VETCOSED study: efficacy of compressive garments for patients with hypermobile Ehlers-Danlos syndrome on shoulder stability and muscles strength.

PURPOSE: to assess the effect of wearing a compressive short-sleeve jacket on shoulder stability and rotator muscles in adult patients with a hypermobile subtype of Ehlers-Danlos syndrome. MATERIALS AND METHODS: a quasi-experimental study with "Pre/Post" design (4 weeks with versus 4 weeks without), open, conducted on a national cohort. Shoulder rotators were assessed with an isokinetic device at 180°/s and 90°/s; frequency of shoulder stability defects, pain (Visual Analogical Scale), and satisfaction (Quebec User Evaluation of Satisfaction with Assistive Technology) were reported. RESULTS: 36 patients (35 women), mean age 37.9 years, wore jackets for a meanly 7.8 h/day. >70% were satisfied with the effect on arthralgia, instability, or function. QUEST results were high (m = 4.1, SD = 0.7). After jacket wear, the power of external rotators at 180°/s was significantly increased (+1.29 W, CI95%: 0.31; 2.28; p = 0.0318). At 90°/s, no significant difference was found, either on power or strength. The on-off effect highlights a significant difference in external and internal rotators power, whatever the speed. The occurrence of subluxation (p = 0.0140) and dislocations (p = 0.0163) decreased. Pain decreased from 3.5/10 to 2.5/10, without significance (p = 0.0964). CONCLUSION: compressive CICATREX SED® jackets are well supported by patients, impact the power of external rotators at high speed (180°/s), and improve joint stability.IMPLICATIONS FOR REHABILITATIONCompressive garments made to measure are beneficial to patients with hypermobile Ehlers-Danlos syndrome.Compressive CICATREX SED® jackets clearly improve shoulder stability and help to promote muscle power in shoulder external rotators during high-speed movements.One month of jacket wearing seems to bring no lasting effect on shoulder-rotator power, so the jacket needs to be kept on for the benefits to be maintained.

Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol.

INTRODUCTION: Intervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained impact on autism symptom reduction. However, access to such evidence-based therapies for families is limited due to autism centres located in large urban areas. Using videoconferencing to deliver PACT training to parents may improve accessibility for families living in underserved areas. METHODS AND ANALYSIS: This single-blind randomised controlled trial, involving six sites in France, will investigate the efficacy of a telehealth, videoconferencing-based, parent-mediated PACT therapy on autism symptoms, over a 12-month period. It will compare PACT plus treatment as usual (TAU) against TAU only in a cohort of 238 toddlers (119 per group) aged 18-36 months at inclusion and living with their families more than 40 min away from the specialist centres for autism. Primary outcome will include change of overall autism score on the Autism Diagnostic Observation Scale (ADOS) at 12 months. Secondary outcomes will measure change in child skills, child functioning, impact on parents (stress, health, priorities) and implementation characteristics. Repeated measures analyses will be used to test the effect of PACT intervention on the overall ADOS module 1 score over the 12-month study period. Linear mixed models will be used with time, treatment allocation and the interaction between treatment and time as fixed effects and individual variation as random effect. ETHICS AND DISSEMINATION: This protocol (V.5, date: 25 October 2019) is approved by the French National Review Board (reference no 2018-A02516-49). The results will be disseminated via peer-reviewed journals TRIAL REGISTRATION NUMBER: NCT04244721.

Impact of the Early Start Denver Model on the cognitive level of children with autism spectrum disorder: study protocol for a randomised controlled trial using a two-stage Zelen design.

INTRODUCTION: Early intervention for autism spectrum disorder (ASD) in the European French-speaking countries is heterogeneous and poorly evaluated to date. Early intervention units applying the Early Start Denver Model (ESDM) for toddlers and young children with ASD have been created in France and Belgium to improve this situation. It is essential to evaluate this intervention for the political decision-making process regarding ASD interventions in European French-speaking countries. We will evaluate the effectiveness of 12 hours per week ESDM intervention on the cognitive level of children with ASD, over a 2-year period. METHODS AND ANALYSIS: The study will be a multicentre, randomised controlled trial, using a two-stage Zelen design. Children aged 15-36 months, diagnosed with ASD and with a developmental quotient (DQ) of 30 or above on the Mullen Scale of Early Learning (MSEL) will be included. We will use a stratified minimisation randomisation at a ratio 1:2 in favour of the control group. The sample size required is 180 children (120 in the control and 60 in the intervention group). The experimental group will receive 12 hours per week ESDM by trained therapists 10 hours per week in the centre and 2 hours in the toddlers' natural environment (alternatively by the therapist and the parent). The control group will receive care available in the community. The primary outcome will be the change in cognitive level measured with the DQ of the MSEL scored at 2 years. Secondary outcomes will include change in autism symptoms, behavioural adaptation, communicative and productive language level, sensory profile and parents' quality of life. The primary analysis will use the intention-to-treat principle. An economic evaluation will be performed. DISSEMINATION: Findings from the study will be disseminated through peer reviewed publications and meetings. TRIAL REGISTRATION NUMBER: NCT02608333 (clinicaltrials.gov); Pre-results.

Long-term effectiveness of an educational and physical intervention for preventing low-back pain recurrence: a randomized controlled trial.

OBJECTIVE: Low-back pain (LBP) is a common and recurrent condition, but the evidence is scarce about effective strategies to prevent recurrence and disability in the longer term. This study investigated the effect of a light exercise program, initiated in the workplace and continued at home, in reducing recurrence of LBP episodes among healthcare workers. METHODS: A total of 353 healthcare workers from ten hospitals were enrolled in a randomized controlled trial (RCT) and were randomized to the intervention or control groups, the latter of which received usual care. The intervention comprised three steps: (i) a 2-hour education session, (ii) five weekly 90-minutes exercise training sessions in the workplace, and (iii) a home-based self-managed exercise program. The main outcome was recurrence of LBP with sick-leave at 24-months follow-up. RESULTS: At two-year follow-up, 35 workers (24%) in the intervention group and 31 workers (21%) in the control group had at least one LBP recurrence with sick leave. No effect was observed between groups [odds ratio (OR) 1.22, 95% confidence interval (95% CI) 0.67-2.23, P=0.516]. The intervention was effective in reducing fear avoidance with a mean reduction of -3.6 (95% CI -4.8- -2.4) points on the fear-avoidance beliefs questionnaire score for physical activity (FABQ-P) in the intervention group compared with -1.3 (95% CI -2.2- -0.3) points in the control group (P<0.05). It was also effective in improving muscle endurance with a mean increase of 13.9 (95% CI 3.3-24.5) minutes on the Sorensen test in the intervention group compared with -8.3 (95% CI-17.5-0.9) minutes in the control group (P<0.05). Healthcare utilization was reduced in the intervention group for painkillers, medical visits, imaging and outpatient physiotherapy. CONCLUSION: It was not possible to conclude about the effectiveness of a light exercise program to reduce LBP recurrence episodes in the long-term in healthcare workers. However, it was effective to improve muscle endurance, and to reduce fear-avoidance beliefs and healthcare utilization. Further studies are necessary in order to identify effective interventions to reduce LBP recurrence and related sick-leaves.

The PRESLO study: evaluation of a global secondary low back pain prevention program for health care personnel in a hospital setting. Multicenter, randomized intervention trial.

BACKGROUND: Common low back pain represents a major public health problem in terms of its direct cost to health care and its socio-economic repercussions. Ten percent of individuals who suffer from low back pain evolve toward a chronic case and as such are responsible for 75 to 80% of the direct cost of low back pain. It is therefore imperative to highlight the predictive factors of low back pain chronification in order to lighten the economic burden of low back pain-related invalidity. Despite being particularly affected by low back pain, Hospices Civils de Lyon (HCL) personnel have never been offered a specific, tailor-made treatment plan. The PRESLO study (with PRESLO referring to Secondary Low Back Pain Prevention, or in French, PREvention Secondaire de la LOmbalgie), proposed by HCL occupational health services and the Centre Médico-Chirurgical et de Réadaptation des Massues - Croix Rouge Française, is a randomized trial that aims to evaluate the feasibility and efficiency of a global secondary low back pain prevention program for the low back pain sufferers among HCL hospital personnel, a population at risk for recurrence and chronification. This program, which is based on the concept of physical retraining, employs a multidisciplinary approach uniting physical activity, cognitive education about low back pain and lumbopelvic morphotype analysis. No study targeting populations at risk for low back pain chronification has as yet evaluated the efficiency of lighter secondary prevention programs. METHODS/DESIGN: This study is a two-arm parallel randomized controlled trial proposed to all low back pain sufferers among HCL workers, included between October 2008 and July 2011 and followed over two years. The personnel following their usual treatment (control group) and those following the global prevention program in addition to their usual treatment (intervention group) are compared in terms of low back pain recurrence and the impairments measured at the beginning and the end of the study. The global prevention program is composed of a two-hour information session about low back pain and pain pathways, followed by five weekly 90-min exercise sessions with one physiotherapist per group of eight to ten personnel. A booklet for home use with patient-managed exercise instructions and information (The Back Book) is given to each participant at the end of the program.An X-ray assessment of the entire spinal column of each participant (in both the control and intervention groups) is performed at the onset of the study in order to analyze sagittal spinopelvic balance as well as lombopelvic morphotype. DISCUSSION: The results of this study, which is innovative and unique in France, will be available in 2014 and will make it possible to draw conclusions regarding the program's impact on the risk of recurrence and chronification of low back pain. TRIAL REGISTRATION: http://www.clinicaltrials.gov # NCT00782925.