Is early activity resumption after paediatric concussion safe and does it reduce symptom burden at 2 weeks post injury? The Pediatric Concussion Assessment of Rest and Exertion (PedCARE) multicentre randomised clinical trial

2021 ◽  
pp. bjsports-2021-105030
Author(s):  
Andrée-Anne Ledoux ◽  
Nick Barrowman ◽  
Vid Bijelić ◽  
Michael M Borghese ◽  
Adrienne Davis ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Real Life ◽  
Symptom Burden ◽  
Randomised Clinical Trial ◽  
Mean Difference ◽  
Control Group ◽  
Primary Care Visit ◽  
Post Injury ◽  
Level Of Evidence ◽  
Pediatric Concussion

ObjectiveInvestigate whether resuming physical activity (PA) at 72 hours post concussion is safe and reduces symptoms at 2 weeks, compared with resting until asymptomatic.MethodsReal-life conditions, multicentre, single-blinded randomised clinical trial, conducted in three Canadian paediatric emergency departments (ED). Children/youth aged 10–<18 years with acute concussion were recruited between March 2017 and December 2019, and randomly assigned to a 4-week stepwise return-to-PA protocol at 72 hours post concussion even if symptomatic (experimental group (EG)) or to a return-to-PA once asymptomatic protocol (control group (CG)). The primary outcome was self-reported symptoms at 2 weeks using the Health and Behaviour Inventory. Adherence was measured using accelerometers worn 24 hours/day for 14 days post injury. Adverse events (AE) (worsening of symptoms requiring unscheduled ED or primary care visit) were monitored. Multivariable intention-to-treat (ITT) and per-protocol analyses adjusting for prognostically important covariates were examined. Missing data were imputed for the ITT analysis.Results456 randomised participants (EG: N=227; mean (SD) age=13.3 (2.1) years; 44.5% women; CG: N=229; mean (SD) age=13.3 (2.2) years; 43.7% women) were analysed. No AE were identified. ITT analysis showed no strong evidence of a group difference at 2 weeks (adjusted mean difference=−1.3 (95% CI:−3.6 to 1.1)). In adherent participants, initiating PA 72 hours post injury significantly reduced symptoms 2 weeks post injury, compared with rest (adjusted mean difference=−4.3 (95% CI:−8.4 to –0.2)).ConclusionSymptoms at 2 weeks did not differ significantly between children/youth randomised to initiate PA 72 hours post injury versus resting until asymptomatic; however, many were non-adherent to the intervention. Among adherent participants, early PA was associated with reduced symptoms at 2 weeks. Resumption of PA is safe and may be associated with milder symptoms at 2 weeks.Level of evidence1b.Trial registration numberNCT02893969.Registry namePediatric Concussion Assessment of Rest and Exertion (PedCARE).

scholarly journals Effect of rehabilitation training on an elderly population with mild to moderate hearing loss: study protocol for a randomised clinical trial

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 582
Author(s):  
Parisa Rasouli Fard ◽  
Farnoush Jarollahi ◽  
Seyyed Jalal Sameni ◽  
Mohammad Kamali
Keyword(s):  
Clinical Trial ◽  
Hearing Loss ◽  
Negative Impact ◽  
Intervention Group ◽  
Randomised Clinical Trial ◽  
Control Group ◽  
Rehabilitation Training ◽  
Speech In Noise ◽  
Age Related ◽  
Moderate Hearing Loss

Background: Age-related hearing loss (presbycusis) is a form of hearing loss in over 60-year-olds and has a negative impact on quality of life. The pathophysiology of presbycusis is multifactorial and is predominately characterised with a loss of speech perception in noise. In the cochlea, auditory filters decompose broadband sound into a series of narrowband output signals, which contains two kinds of temporal information: slow changes in overall amplitude envelope (ENV) and faster variations in temporal fine structure (TFS). TFS is important for recognition of target speech in noise. The main aim of the study is to evaluate the effect of TFS rehabilitation training in participants over the age of 60 years with mild to moderate hearing loss. Methods: A randomised clinical trial  conduct on 30 participants with mild (loss of 20-39dB) to moderate (40-69dB) hearing loss, aged between 60 and 75 years old. Participants with conductive hearing loss, abnormal middle ear pathology and central nerve system disease were excluded. Participants were randomly selected to an intervention and control group with a 1:1 ratio. Rehabilitation for the intervention Group are 30-minute sessions three times a week for a total five weeks of vowel consonant vowel words that are used to eliminate ENV and keep only TFS. Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores are performed at the beginning and end of study to evaluate the effect of rehabilitation training. Conclusion:  Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis. A literature review highlighted that TFS damage is permanent; however, in this study we will attempt to prove that TFS training may lead to speech in noise perception restored. Trial registration: Registry of Clinical Trials, IRCT2019625044006N1 (7th August 2019).

Impact of spectacles wear on uncorrected visual acuity among urban migrant primary school children in China: a cluster-randomised clinical trial

2020 ◽  
pp. bjophthalmol-2020-316213
Author(s):  
Xinwu Zhang ◽  
Ming Zhou ◽  
Xiaochen Ma ◽  
Hongmei Yi ◽  
Haiqing Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
School Children ◽  
Randomised Clinical Trial ◽  
Primary School Children ◽  
Control Group ◽  
Cluster Randomised ◽  
Uncorrected Visual Acuity ◽  
Chinese School ◽  
Urban Migrant

ObjectiveTo estimate the effect of providing free spectacles on uncorrected visual acuity (VA) among urban migrant Chinese school children.DesignExploratory analysis from a parallel cluster-randomised clinical trial.MethodsAfter baseline survey and VA screening, eligible children were randomised by school to receive one of the two interventions: free glasses and a teacher incentive (tablet computer if ≥80% of children given glasses were wearing them on un-announced examination) (treatment group) or glasses prescription and letter to parents (control group). The primary outcome was uncorrected logarithm of the minimal angle of resolution (LogMAR) VA at study closeout, adjusted for baseline uncorrected VA.ResultsAmong 4376 randomly selected children, 728 (16.6%, mean age 10.9 years, 51.0% boys) at 94 schools failed VA screening and met eligibility criteria. Of these, 358 children (49.2%) at 47 schools were randomised to treatment and 370 children (50.8%) at 47 schools to control. Among these, 679 children (93.3%) completed follow-up and underwent analysis. Spectacle wear in the treatment and control groups was 68.3% and 29.3% (p<0.001), respectively. Uncorrected final VA for eyes of treatment children was significantly better than control children, adjusting only for baseline VA (difference of 0.039 LogMAR units, 95% CI: 0.008, 0.070, equivalent to 0.39 lines, p=0.014) or baseline VA and other baseline factors (0.040 LogMAR units, 95% CI 0.007 to 0.074, equivalent to 0.40 lines, p=0.020).ConclusionWe found no evidence that spectacles wear worsens children’s uncorrected VA among urban migrant Chinese school children.

scholarly journals Efektivitas desloratadin terhadap skor gejala hidung total dan kadar interleukin-4 sekret hidung rinitis alergi

2018 ◽  
Vol 48 (1) ◽  
pp. 56
Author(s):  
Luh Putu Dhena Purwaningsih ◽  
Dwi Reno Pawarti ◽  
Bakti Surarso
Keyword(s):  
Clinical Trial ◽  
Atopic Disease ◽  
Randomised Clinical Trial ◽  
Current Treatment ◽  
Nasal Symptom ◽  
Nasal Secretion ◽  
Interleukin 4 ◽  
Control Group ◽  
Double Blind ◽  
Significant Difference

Latar belakang: Rinitis alergi (RA) adalah penyakit atopi yang umum terjadi, namun terapi yangtersedia mempunyai keterbatasan baik dalam penggunaan maupun angka keberhasilan. Desloratadinberperan sebagai terapi alternatif RA yang dapat menghilangkan keseluruhan gejala RA dan menurunkankadar interleukin-4 (IL-4) sekret hidung. Tujuan: Menganalisis efektivitas desloratadin dibandingkandengan loratadin dalam menurunkan skor gejala hidung total dan IL-4 sekret hidung pada penderita RA.Metode: Merupakan double blind randomised clinical trial with pre-post test design. Analisis data denganindependent sample t-test. Sebanyak 24 penderita RA dibagi menjadi 2 kelompok terapi yaitu kelompokstudi (desloratadin), dan kelompok kontrol (loratadin). Evaluasi berdasarkan skor gejala hidung total danIL-4 sekret hidung, pra dan pasca 15 hari terapi. Hasil: Penelitian yang dilakukan sejak bulan Juli sampaiOktober 2016 menunjukkan hasil berupa perbedaan bermakna rerata persentase penurunan skor gejalahidung total kelompok desloratadin dibandingkan kelompok loratadin (p=0,000). Perbandingan penurunankadar IL-4 sekret hidung antara kelompok desloratadin dengan loratadin adalah berbeda tidak bermakna(p=0,236). Kesimpulan: Penurunan skor gejala hidung total desloratadin lebih besar dibandingkan denganloratadin, dan tidak didapatkan perbedaan penurunan pada kadar IL-4 sekret hidung. ABSTRACTBackground: Allergic rhinitis (AR) is a common atopic disease but its current treatment is limitedboth in usage, as well as in the success rate. Desloratadine is an alternative choice in the treatment ofAR, and it could reduce the Interleukin (IL-4) nasal secretion level. Purpose: To assess the effectivenessof desloratadine compared to loratadine in decreasing total nasal symptom score (TNSS) and levels ofIL-4 nasal secretions in AR patients. Method: A double blind randomized clinical trial (RCT). Twentyfour AR patients were divided into two treatment groups: study group (desloratadin) and control group(loratadine). Evaluation was based on TNSS and IL-4 nasal secretion level pre and post 15 days oftreatment. Result: Conducted from July to October 2016, this study showed the mean of TNSS reductionpercentage between desloratadine group compared to loratadine group was significant (p=0.000).The comparison of reduction of IL-4 nasal secretion level between desloratadine group and loratadinegroup was not significantly different (p=0.236). Conclusion: The TNSS decreased more in desloratadinecompared to loratadine, but there was no significant difference between both groups in the levels of IL-4nasal secretions

scholarly journals A Phase 2 Randomised Clinical Trial Assessing the Tolerability of Two Different Ratios of Medicinal Cannabis in Patients With High Grade Gliomas

2021 ◽  
Vol 11 ◽  
Author(s):  
Janet Schloss ◽  
Judith Lacey ◽  
Justin Sinclair ◽  
Amie Steel ◽  
Michael Sughrue ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Grade Glioma ◽  
Randomised Clinical Trial ◽  
Trial Registration ◽  
Brain Morphology ◽  
Control Group ◽  
High Grade ◽  
Serious Adverse Events ◽  
Clinical Trial Registration ◽  
Medicinal Cannabis

BackgroundCannabis for cancer is very topical and, given the use of illicit cannabis preparations used in this vulnerable population, research investigating standardised, quality-assured medicinal cannabis is critical to inform clinicians and assist patient safety.MethodsA randomized trial involving adult patients diagnosed with a high-grade glioma, no history of substance abuse, liver or kidney damage or myocardial infarction were eligible for inclusion in a tolerability study on two different ratios of medicinal cannabis. Baseline screening of brain morphology, blood pathology, functional status, and cognition was conducted. A retrospective control group was used for comparison for secondary outcomes.ResultsParticipants (n=88) were on average 53.3 years old. A paired t-test assessed the Functional Assessment of Cancer Therapy for Brain Cancer (FACT-Br) between groups from baseline to week 12 found that the 1:1 ratio favoured both physical (p=0.025) and functional (p=0.014) capacity and improved sleep (p=0.009). Analysis of changes from baseline to week 12 also found 11% of 61 participants had a reduction in disease, 34% were stable, 16% had slight enhancement, and 10% had progressive disease. No serious adverse events occurred. Side effects included dry mouth, tiredness at night, dizziness, drowsiness.ConclusionThis study demonstrated that a single nightly dose of THC-containing medicinal cannabis was safe, had no serious adverse effects and was well tolerated in patients. Medicinal cannabis significantly improved sleep, functional wellbeing, and quality of life.Clinical Trial RegistrationAustralian New Zealand Clinical Trials Registry (ANZCTR) http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373556&amp;isReview=true, identifier ACTRN12617001287325.

Beneficial effects of pelvic floor muscle exercises on sexual function among postmenopausal women: a randomised clinical trial

Sexual Health ◽  
2018 ◽  
Vol 15 (5) ◽  
pp. 396 ◽  
Author(s):  
Soheila Nazarpour ◽  
Masoumeh Simbar ◽  
Hamid Alavi Majd ◽  
Fahimeh Ramezani Tehrani
Keyword(s):  
Clinical Trial ◽  
Sexual Function ◽  
Pelvic Floor ◽  
Postmenopausal Women ◽  
Pelvic Floor Muscle ◽  
Intervention Group ◽  
Randomised Clinical Trial ◽  
General Information ◽  
Control Group ◽  
Significant Difference

Background The adverse effects of menopause on sexual function could be mitigated by pelvic floor muscle (PFM) training. This study aimed to investigate the effects of PFM exercises on sexual function in postmenopausal women. Methods: A randomised clinical trial was conducted among 97 Iranian postmenopausal women, aged 40 to 60 years. The participants’ baseline sexual functions were assessed using the Female Sexual Function Index (FSFI) questionnaire. They were then randomly designated to two groups: (1) the intervention group, which received specific instructions on PFM exercises and was followed up on a weekly basis; and (2) the control group, which received general information on menopause. After 12 weeks, the sexual functions of the participants were reassessed. Results: No significant difference was initially observed between the two groups in terms of demographic and socioeconomic characteristics and total scores of FSFI. After the intervention, however, the scores of arousal, orgasm and satisfaction were significantly higher in the intervention group (3.10, 4.36, and 4.84 vs 2.75, 3.89, and 4.36 respectively; P < 0.05). Conclusion: PFM exercises have the potential to improve the sexual function of postmenopausal women and are thus suggested to be included in healthcare packages designed for postmenopausal women.

Comparison of the effects of intravenous propofol and propofol with low-dose ketamine on preventing postextubation cough and laryngospasm among patients awakening from general anaesthesia: A prospective randomised clinical trial

2020 ◽  
pp. 175045892091263
Author(s):  
Yanipan Chungsamarnyart ◽  
Jiranun Pairart ◽  
Sithapan Munjupong
Keyword(s):  
Clinical Trial ◽  
General Anaesthesia ◽  
Low Dose ◽  
Randomised Clinical Trial ◽  
Control Group ◽  
Significant Difference ◽  
Comparison Groups

Background Coughing and laryngospasm are undesirable consequences occurring when patients awaken from general anaesthesia. The objective of the study aimed to compare the effects of intravenous propofol and propofol with low-dose ketamine on preventing postextubation cough and laryngospasm. Methods In all, 120 patients scheduled surgery under general anaesthesia were randomly assigned into three groups. Patients in the control group (C-group) obtained intravenous 0.9% NaCl, while patients in the propofol group (P-group) obtained intravenous 0.25mg/kg propofol and patients in the propofol combined with ketamine group (PK-group) obtained intravenous 0.25mg/kg of propofol plus 0.15mg/kg of ketamine. Drugs were administered before extubation. Incidence and severity of coughing and laryngospasm were recorded by a blinded anaesthesiologist. Results Subjects of the PK-group (25%) experienced significantly reduced incidence of postoperative cough than that in the P-group (55%) and C-group (72.5%) (all P < 0.05). The severity of cough in the PK-group was significantly less than that in the P-group and C-group (P = 0.039 and P < 0.001, respectively). No significant difference was found in the incidence and severity of laryngospasm between comparison groups. Conclusion Intravenous combination of propofol and low-dose ketamine significantly reduced the incidence and severity among patients awakening from general anaesthesia.

Effects of nutrition education on cardio-metabolic outcomes: A randomised clinical trial

2019 ◽  
Vol 79 (4) ◽  
pp. 458-470
Author(s):  
Hildemar Dos Santos ◽  
W Lawrence Beeson ◽  
Gina Segovia-Siapco ◽  
Brenda Koranda ◽  
Tony Jehi
Keyword(s):  
Risk Factors ◽  
Clinical Trial ◽  
Health Education ◽  
Intervention Group ◽  
Density Lipoprotein ◽  
Randomised Clinical Trial ◽  
Metabolic Risk Factors ◽  
Lipoprotein Cholesterol ◽  
Control Group ◽  
Metabolic Risk

Objective: The aim of this study was to assess the effect of Full Plate Diet (FPD) on the primary prevention of cardio-metabolic risk factors. Design: Randomised clinical trial. Setting: Drayson Center, Loma Linda University, CA, USA. Methods: Forty individuals were randomly assigned to either an intervention group receiving the FPD health education for 10 weeks or to a control group not receiving this intervention. Comprehensive evaluations of clinical and anthropometric outcomes were conducted at baseline and at the end of intervention. To assess within-group changes and between-group differences, a general linear model was used. Results: Significant reductions in weight (−1.54 kg, 95% confidence interval [CI] −2.5, −.54) and total cholesterol (TC) (−11.7 mg/dL; 95% CI −21.4, −2) and non-significant reductions in means for low-density lipoprotein cholesterol (LDL-C) (−7.3 mg/dL, 95% CI −16, 1.5) and triglycerides (−18.7 mg/dL, 95% CI −46, 8.5) were observed in the intervention group after 10 weeks compared with baseline. These reductions were non-significantly higher in the intervention compared with the control group. There were no significant mean changes in systolic and diastolic blood pressure, high-density lipoprotein cholesterol (HDL-C) and haemoglobin A1c (A1c) in the intervention group after 10 weeks. Conclusion: A multi-component programme comprising 10 weeks of health education that emphasised the high intake of fibre failed to significantly reduce cardio-metabolic risk factors. It did show a downward trend in triglycerides, TC and body weight that may be of clinical importance suggesting that a future investigation with a longer intervention duration is needed.

scholarly journals LAVENDER ESSENTIAL OIL FOR SPINAL PAIN IN OBESE WOMEN: A CLINICAL TRIAL

2021 ◽  
Vol 20 (3) ◽  
pp. 192-196
Author(s):  
MARIANA FELIN CEREZER ◽  
SHEILA SPOHR NEDEL ◽  
MORGANA CHRISTMANN ◽  
LARISSA SANTOS NUNES ◽  
IGOR SOARES VIEIRA ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Essential Oil ◽  
Positive Impact ◽  
Intervention Group ◽  
Spinal Pain ◽  
Cervical Region ◽  
Control Group ◽  
Lumbar Region ◽  
Obese Women ◽  
Level Of Evidence

ABSTRACT Objective To analyze the effect of lavender essential oil associated with massage on spinal pain levels in obese women. Methods The sample included 49 obese women, between 20 and 60 years of age, randomly assigned to three groups: control (n=15), intervention (n=19) and placebo (n=15). The intervention and placebo groups were submitted to eight 35-minute sessions, twice a week for one month, but the essential oil of Lavandula angustifolia was used only in the intervention group. A placebo was used for the placebo group and the control group received no intervention. Pain levels were measured before and after the intervention using the Visual Analog Scale. Results There was a significant decrease in total spinal pain (p=0.004), in the cervical region (p=0.003) and in the lumbar region (p=0.008) in the intervention group. Conclusion Lavender essential oil had a positive impact on the reduction of pain in the spine of obese women, as well as in the specific areas of the cervical and lumbar regions compared to the control and placebo groups. Level of evidence I; Randomized clinical trial.

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