ANZCTR search results

To compare the effectiveness of progressive resistance training and functional training versus functional training alone for increasing strength in partially-paralysed muscles in people with recent SCI. The results of this trial will have implications for the rehabilitation of people following SCI. In particular, the results will determine whether time and effort should be devoted to progressive resistance training programs or whether functional training alone will suffice.

This study will examine the effectiveness of telehealth to reduce utilisation of external health services by residents in long term care. These services include visits to emergency departments, hospital admissions and visits to specialists in an ambulatory clinic settings. The model under scrutiny involves geriatrician and gerontic nurse supported comprehensive geriatric assessment and care planning, supplemented by a wide range of telehealth enabled specialist disciplines, into the residential aged care setting. It is designed to address a series of problems encountered by clinicians and administrators within Residential Aged Care Facilities (RACF) in Australia, including inadequate access to specialists; professional isolation of nurses; sub-optimal care standards; and avoidable use of hospital services in emergencies. In this introductory section, these issues are delineated and the service model designed to overcome them is described.

Stroke survivors with poor balance and walking impairments have low activity levels and are at risk of falls. Targeted exercise can improve mobility. However, the absence of dose-finding studies may explain the limited effects of exercise delivered in many trials. In this dose-escalation study, we tested the feasibility of using dose-escalation methods, common in Phase 1 pharmaceutical trials, to determine the maximum tolerable dose of exercise in chronic stroke survivors with substantial mobility impairment.

The effect of training on the reliability of a satiety panel has not previously been reported. The aim was to compare the effect of a training intervention in the correct use of a satiety labeled magnitude scale versus no-training on the test-retest precision and reliability of 2 hr post-prandial satiety evaluation after consumption of a standard breakfast.The training exercise will enable the selection a panel to evaluate differences in the satiety of different fibres. The primary aim of this study is to investigate if training satiety panelists in the interpretation and use of the satiety line-scale could improve the test-retest precision and reliability of satiety response to a standard breakfast meal using a parallel intervention of either (i) training or (ii) no-training. A secondary aim is to compare the postprandial glycaemia and satiety effect of a breakfast meal containing viscous fibre PGX or two non-viscous dietary fibres, inulin and wheat dextrin using the trained satiety panel from arm 1.

Osteoarthritis (OA) is a major and costly cause of chronic musculoskeletal pain and disability in Australia. Patient self-management strategies are urgently needed. In knee OA, increased joint loading (forces acting across the joint) leads to worse knee pain and progressive structural joint deterioration. This project will investigate the impact of daily cane use, an easy and inexpensive self-help tool known to unload the knee, applied for 3 months on bone marrow lesion size on MRI in people with medial knee OA.

The Circle of Security parent DVD training is an 8-week relationship-based group program designed to enhance the parent-child relationship and attachment. We aim to examine the effectiveness of the DVD-based program for enhancing the parent-child relationship with multiproblem families, as well as improve other symptoms, such as parental mental health, and child internalizing and externalizing symptoms. Given the suggestion that group-based interventions may not be suitable for at risk families, we will examine the suitability of modifying the DVD protocol for use on an individual basis. Participants will be parents with a child aged 12-months to 6-years. Parents will be randomly assigned to one of two groups: (1) Circle of Security intervention or (2) supported waitlist control. The intervention group will complete the 8-week COS protocol involving one weekly 1-1.5 hour session with a trained Circle of Security facilitator. Parents in the waitlist control group will receive weekly supportive phone contact.

Depressive disorders in adolescents are common, disabling and at times life-threatening conditions. Safe and effective biological treatments are few. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive intervention, in which a potent and brief magnetic pulse is generated by an external coil applied to the scalp. rTMS has a remission rate when used in depressed adults of 30% to 40%. The Food and Drug Administration (FDA) approved rTMS for use in depressed adults in 2008. While rTMS has been shown to be safe and effective in adults, there is very limited information about the safety or efficacy of rTMS in depressed adolescents. This is a pilot study to explore the safety and effectiveness in the use of rTMS for adolescents with Major Depressive Disorder. In the proposed study, we will investigate the relative efficacy of low frequency right-sided rTMS compared with high frequency left-sided rTMS for depressed adolescents. It is hypothesized that left-sided high frequency TMS and right-sided low-frequency TMS will be of similar therapeutic benefit in the treatment of adolescent patients with Major Depressive Disorder. It is believed that there will be minimal side effects with overall benefits in depressive and anxiety symptoms. The study will involve 40 adolescent participants with MDD diagnosed by a trained clinician. The 40 participants will be randomly allocated to one of either low frequency right-sided rTMS (20 subjects) or high frequency left-sided rTMS (20 subjects). Both groups of subjects will receive daily treatment for 5 days per week, over 4 weeks (20 sessions) with the respective treatment. Following initial treatment, responders to this will be followed up following treatment and one month after the end of treatment with Children Rating Scale Revised.

Preterm birth (<34 weeks’ gestation) increases the risk for impairments in physical, mental health and academic functioning in children compared with term controls, with approximately 50% of preterm children affected. An estimated 40% of mothers of preterm infants report significant symptoms of depression, and many parents report an ongoing negative influence of preterm birth on family functioning. This important pilot study will evaluate the efficacy of the first web based intervention designed to promote child development and parental mental health for parents with infants born <34 weeks’ gestation. The primary aim of this randomised controlled trial is to assess the efficacy of a web-based intervention (e-prem) compared with standard care on child cognitive development at 24 months’ corrected age. Secondary outcomes of child behaviour and parent mental health will be compared between groups. e-prem is a web-based program with age-dependent content completed by parents from birth (starting in the neonatal intensive care unit) to the child’s first birthday (corrected). The program includes activities, resources, and an individualised fortnightly-monthly session over the phone. This study will recruit 100 infants born <34 weeks’ gestation (and their primary caregivers) from the Royal Women’s Hospital in Melbourne, Victoria. Families will be randomly allocated to either the intervention group and participate in the e-prem program, or control group and receive standard care. Child cognitive development will be assessed at 24 months’ corrected age. Primary caregivers will complete questionnaires on symptoms of anxiety and depression at recruitment, when infants are 12 months’ corrected age (post-intervention), and 24 months’ corrected age. Primary caregivers will complete questionnaires on child social-emotional development at 24 months’ corrected age. The parent-child relationship will be assessed at 12 months' corrected age. Program costs will be calculated. Outcomes will be compared between intervention and control groups.

The study is evaluating the safety, tolerability, and immunogenicity of ABP 710 in healthy subjects compared with US Food and Drug Administration (FDA)-licensed Infliximab and European Union (EU)-authorized Infliximab. Who is it for? You may be eligible to join this study if you are a healthy male and female subjects 18 to 45 years of age, inclusive. Non-Japanese subjects will have a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Japanese subjects must be first- or second-generation Japanese and have a BMI of 18.0 to 25.0 kg/m2, inclusive. Trial details Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group will receive 5mg/kg of ABP 710 (100mg vial) intravenously once only. Participants in the second group will receive 5mg/kg2 of FDA-licensed Infliximab (100mg vial) intravenously. Participants in the third group will receive 5mg/kg2 of EU-authorised Infliximab (100mg vial) intravenously. All participants will be followed-up at 57 days post allocation to one of the three drugs used in this trial.

Spinal cord stimulation (SCS) is a minimally invasive procedure used for the treatment of persistent, refractory and neuropathic pain. Conventional SCS systems require regular manual adjustments of the level of electrical stimulation after initial programming. These adjustments are necessary because the level of the spinal cord stimulation is dependent on the distance between the spinal cord and the implanted electrodes, which changes with patient’s daily activity (e.g., standing, lying down, seating, etc.). When a patient changes body position, the movement of the spinal cord relative to the implanted lead may result in uncomfortable or inconsistent stimulation. This may lead to suboptimal pain control and significantly reduce the effectiveness of the SCS therapy, which may impact heavily on patient’s quality of life. For instance, one of the most important daily activities – sleep, may be significantly affected by the inconsistent stimulation. This may compromise effective treatment and lead to increase in the levels of dissatisfaction and pain. The RestoreSENSOR (Medtronic Inc, USA) is the first in its class implantable pulse generator for spinal cord stimulation that automatically changes stimulation settings in response to position changes and provides objective patient activity data. It achieves this thanks to the inbuilt acceleration sensor that enables continuous motion sensing. The Medtronic RestoreSENSOR neurostimulator also records and stores the frequency of patient’s posture and activity changes. These objective data can be used by the clinician to understand whether the patient’s individual stimulation requirements are changing over time. If the SCS therapy with RestoreSENSOR improves patients’ quality of sleep and activity levels in this study, this will demonstrate superior effectiveness of position-adaptive stimulation technology in providing pain relief and convenience to patients suffering from chronic pain. Improvement in quality of sleep and daily activity levels will serve as an indicator of efficacy of the treatment.