The RESOLVE Trial for people with chronic low back pain: Statistical analysis plan

Background: Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control. Results: We report the planned data management and analysis for the primary and secondary outcomes. The primary outcome is pain intensity at 18-weeks post randomization. We will use mixed-effects models to analyze the primary and secondary outcomes by intention-to-treat. We will report adverse effects in full. We also describe analyses if there is non-adherence to the interventions, data management procedures, and our planned reporting of results. Conclusion: This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial. Trial registration: ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/ TrialReview.aspx?id=368619). © 2020 Associac¸ao˜ Brasileira de Pesquisa e Pos-Graduac ´ ¸ao˜ em Fisioterapia. Published by Elsevier Editora Ltda. All rights reserved

Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial

BackgroundAnterior cruciate ligament (ACL) rupture is a common debilitating injury that can cause instability of the knee. We aimed to investigate the best management strategy between reconstructive surgery and non-surgical treatment for patients with a non-acute ACL injury and persistent symptoms of instability.MethodsWe did a pragmatic, multicentre, superiority, randomised controlled trial in 29 secondary care National Health Service orthopaedic units in the UK. Patients with symptomatic knee problems (instability) consistent with an ACL injury were eligible. We excluded patients with meniscal pathology with characteristics that indicate immediate surgery. Patients were randomly assigned (1:1) by computer to either surgery (reconstruction) or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment), stratified by site and baseline Knee Injury and Osteoarthritis Outcome Score—4 domain version (KOOS4). This management design represented normal practice. The primary outcome was KOOS4 at 18 months after randomisation. The principal analyses were intention-to-treat based, with KOOS4 results analysed using linear regression. This trial is registered with ISRCTN, ISRCTN10110685, and ClinicalTrials.gov, NCT02980367.FindingsBetween Feb 1, 2017, and April 12, 2020, we recruited 316 patients. 156 (49%) participants were randomly assigned to the surgical reconstruction group and 160 (51%) to the rehabilitation group. Mean KOOS4 at 18 months was 73·0 (SD 18·3) in the surgical group and 64·6 (21·6) in the rehabilitation group. The adjusted mean difference was 7·9 (95% CI 2·5–13·2; p=0·0053) in favour of surgical management. 65 (41%) of 160 patients allocated to rehabilitation underwent subsequent surgery according to protocol within 18 months. 43 (28%) of 156 patients allocated to surgery did not receive their allocated treatment. We found no differences between groups in the proportion of intervention-related complications.InterpretationSurgical reconstruction as a management strategy for patients with non-acute ACL injury with persistent symptoms of instability was clinically superior and more cost-effective in comparison with rehabilitation management

Attitudes to Organ Donation and Knowledge of Donation and Transplantation among University of Auckland Medical Students

Aims • To explore organ donation and transplantation knowledge and attitudes among medical students at the University of Auckland. • To understand students' perception of the extent of training received prior to and during the medical program. Method A validated web-based questionnaire consisting of 42 questions in five categories was anonymously administered to all enrolled medical students at the Faculty of Medical and Health Sciences, University of Auckland, in September 2012. Results In all, 419 out of 989 (42%) Year 2–6 students responded. A total of 99.3% of medical students supported organ donation, but knowledge was limited (mean score 7.54/15±2.26). A total of 38% of students reported having participated in organ donation learning. A total of 96% of students believed that organ donation information should be available in primary care settings. A total of 69% of students reported that if a patient asked a question about organ donation that they did not know the answer to, they also would not know where to source the correct information from. Conclusion This study demonstrates that although medical students support organ donation, they lack the knowledge required to facilitate informative discussions with patients. Enhanced organ donation education in medical programs may enable students to develop skills and knowledge allowing them to better discuss donation with patients

The independence of deficits in position sense and visually guided reaching following stroke

Article deposited according to agreement with BMC, December 2, 2010 and according to publisher policies: http://www.biomedcentral.com/about/copyright [May 31, 2013].YesFunding provided by the Open Access Authors Fund

The independence of deficits in position sense and visually guided reaching following stroke

Abstract Background Several studies have found correlations between proprioception and visuomotor function during stroke recovery, however two more recent studies have found no correlation. Unfortunately, most of the studies to date have been conducted with clinical assessments of sensation that are observer-based and have poor reliability. We have recently developed new tests to assess position sense and motor function using robotic technology. The present study was conducted to reassess the relationship between position sense and upper limb movement following stroke. Methods We assessed position sense and motor performance of 100 inpatient stroke rehabilitation subjects and 231 non-disabled controls. All subjects completed quantitative assessments of position sense (arm-position matching task) and motor performance (visually-guided reaching task) using the KINARM robotic device. Subjects also completed clinical assessments including handedness, vision, Purdue Pegboard, Chedoke-McMaster Stroke Assessment-Impairment Inventory and Functional Independence Measure (FIM). Neuroimaging documented lesion localization. Fisher’s exact probability tests were used to determine the relationship between performances on the arm-position matching and visually-guided reaching task. Pearson’s correlations were conducted to determine the relationship between robotically measured parameters and clinical assessments. Results Performance by individual subjects on the matching and reaching tasks was statistically independent (Fisher’s test, P Conclusions Our data support the concept that position sense deficits are functionally relevant and point to the importance of assessing proprioceptive and motor impairments independently when planning treatment strategies.</p

Subluxação glenohumeral na hemiplegia

Malalignment, most commonly, inferior subluxation, is a common and troublesome complication of hemiplegia. Altered scapular and humeral positions have been implicated as a causative factor in glenohumeral subluxation, contributing to upper extremity pain and malalignment. The purpose of this study was to evaluate the relationship between scapular and humeral positions and glenohumeral subluxation in two groups of hemiplegic patients, one with low tone or flaccid paralysis and the other with high tone or spasticity. Thirty-four hemiplegic subjects (17 in each group) participated in this study, ranging in age from 41 to 89 years. Radiographs of the affected shoulder were taken in order to evaluate glenohumeral subluxation. The 3Space Isotrak, an electromagnetic device, was used to obtain the tridimensional co-ordinates of bony landmarks located on the scapula, humerus and vertebral column. Glenohumeral subluxation was significantly greater in the low tone group (0,52 ± 0,38 cm) compared to the high tone group (0,21 ± 0,41 cm) ( p p &lt; 0.05). There was no correlation between scapular and humeral orientation and glenohumeral subluxation vvithin groups and across subjects, hi the low tone group, the scapular abduction angle (AbSc) was significantly lower on the affected side compared to the non-affected side. No significant difference was found in the abduction angle of the humerus (AbH) or in the humeral angle relative to the scapula (HRel). No significant differences were found between the affected and nonaffected sides when the scapular and humeral orientation measures were compared in the high tone group.Subluxação inferior do úmero é uma alteração comum do complexo articular do ombro que aflige a maioria dos pacientes com história de Acidente Vascular Cerebral. As alterações do complexo articular do ombro têm sido propostas como um fator importante na contribuição da subluxação glenohumeral. Este estudo tem como objetivo avaliar a relação entre a orientação escapular e umeral e a subluxação glenohumeral em dois grupos de pacientes hemiplégicos; um grupo com paralisia flácida e outro com paralisia espástica de membro superior. Trinta e quatro pacientes hemiplégicos (17 em cada grupo), idade média entre 41 e 89 anos, participaram desse estudo.' Radiografias do ombro afetado foram obtidas com o objetivo de avaliar o grau de subluxação inferior do úmero. O 3 Space Isotrak, um equipamento eletromagnético, foi usado na obtenção das coordenadas em 3 dimensões da escapula e úmero. A subluxação glenohumeral foi significativamente maior no lado afetado do grupo flácido (0,52 ± 0,38 cm) do que no grupo espástico (0,21 ± 0,41 cm) (p &lt; 0,05). Nenhuma relação significativa foi identificada entre o ângulo de abdução escapular e subluxação umeral tanto no grupo flácido (r = -0,121; p = 0,6) quanto no grupo espástico (r = -0,221; p = 0,4). As medidas -de orientação umerais também não apresentaram qualquer correlação significativa com o grau de subluxação inferior do ombro em ambos os grupos. Este estudo não fornece suporte para o conceito de que a rotação inferior da escapula contribui para a subluxação inferior do úmero na hemiplegia

O complexo articular do ombro na hemiplegia

Clinical observations indicate that the resting position of the scapula and humerus are altered in both the flaccid and spastic stage of recovery following Cerebrovascular Accident contributing to upper extremity pain and dysfunction. The purpose of this study was to compare scapular and humeral position between the affected and non-affected side in two groups of hemiplegic subjects, one with low tone or flaccid paralysis and the other with high tone or spasticity. Thirty-four hemiplegic subjects (17 in each group), participated in this study, ranging in age from 41 to 89 years. The 3Space Isotrak, an electromagnetic device, was used to obtain the tridimensional coordinates of bony landmarks located on the scapula, humerus and vertebral column. Data were collected with subjects seated on a stool with arms relaxed by the side. Linear and angular measures of scapular and humeral orientation were calculated from the co-ordinates. In the low tone group, scapular abduction angle (AbSc) was significantly lower on the affected side compared to the non-affected side. The scapula was further from the midline and lower on the thorax. No significant difference was found in the abduction angle of the humerus (AbH) or in the humeral angle relative to the scapula (HRel). No significant differences were found between the affected and non-affected sides in either the angular or linear measures of scapular and humeral orientation in the high tone group.Observações clínicas indicam que tanto na fase flácida quanto na fase espástica de um pós Acidente Vascular Cerebral (AVC), a posição de repouso da escapula e do úmero estão alteradas, possivelmente contribuindo para dor e mau alinhamento do membro superior. O objetivo deste estudo foi comparar a orientação escapular e umeral entre o lado afetado e o não afetado em dois grupos (flácido e espástico) de pacientes hemiplégicos. Trinta e quatro pacientes hemiplégicos (17 em cada grupo), idade média entre 41 e 89 anos, participaram deste estudo. O 3 Space Isotrak, um equipamento eletromagnético, foi usado na obtenção das coordenadas tridimensionais das proeminências ósseas localizadas na escapula, úmero e coluna vertebral. Os dados foram coletados com o paciente sentado num tamborete com os braços relaxados ao lado. Medidas lineares e angulares da orientação da escapula e do úmero foram calculadas através das coordenadas. No grupo flácido, o ângulo de abdução escapular (AbSc) foi significativamente mais baixo no lado afetado comparado com o lado não afetado. A escapula estava distante da linha média e baixa no tórax. Nenhuma diferença significativa foi encontrada entre o ângulo de abdução do úmero (AbH) e o ângulo de abdução do úmero relativo à escapula (HRel). Nenhuma diferença significativa foi encontrada entre os lados afetado e não afetado nos pacientes do grupo espástico, quando as medidas lineares e angulares de orientação da escapula e do úmero foram comparadas. Este estudo fornece pouca evidência de um padrão consistente na orientação esquelética da escapula e úmero, principalmente em pacientes com espasticidade

A postural unloading task to assess fast corrective responses in the upper limb following stroke

Abstract Background Robotic technologies to measure human behavior are emerging as a new approach to assess brain function. Recently, we developed a robot-based postural Load Task to assess corrective responses to mechanical disturbances to the arm and found impairments in many participants with stroke compared to a healthy cohort (Bourke et al, J NeuroEngineering Rehabil 12: 7, 2015). However, a striking feature was the large range and skewed distribution of healthy performance. This likely reflects the use of different strategies across the healthy control sample, making it difficult to identify impairments. Here, we developed an intuitive “Unload Task”. We hypothesized this task would reduce healthy performance variability and improve the detection of impairment following stroke. Methods Performance on the Load and Unload Task in the KINARM exoskeleton robot was directly compared for healthy control (n = 107) and stroke (n = 31) participants. The goal was to keep a cursor representing the hand inside a virtual target and return “quickly and accurately” if the robot applied (or removed) an unexpected load to the arm (0.5–1.5 Nm). Several kinematic parameters quantified performance. Impairment was defined as performance outside the 95% of controls (corrected for age, sex and handedness). Task Scores were calculated using standardized parameter scores reflecting overall task performance. Results The distribution of healthy control performance was smaller and less skewed for the Unload Task compared to the Load Task. Fewer task outliers (outside 99.9 percentile for controls) were removed from the Unload Task (3.7%) compared to the Load Task (7.4%) when developing normative models of performance. Critically, more participants with stroke failed the Unload Task based on Task Score with their affected arm (68%) compared to the Load Task (23%). More impairments were found at the parameter level for the Unload (median = 52%) compared to Load Task (median = 29%). Conclusions The Unload Task provides an improved approach to assess fast corrective responses of the arm. We found that corrective responses are impaired in persons living with stroke, often equally in both arms. Impairments in generating rapid motor corrections may place individuals at greater risk of falls when they move and interact in the environment