ANZCTR search results

This research study aims to look at the effects of combining music therapy with functional electrical stimulation on arm and hand function after stroke. Functional electrical stimulation (FES) is an evidence-based therapy that is widely used in stroke rehabilitation of the arm and hand. Music therapy allows people to engage in music-based exercises, such as playing an instrument, as part of their rehabilitation and therapy. In iPad-based music therapy, the instrument that is used is in the form of an iPad application. In this project, we will use “ThumbJam”; a touch-sensitive iOS application in which instrumental sounds and scales (combinations of notes) can be programmed according to the preference of the user. This study will examine the effect of combining FES and iPad-based music therapy (“FES+iPad-based music therapy”) as an addition to usual treatment, in comparison to usual treatment alone. It is important to note that FES may or may not already be part of usual treatment. The primary aim of this research is to examine whether the addition of FES+iPad-based music therapy will further improve the functional activity of the affected arm and hand of stroke survivors. The secondary aim of this research is to examine the effect of the addition FES+iPad-based music therapy on wellbeing outcomes such as self-efficacy, depression, anxiety and stress, in comparison to usual treatment.

This project aims to determine whether infusing virus specific T cells from normal donors and frozen in liquid nitrogen is safe and effective therapy in patients at the first sign of virus infection after blood or bone marrow transplant. During the project a bank of frozen virus specific T cells will be created and if a blood or marrow transplant patient develops a virus infection that needs treatment, cells from the bank will be used early during the infection to see if they can recreate immunity to the infection and avoid the necessity for prolonged used of toxic antiviral drugs.

Osteoarthritis (OA) is degenerative disease effecting joints and is characterized by articular cartilage remodeling. It is one of the most common musculoskeletal disorders worldwide and affects an estimated 15% of Australians (3 million people) (Glyn-Jones et al., 2015). OA causes pain and eventual disability, and while not usually considered an inflammatory condition, there is associated inflammation of synovial tissue (Benito et al., 2005). The complex nature of the symbiotic relationship between the gastrointestinal microflora or microbiome and the health of the host has been elucidated in recent years. An unbalanced microbiome, dominated by certain species increases the risk of diverse systemic diseases, and inflammation, often low grade and chronic, is a common factor in many of these conditions. Evidence from animal and human trials suggest probiotics may be able to positively impact bone metabolism, reduce inflammation and pain attenuating inflammation via improving muscosal barrier health (Collins et al, 2015, Lei et al., 2014)) (Lei, 2014). The project aims to assess whether a three week course of probiotics is effective for reducing the pain associated with osteoarthritis in two participants diagnosed with osteoarthritis.This is an N-of-1 series, consisting of two double-blind placebo-controlled N-of-1 trials in otherwise healthy individuals. Each trial incorporates 3 randomised blocks, each consisting of 2 X 3-week period, which may comprise either the active or placebo supplement, designated A or B . Between each period there is a 2-week washout period. The primary outcome is self-reported pain, as measured by a 100mm Visual Analogue Scale. Secondary outcomes include the Patient Specific Functional Scale (PSFS) which consists of up to five self-nominated items that the participant perceives to most interfere with their daily functioning. The participant rates each item on a numerical scale 0 to 10 where 0 represents “no difficulties” and 10 represents “can’t do it at all”. This scale will be completed at the beginning and end of each 3-week intervention period. Usage of the preferred rescue medication (paracetamol) will be monitored throughout the 30-week duration of the study. The 2005-Complete Digestive Stool Analysis (CDSA) kit will be used to monitor the probiotic concentration on four occasions (Weeks 2, 5, 7 and 10).

Serum/plasma (blood) is routinely used for measurement of albumin/creatinine in the critically ill. However, point-of-care (POC) urinary albumin/creatinine testing in patients admitted to the Intensive Care Unit (ICU) may be advantageous due to the rapid availability of results. To date, the accuracy of POC urinary albumin/creatinine compared to laboratory analysis in this population has not been evaluated. The anticipated outcome of this project is that if agreement is detected between POC and laboratory analysis, then POC testing may be a valuable methodology for measuring urinary albumin/creatinine in critically ill patients. This could have useful applicability for rapid assessment of results, therefore predicting prognosis and mortality in this population.

To support healthy ageing, interventions to improve the nutritional status of older adults and the integration of formal and family care systems are critical research areas of the United Nations 21st Century Research Agenda (items 2.6.10 and 2.10.7). Our observational pilot research identified that one in two older Australians admitted to rehabilitation in Murwillumbah were malnourished, and that they remained malnourished throughout their admission and for at least 12-weeks in their own homes following discharge. Compared with well-nourished patients, malnourished patients were more likely to be admitted to residential aged care and be rehospitalised. Supported by feasibility studies which utilised the “theoretical domains framework”, the proposed pilot intervention project evaluates efficacy of the FREER (Family in Rehabilitation: EmpowERing carers for improved nutrition outcomes) intervention: a low-cost model of care for malnourished older rehabilitation patients which harnesses the under-utilised expertise/skills of family carers to synergise with the existing nutrition workforce support. Through providing malnutrition counselling in rehabilitation, telehealth follow-up and supportive resources after discharge, FREER aims to cost-effectively empower family carers to improve patient and carer health-related outcomes. Using a historically controlled, two-arm intervention trial design, the FREER Pilot Study aims to determine: In n=30 malnourished older rehabilitation patients and their adult family carers, does the FREER intervention, compared with usual care, improve a) patient nutritional status, b) physical function, c) quality of life, d) service satisfaction, e) hospital and aged care admission rates during rehabilitation admission and up to 3-months post-discharge? As a pilot study, this project also aims to evaluate the feasibility and intervention fidelity to inform a larger RCT. The intervention group will be compared with n=30 historical control participants with the same eligibility criteria collected from Ballina and Murwillumbah rehabilitation units from 2013-2014.

A new type of procedure for managing obesity has recently become available in Australia: Endoscopic Sleeve Gastroplasty (ESG), which stimulates weight loss by reducing gastric volume. Unlike the widely implemented laparoscopic sleeve gastrectomy (LSG), the less invasive and incisionless ESG is performed endoscopically and trans-orally. Therefore, the ESG will reduce surgery-related complications and recovery time. Therefore, a non-inferiority prospective cohort study will be undertaken to determine the weight loss efficacy, safety, and effect on comorbidity risk factors and quality of life of obese adults receiving Endoscopic Sleeve Gastroplasty (ESG) compared with Laparoscopic Sleeve Gastrectomy (LSG). 106 participants will be consecutively recruited from Weight Loss Solutions Australia on the Gold Coast. The primary outcome will be excess weight loss at 6-months post-procedure, and secondary outcomes will examine body composition (via DXA), quality of life, complications related to the procedure, lipid profile, blood pressure, comorbidities, blood pressure, and allied health use.

Pancreatic cancer cells have DNA mutations that are not present in normal cells. For some people, cancer-specific DNA can be found circulating in their bloodstream after they had surgery to remove their pancreatic cancer. This tumour-specific DNA may be evidence that some cancer cells have escaped before the pancreatic cancer was removed. The DYNAMIC-Pancreas study aims to see whether a test called “circulating tumour DNA” can be used to decide the type and duration of post-surgery chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have undergone curative surgery for localised pancreatic cancer and have been recommended adjuvant chemotherapy. You will still be eligible if you had neoadjuvant treatment prior to surgery. Study Details. All participants in this study will have blood drawn for circulating tumour DNA analysis during week 4-6 post-surgery, and throughout chemotherapy treatment (up to 3 times). Participants that had neoadjuvant therapy prior to surgery, will be randomly allocated to one of two treatment groups, where the choice of chemotherapy regimen will be made prior to randomisation: One group will receive the standard of care treatment of modified FOLFIRINOX – a combination of fluorouracil (5-FU), leucovorin, irinotecan and oxaliplatin. The other group will have their treatment based on their circulating tumour DNA blood test results. Patients with a positive test will be offered an alternative chemotherapy than the standard treatment. Patients with a negative test will be offered a shorter duration of the standard treatment. Participants that did not have neoadjuvant therapy prior to surgery, will be placed in a separate, non-randomised group. All participants in this group will have their treatment selection based on their circulating tumour DNA blood test results. Patients with a positive test will be offered an alternative chemotherapy than the standard treatment or a longer duration of the standard treatment. Patients with a negative test will be offered a shorter duration of the standard treatment. All patients will be followed up every 3 months for 2 years, then every 6 months up to year 5. Follow up includes blood tests and radiological assessments. It is hoped that this study will provide evidence that using a test to look for the presence or absence of circulating tumour DNA can help guide the type or duration of adjuvant chemotherapy used after pancreatic cancer surgery.. This test may reduce the number of patients that have detectable circulating tumour DNA after completing adjuvant chemotherapy, compared to standard of care treatment. This may in turn demonstrate that management of pancreatic cancer based on circulating tumour DNA results is superior to the current standard of care treatment.

The aim of the study is to determine whether falls, pain catastrophising, anxiety and depression are associated with poorer post-operative outcomes including falls risk, number of falls, physical function, functional mobility, length of stay, and the need for extra rehabilitation services in patients undergoing total joint replacement. Key research questions are: Does falls risk, anxiety and depression preoperatively predict post operative poor outcomes following joint replacement surgery? Do psychological and physical components have an association in the prediction of falls in the preoperative and post operative periods in the patients having total joint replacement?

The current project aims to: " Use principles of Implementation Science to promote uptake of, and confidence in using the Unified Protocol for Adolescents (UP-A) by CYMHS clinicians with anxious and/or depressed adolescents in the real world setting of a CYMHS community clinic. " Evaluate the UP-A compared to treatment as usual (TAU). It is hypothesised that by the end of the proposed project: " The confidence of CYMHS clinicians in the utility and delivery of the UP-A with anxious and/or depressed adolescents will have increased following a sequence of targeted implementation processes to support uptake of the EBT in community Clinic A; and " The UP-A will produce superior outcomes on measures of adolescent anxiety and depressive symptomatology compared to TAU.

Severe early-onset intrahepatic cholestasis of pregnancy (ICP), a recognised rare disease of pregnancy, is associated with increased rates of stillbirth, preterm birth and neonatal morbidity. The optimal treatment and management of women who are diagnosed with this condition are not known. We plan to compare a standard treatment used for cholestatic itch outside pregnancy (rifampicin) with a standard treatment of ICP (ursodeoxycholic acid - UDCA) to determine comparative safety and efficacy.