the efficacy of a novel foot core strengthening protocol based on a ground-up approach to reduce the incidence of RRIs in recreational long-distance runners over the course of a 1-year follow-up. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The participants, 118 runners, were assessed at baseline and randomly allocated to either an intervention group (n = 57) or a control group (n = 61). The intervention group received an 8-week training course focused on the foot-ankle muscles, followed by remotely supervised training thereafter. Assessments consisted of 3 separate biomechanical evaluations of foot strength and foot posture and a weekly report on each participant’s running distance, pace, and injury incidence over 12 months. Results: The control group participants were 2.42 times (95% CI, 1.98-3.62) more likely to experience an RRI within the 12-month study period than participants in the intervention group ( P = .035). Time to injury was significantly correlated with Foot Posture Index ( P = .031; r = 0.41) and foot strength gain ( P = .044; r = 0.45) scores. This foot exercise program showed evidence of effective RRI risk reduction in recreational runners at 4 to 8 months of training. Conclusion: Recreational runners randomized to the new foot core strengthening protocol had a 2.42-fold lower rate of RRIs compared with the control group. Further studies are recommended to better understand the underlying biomechanical mechanisms of injury, types of injuries, and subgroups of runners who might benefit maximally. Registration: NCT02306148 (ClinicalTrials.gov identifier).

scholarly journals Mobilization in the evening reduces delirium in critically ill patients: the MENTAL randomized, controlled trial

2019 ◽  
Author(s):  
Peter Nydahl ◽  
David McWilliams ◽  
Norbert Weiler ◽  
Christoph Borzikowsky ◽  
Fiona Howroyd ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Early Mobilization ◽  
Control Group ◽  
Number Needed To Treat ◽  
Randomized Controlled ◽  
Post Hoc

Abstract Background : Delirium is a common complication in patients on Intensive Care Units (ICU). Caring interventions such as early mobilization are effective in prevention and treatment of delirium, but are recommended during daytime. It may be effective in the night, too. Method : The aim of this study was to prove the effect of mobilization in the evening to prevent or treat ICU patients from delirium. The design was a multicentric, randomized, controlled trial in 5 mixed ICUs over a period of 2 weeks with max. 28 days follow-up. Patients in the intervention group were mobilized onto the edge of the bed or more between 9:00 and 11:00 p.m. by an additional mobilization team, following safety criteria. Patients in the control group received usual care. Primary outcome parameter was the duration of a delirium. Secondary parameters were presence of delirium, mortality, duration of mechanical ventilation (MV) and stay, feasibility, and mobilization-related complications. Results : In summary, n=69 patients could be analysed (intervention n=36, control n=33). Due to limited resources, the trial was stopped and reached 62% of targeted sample size. Mobilization in the evening did not significantly reduce duration of existing delirium, delirium presence, length of MV or days in ICU and hospital for 28 days follow-up. In an unplanned post-hoc analysis, mobilization in the evening prevented patients from delirium in the first four days (6 (16.7%) vs. 13 (39.4%), p=0.032), with a number needed to treat of 5. The intervention was feasible in 71.7% of eligible patients, with 13.6% unwanted safety events. Conclusions : In a mixed ICU population, mobilization in the evening did not show a reduction in duration of delirium, MV or length of stay, but a reduction in the incidence of early onset delirium. Mobilization between 9:00 and 11:00 pm. by an interprofessional mobilization team may prevent patients from delirium. The intervention was feasible, safe, and accepted by most patients.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Group Data ◽  
Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

scholarly journals Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mariko Nishikawa ◽  
Masaaki Yamanaka ◽  
Akira Shibanuma ◽  
Junko Kiriya ◽  
Masamine Jimba
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Safety Information ◽  
Intervention Group ◽  
Health And Safety ◽  
Trial Registration ◽  
Control Group ◽  
Internet Portal ◽  
Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

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