ANZCTR search results

The study will provide a full cognitive assessment of patients with MCI to confirm their diagnosis and likely underlying cause. There are three specific aims of the project: 1. Establish a cohort of well-characterised patients with neurodegenerative diseases presenting as mild cognitive impairment (MCI). 2. Create a repository of blood, brain imaging (MRI & PET) and CSF data for biomarker studies. 3. Implement a clinical model to increase physician referrals to clinical trials, through access to advanced imaging, neurocognitive screening, and cognitive neurologist assessments for people residing in the South Eastern part of Melbourne and rural areas in Victoria. The study will allow us the opportunity to collect a large database of MCI patients to gain greater insights in to risks, diagnosis and prognosis of the disease. Simultaneously it will provide patients with a clearer understanding of their disease (through use of research only tools) and increase referrals in to clinical trials of potentially beneficial treatments for patients with MCI.

LEGO® therapy is a proven intervention that uses a child’s natural interest to motivate learning and to collaboratively build a LEGO® set with others through the social division of labour.. It has been found to be effective in increasing social skills and reducing maladaptive behaviours in younger children with autism spectrum disorder (ASD), however, there is limited information about the effectiveness of LEGO® therapy for children over the age of 13 years. LEGO® robotics therapy – which uses the principles of LEGO® therapy applied to LEGO® robotics – may be an age-appropriate intervention to reduce anxiety and increase social skills in adolescents with ASD. The primary aim of this Phase 1 clinical trial is to investigate whether LEGO® robotics therapy can reduce anxiety and increase social skills and school engagement in adolescents aged 13-16 years with ASD. The second aim is to measure the engagement, utility, and acceptance of LEGO® robotics with this cohort, while the third aim is to formally gather the views and perceptions of the intervention from all stakeholders (adolescents with ASD, parents, teachers, and LEGO® therapist/facilitators). The fourth and final aim is to develop a training manual for school staff and parents to support adolescents with ASD. The manual would support the reach, generalisation and longevity of the LEGO® robotics therapy program across educational, clinical, home and community settings. The findings of this study will inform the development of a larger randomised controlled trial.

This is a phase 1, single-center, randomized, open-label, 3-way crossover study to evaluate the pharmacokinetics of PBT434 after administration of a tablet formulation in the fed and fasted states and a powder in capsule formulation which has been utilized in previous Phase 1 investigations

Proximal hamstring origin tendinopathy (PHT) is a common condition in the active and sporting population, particularly in sports involving sprinting, jumping, kicking or distance running. It was first described in 1988 (Puranen & Orava, 1988) as ‘Hamstring Syndrome’. The condition presents as localized lower buttock pain, and is typically aggravated by prolonged sitting, running or walking (particularly uphill), lunging and squatting. The primary aim of this study is to compare the immediate effect of isometric and isotonic exercise on pain and strength in individuals with proximal hamstring tendinopathy. A secondary aim of this study is to examine force steadiness in isometric contraction in a population with proximal hamstring tendinopathy compared to a matched population without the condition.

The aim of this project is to examine the influence of different anatomical structures on knee kinematics in total knee arthroplasty (TKA), with focus on condylar movement over the tibia (pivot and rollback through flexion). The study will examine the hypotheses that tibial internal rotation in balanced Kinematic Alignment (KA) Cruciate Retaining (CR) Computer Assisted Surgery (CAS) is synonymous with a medial pivot. Patients will be prospectively recruited to undergo KA CR CAS TKA. Values obtained from CAS intraoperatively will be validated using additional values measured using an Orthosensor, Versasense device.

We will conduct a multi-centred, double-blind randomised sham-controlled trial on 50 people with chronic SCI. The primary outcome will be walking ability measured using the Walking Index for SCI II (WISCI II). Participants will be randomised to either the Stimulation group or the Sham group. All participants will receive the same intensive locomotor training consisting of three one hour sessions per week, over 12 weeks, in combination with either stimulation or sham stimulation. The secondary outcomes will capture different aspects of recovery, strength, spasticity, and bowel function. Outcome measures will be taken at baseline, 12 weeks and 16 weeks after randomisation.

Impact Diabetes Bump2Baby is a study to test whether women at high risk of developing diabetes can reduce that risk through a healthy eating and physical activity smartphone app and tele-health coaching. Women presenting to the maternity service for the first time will be assessed, using a validated set of questions, to determine the likelihood that they will develop gestational diabetes during their pregnancy. Women identified as at high risk will be invited to take part in a study study, to see if a personalised tele-health coaching service can help women with the self-management of modifiable lifestyle risk factors compared to women who will receive usual care. The tele-health coaching is provided through a smartphone application (app) called “Bump2Baby & Me”. This will guide a woman through the journey from pregnancy to birth and the end of the baby’s first year. Trained health coaches will optimise engagement with the app and help to personalise the behaviour change experience. The app is supported by a developed and tested commercial platform, that uses a health coach dashboard to coordinate and tailor engagement for each woman. The platform will integrate seamlessly with a woman’s smartphone and each site will have their own dedicated health coach. Our study will involve a woman during pregnancy and after birth will include her baby. During the first antenatal visit, all women will be screened for their risk of developing gestational diabetes using standard information collected at this visit such as age, body mass index, family history of diabetes. Women scoring 3 or higher will be eligible to take part. At the start, we will take blood samples, measure weight and height and ask the woman to fill out some questionnaires. Women in the intervention group will have access to the Bump2Baby & Me app and tele-health coach during pregnancy and for the first 12 months after their baby is born. At 12 months we will ask women to come in for a follow-up visit where we will repeat the blood samples, body measurements and questionnaires. We will ask a random sub-sample to take part in a short exit interview.

Dose administration aids (DAAs) facilitate ease of administration by packaging multiple tablets together by date and time, thereby reducing unintentional non-adherence and medication errors. Use of reminder packaging has been shown to improve adherence by 11% measured by pill count. However, barriers to DAA use remain including cost, limited GP involvement in the initiation process, lack of patient understanding and lack of randomised controlled trials of DAAs in Australia. The PAX Pilot study will determine if a coordinated strategy of delivering cardiovascular drug therapy via dose administration aids can effectively increase prescription possession ratio compared to usual care. The study will test the hypothesis that the use of dose administration aids will increase adherence and therefore, increase prescription possession ratio, among people with greater than equal to 5 medications compared to usual care.

Almost half of women who become pregnant have overweight or obesity. As well as increasing the mother’s health risks, their babies have a higher risk of stillbirth, preterm birth, delivery complications due to larger size plus are more likely to develop childhood and adult obesity. Whilst trials to limit weight gain during pregnancy have had very limited success, there is increasing recognition that targeting obesity prior to pregnancy has greater potential to break the obesity cycle. Yet a recent Cochrane review of targeted pre-conception interventions in women with overweight or obesity found no eligible trials. If pre-conception weight loss in women with overweight or obesity were to be effective and translatable at scale, it would have enormous potential to improve the wellbeing of mothers as well as their babies in both the short and longer term. Aim: To evaluate the effectiveness of a translatable meal replacement diet program for women with overweight or obesity planning pregnancy on the incidence of significant perinatal outcomes compared with recommended advice. Design: A superiority, unblinded, multicenter RCT with two parallel groups and primary endpoint of combined perinatal adverse outcome. Population: Women (18-40 years) with overweight or obesity (BMI greater than 25kg/m2) planning a pregnancy within 6-12 months and intending to deliver at a recruiting centre. Methods: A pragmatic randomised controlled trial conducted across public maternity hospitals in New South Wales. We will recruit 1927 women with a BMI greater than 25 kg/m2. They will be randomised to: a) Nutritionally complete meal replacement diet program or b) recommended preconception advice on weight management, for a 10- week period with a 12 month follow up schedule. Outcomes Primary: gestational diabetes mellitus; pre-eclampsia; first Caesarean section, perinatal death; LGA (birth weight greater than 90th centile); admission to a neonatal unit. Secondary: Separate components of the composite outcome plus the following: Perinatal: Stillbirth (infant loss greater than 20 weeks of gestation), neonatal death, need for resuscitation at delivery, shoulder dystocia, nerve palsy, fracture, birthweight, breastfeeding at discharge Obstetric and Maternal: Gestational hypertension, assisted vaginal birth, spontaneous vaginal birth, post-partum haemorrhage, 3rd and 4th degree tears, length of stay in hospital,

Physical activity is recognised as an essential component of maintenance of respiratory health in cystic fibrosis (CF), and delivery of exercise education is a critical component of physiotherapy care. Reduced exercise capacity is associated with a decline in respiratory function and survival in people with CF. In both short and long-term studies, regular exercise has been demonstrated to decrease the annual decline in lung function in people with CF. Continued innovative approaches to prompt both exercise and activity participation and adherence at home for adults with cystic fibrosis is required. Group based exercise training is established as the gold standard in people with COPD resulting in reduced symptoms, improved quality of life outcomes, increased exercise capacity, reduced exacerbations and the prevention of hospital exacerbations. The current COVID-19 pandemic has already prompted a shift to ‘virtual’ models of care delivery within CF centres. People with CF are currently, and for the foreseeable future, receiving decreased routine face to face outpatient appointments at hospitals. This current change to care delivery minimises opportunities to offer exercise training for this cohort of patients. Home based tele-rehabilitation group exercise programs have been shown to improve exercise capacity in patients with COPD and other chronic diseases. A systematic review of telehealth in cystic fibrosis highlighted the potential to provide both physical activity and exercise programmes. Exercise sessions of 30 minutes, three times a week over six weeks offered via a virtual platform to children with CF demonstrated participation rates of 85%. The program was found to be a convenient and accessible method of encouraging physical activity and participants reported positive feedback regarding joining a group supervised class. Tomlenson et al ( 2019) examined the feasibility and acceptability of online exercise sessions using telehealth in nine adults with CF to engage patients in individualised exercise programs 2 -3 times a week 20. The participants successfully participated in the classes, rating satisfaction with the virtual training at 9/10, while compliance with sessions was 68%. Whilst these studies suggest that online training is feasible, questions remain regarding the applicability of the outcomes to the cohort of patients provided with care by TPCH Adult Cystic Fibrosis centre (ACFC). The large number of patients receiving care by this centre (over 300) is prohibitive to offering all patients individualised exercise classes. Delivery of 1-on-1 exercise training is labour intensive and expensive. Rapid improvements in survival of people with CF is expected to result in increased demand on physiotherapy services, which will outstrip service capacity. Consequently, alternate, scalable models of delivering exercise training are required.