ANZCTR search results

Lower limb pathology is the most common form of disability among sporting populations, accounting for over 50% of all sporting injuries. Taping is routinely recommended with the expectation it restricts joint range of motion, and therefore reduces the risk of injury. While the effects of taping have been well investigated in the literature, gaps still exist around the effect of ankle strapping on knee function, and whether ankle movement increases as strapping tape fatigues. Gaining a better understanding of the relationship ankle strapping has with knee function, and whether fatigued strapping tape has the ability to limit ankle range of motion. As the current research has many limitations and inconsistencies, the findings may enable better decision making by practitioners looking to prevent lower limb injuries. This study has been developed with two aims: 1) To inform athletes, and those working with athletes, about the impact of tape fatigue on tapes role as an injury prevention method, and 2) To inform athletes, and those working with athletes, about the impact of ankle tape on knee mechanics.

The purpose of this project is to test the addition of a new treatment called denosumab to standard immunotherapies for patients with metastatic melanoma. Denosumab has been used for many years to help treat cancers such as prostate cancer and breast cancer, but it is not currently used in melanoma. We hope the addition of denosumab to current melanoma therapies will make these treatments work better without adding to the side effects. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with metastatic melanoma (melanoma that has spread). Study details Nivolumab and ipilimumab are approved treatments for advanced melanoma in Australia and overseas. Patients with metastatic melanoma, who are not enrolled in a study, are commonly prescribed nivolumab alone or the combination of nivolumab and ipilimumab as standard care. However, there is limited information on the effectiveness and safety of these treatments in combination with denosumab. Recent melanoma research in animal models has shown that denosumab can make immunotherapies such as ipilimumab and nivolumab work better. Because denosumab has been used in patients with breast and prostate cancer for a long time and is safe, we now want to test the benefits and safety of adding denosumab to immunotherapies in this study. Patients in Arm A will receive nivolumab 3 mg/kg IV (intravenous) every 2 weeks for 4 doses and denosumab 120 mg SC (subcutaneous) D1, D8, D15, D29. Thereafter, nivolumab 480 mg IV and denosumab 120 mg SC every 4 weeks for a total of 24 months Patients in Arm B will recieve ipilimumab at 3 mg/kg combined with nivolumab at 1 mg/kg IV every 3 weeks for 4 doses with denosumab 120 mg SC given D1, D8, D15, D29, D57. This will be followed by nivolumab 480 mg IV and denosumab 120 mg SC ever 4 weeks for a total of 24 months. Responses to treatment and progression will be regularly monitored until the last patient has been in survival follow-up for 5 years. Tumour and blood samples will also be taken to determine possible predictive biomarkers.

Atrial fibrillation (AF) is a fast irregular heart rate that can cause abnormalities in the structure and electrical function of the heart and can cause strokes through formation of blood clots in the heart which move to the brain. A stroke is when blood flow to the brain is interrupted. Although AF is known to increase the risk of stroke, there is new evidence that suggests that other factors may be independently present that cause formation of blood clots in the heart leading to a stroke. The primary purpose of this study is to identify changes in structure of the heart, the electrical properties within the heart and in the blood chemistry that might increase a person’s risk for having a stroke.

Background: Increasing referrals and competing demands for limited resources are challenges faced by many government and non-government early intervention (EI) services. and the metropolitan Child Development Service (CDS) of Perth, Western Australia is no exception. CDS is a publically funded agency that forms part of Child and Adolescent Community Health and provides services for approximately 20,000 children with developmental delay and/or disability across the metropolitan region. In recent years referrals have increased significantly, and are expected to rise further due to migration and increased birth rates which can impact negatively on waiting lists. Operating with waiting lists is a problem many EI organisations face which has resulted in pressure to consider alternative models of delivering services to enable vulnerable children and families to access critical services in a timely way. Playgroups are used throughout the community to increase community engagement and parenting capacity whilst promoting children’s development through developmentally appropriate play. Therapeutic playgroups target families and children with specific risk factors or identified developmental delays/disabilities and aim to provide support and information specific to the child’s needs. They have been shown to have positive impacts on both caregiver and child outcomes. Objective: To evaluate a therapeutic playgroup protocol for children and families when first referred to CDS. Project Plan: This project will aim to develop, test and evaluate the playgroup protocol. This will include; focus groups and collection of demographic and descriptive data a playgroup working group, a pilot trial to assess feasibility and acceptability of the playgroup intervention and a randomised controlled trial to evaluate playgroup effectiveness compared to usual care. Prior to this a scoping review was conducted to identify key elements of playgroups from the literature.

To reduce breastfeeding complications in mothers of preterm infants by initiating expressing and massage within the first hour of birth as compared to one to six hours of birth or later. A pilot RCT will be used to inform the study methods to design a larger RCT.

Australian and international research has found that same-sex attracted women (SSAW) are more likely to drink at higher levels than heterosexual women. Yet despite this evidence, limited research has focused on interventions specifically for SSAW to facilitate alcohol reduction. The absence of evidence-based services for SSAW is problematic as the current mainstream services assume the needs of SSAW match those of heterosexual women. Consequently, many SSAW are not receiving appropriate treatment and are left feeling frustrated and invisible. Therefore, this project will explore the efficacy of a short message service (SMS) intervention tailored to SSAW to reduce alcohol use, improve well-being, and increase help-seeking. To do this, two studies are proposed. The first study was approved by Deakin University Human Ethics Advisory Group, Faculty of Health (reference number HEAG-H 111_2016). It involved developing the content for the SMS alcohol intervention tailored to SSAW by designing and presenting SMS messages and the structure of the SMS intervention to two focus groups of SSAW, and using their feedback to inform the final SMS messages and intervention. The second study will involve conducting a Randomised Controlled Trial to implement and evaluate the intervention. This trial registration pertains to the second study; that is, the implementation and evaluation of the SMS alcohol intervention tailored to SSAW. The intervention and control groups will receive messages for four weeks and will provide follow-up data relating to their alcohol two time points after they have completed the intervention - post-intervention and 12 week follow-up. It is hypothesised that participants receiving the SMS alcohol intervention will report lower alcohol intake at intervention completion and 3 months post intervention than participants not receiving the SMS alcohol intervention.

Study design: Prospective, multi-centre, randomised, clinical study. The study will enrol 100 patients over a 12-month recruitment period between surgeons at up to three centres. Objectives: To determine the relationship between Surgical Technique (workflow) and patient reported outcomes after total knee arthroplasty (TKA) utilising computer navigation, comparing tibia cut first with ligament balancing technique to measured femoral cuts technique. To investigate if patient range of motion and component alignment is affected by the order of workflow. To investigate if the order of surgical cuts during total knee replacement affects other parameters such as patient satisfaction. The study will also demonstrate safety, and equivalent clinical outcomes on pain and function to other published data. Groups: Apex Total Knee Replacement using Computer Navigation utilising Tibial Cut First. Apex Total Knee Replacement using Computer Navigation utilising Measured Femoral Cuts First. Number of subjects to be enrolled: 100 patients will be enrolled into this study. Medical Devices: The Apex Knee is intended for use as a primary total knee replacement device consisting of a femoral, tibial, tibial bearing and optional patellar component. The BTS G-walk is a wireless sensor that is placed around the waist with an ergonomic belt to analyse the walking pattern. Regulatory status: The Apex Knee is CE marked, TGA approved and has a rebate code on the Prostheses List. Clinical evaluations: Standard, functional parameters will be assessed preoperatively, and post-operatively at 6 weeks, 3months, 1 year, 2years. Published early results at 1 year then mid-term and long term results after 2 and more years Patient outcome assessments: The Oxford Knee Score and RAND SF36 operatively at 6 weeks, 3months, 1 year and 2 years. Radiographic evaluations: X-Rays will be assessed pre-operatively, post-operatively, at 12 months and 2 years to evaluate femoral and tibial components orientation and inclination.

FitSkills is an exercise program that matches a young person with disability with a mentor and the pair exercise together at their local gym, for an hour, twice a week for 12 weeks. The program comprises individually tailored exercise and information about on-going participation in exercise. Together with 7 partner organisations, we will complete a research translation project through a stepped wedge cluster randomised trial using a cohort design, with embedded health economics evaluation. The trial design sequentially introduces FitSkills to 8 sites in random order. After a control period, at regular intervals sites are randomised to cross from control to intervention phase until all sites have implemented FitSkills. We will recruit 160 youth with disability (any type) aged 13-30 years through our partner organisations. Data collection at 8 time points will continue throughout the trial at 3-month intervals (i.e. an assessment is conducted every 3 months for 24 months). We will collect data on: participant demographics and socioeconomics; participation; health-related quality of life; physical activity; attitudes to exercise; walking capacity; program feasibility; and attitudes to disability for mentors, gym staff and gym patrons at the participating sites.

Older people in hospital are commonly prescribed multiple medicines, some that may cause side effects such as drowsiness, confusion, dry eyes. dry mouth, constipation and falls. The Drug Burden Index (DBI) is used to find out if the medications being prescribed might impact on a person's day-to-day activities. It takes into account all the medications that someone is using; in particular the medicines that cause sleepiness and side effects like dry mouth and confusion. If someone has a high score on the DBI, there is a higher risk of falls, frailty, hospitalisation, more visits to their local doctor, and overall poorer outcomes. We hypothesise that there is a missed opportunity in hospital to identify and reduce the burden of medications in older people which can be addressed using the DBI. The primary purpose of this study is to find out what happens in hospital when the pharmacist provides a report on the DBI to a patient's treating doctors, mainly to see if the report changes the medicines that the doctors prescribe. We will also look at patients' outcomes, like falls and repeat hospital visits, as well as ask staff and patients for their opinions of the report.

This study is to measure the effect of a functional balance training program on gait, endurance, balance and fatigue in people with MS performed by the participant in a group setting or by the participant independently at home twice per week. The secondary aim is to investigate any predictors of adherence to exercises.