Baseline Postural Control Measures: An Indicator for Increased Injury Frequency Following Sports Related Concussion

INTRODUCTION: An increase in acute lower extremity (LE) injuries have been observed in athletes following sports-related concussion.1, 2, 3 It has been suggested that lingering postural control deficits as a result of concussive injury, may play a role in the increased prevalence of injury.1 PURPOSE: To investigate the relationship between baseline postural control metrics (Root Mean Square; Peak Excursion Velocity; Sample Entropy) and acute LE injury frequency in NCAA Division I student athletes (SA) with a previous history of concussion. METHODS: Eighty-four NCAA Division I SA were selected from a single university, 42 SA with a previous history of concussion (CONC) and 42 without as the control group (CTRL). Baseline postural control assessment, measured via force platform (Sample frequency 1000Hz), and medical charts were retrospectively reviewed. Postural control assessment consisted of three trials of eyes-open (EO) and eyes-closed (EC) quiet stance for duration of 30 sec. Center of pressure data was used to quantify peak excursion velocity (PEV), root mean square (RMS) and sample entropy (SampEn) in the anterior-posterior (AP) and medial-lateral (ML) direction. Medical records were assessed for all acute LE injuries sustained one-year following baseline postural control assessments. RESULTS: Chi squared analysis revealed a significant increase in frequency (p = 0.025) of acute LE injuries within CONC (22/49 = 44.9%) in comparison to CTRL (10/44 = 22.7%). Paired sample t-test demonstrated a significant decreased in EC PEV AP (p = 0.006) of the CONC group (0.063 ± 0.025) compared to CTRL (0.078 ± 0.038) with moderate effect (Cohen’s d = 0.487), but lacked significance in all other conditions. While the logistic regression model lacked overall significance (p = 0.379), participant group (B = 1.302, P = 0.033) and EO SampEn AP (B = -6.086, P = 0.062) were significant predictors for acute LE injury. CONCLUSION: The results of this study suggest that SA with a previous history of concussion do have a higher acute LE injury frequency than those without a history of concussion. And variations in baseline postural control assessments may help to identify this increase in frequenc

Baseline postural control and lower extremity injury incidence among those with a history of concussion

Context: Lower extremity musculoskeletal (LEMSK) injury may be more prevalent among those with a history of sport-related concussion (SRC). Objective: To investigate the relationship between baseline postural control metrics and the LEMSK injury incidence in National Collegiate Athletic Association Division I student-athletes with a history of SRC. Setting: National Collegiate Athletic Association Division I athletes. Design: Cohort study. Patients or Other Participants: Of 84 total athletes (62 males), 42 had been previously diagnosed with an SRC, and 42 were matched controls based on age, sex, height, weight, and sport. Main Outcome Measure(s): During the preseason baseline evaluation, all participants performed 3 trials of eyes-open and eyes-closed upright quiet stance on a force platform. Medical charts were assessed for all the LEMSK injuries that occurred from preseason baseline to 1 year later. Center-of-pressure data in the anteroposterior and mediolateral directions were filtered before we calculated root mean square and mean excursion velocity; the complexity index was calculated from the unfiltered data. Factorial analysis-of-variance models were used to examine differences between groups and across conditions for root mean square; mean excursion velocity, complexity index, and tests of association to examine between-groups LEMSK differences; and logistic regression models to predict LEMSK. Results: Concussion history and injury incidence were related in the SRC group (P ¼ .043). The complexity index of the SRC group was lower with eyes closed (14.08 6 0.63 versus 15.93 6 0.52) and eyes open (10.25 6 0.52 vs 11.80 6 0.57) in the mediolateral direction than for the control participants (P, .05). Eyes-open root mean square in the mediolateral direction was greater for the SRC group (5.00 6 0.28 mm) than the control group (4.10 6 0.22 mm). Logistic regression models significantly predicted LEMSK only in control participants. Conclusions: These findings may suggest that LEMSK after SRC cannot be predicted from postural-control metrics at baseline

Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

International audienceAbstract Introduction The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. Methods This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. Results From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those < 18 years of age included 549 (12%) aged 1 to 4 years, 750 (16%) 5 to 11 years, and 930 (19%) aged 12–17 years. At baseline, the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein for 1090 participants was 72 (50, 116) EU/mL. Discussion The PREVAC trial is evaluating—placebo-controlled—two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children. Trial registration ClinicalTrials.gov NCT02876328 . Registered on 23 August 2016