ANZCTR search results

The purpose of this project is to design and pilot an advanced train-the-trainer course for Occupational Therapists, Physiotherapists and Rehab Assistants (clinicians) to strengthen their skills to coach people with neurological conditions to independently use the SMART Arm to drive their own arm recovery. A sequential mixed methods design will be utilised with a sample of 40 people with a neurological condition and 10 clinicians working at CRnQ. Phase I of the study will involve development and administration of a quantitative survey questionnaire to determine requirements for SMART Arm Advanced Training. Established SMART Arm clinical guidelines and recent findings in the scientific literature will be utilised for this purpose. The newly developed survey will be administered with participating clinicians and people with neurological conditions who have respectively delivered, or participated in, SMART Arm training at CRnQ. In order to verify and interpret survey findings, two focus groups will be conducted, one with clinicians and one with a selection of people with neurological conditions, all of whom will have participated in the survey. Focus groups will be audiotaped and transcribed verbatim and content analysis of the data undertaken. Phase II of the study will involve development and piloting of the SMART Arm Advanced Train-the Trainer Course materials and corresponding Capability Assessment Tool and will be based on Phase I outcomes. All participating clinicians will undertake the new Train-the-Trainer Course and complete the Capability Assessment Tool, with respect to their own capability. Group feedback on collated results will be provided to clinicians promptly and advice provided on areas for improvement. Three months and six months later, clinicians will complete the Capability Assessment Tool again. In addition, those individuals with a neurological condition that have participated in SMART Arm training during the period following delivery of the Advanced Training course will complete the Capability Assessment (with respect to clinicians capability) at the three month and six month time period. At each timepoint, group feedback on collated results will be provided to clinicians and advice given to address areas for improvement.

Neck pain is highly prevalent and a leading cause of disability worldwide. Manual therapies are commonly used to treat neck pain, and there is some evidence of the effectiveness of mobilisation and manipulation for neck pain. When compared with each other, mobilisation and manipulation have been shown to have similar effects. In light of the potential serious adverse events associated with manipulation, the Cochrane Back and Neck Group have highlighted further investigation of mobilisation as a research priority. Additionally, with little information available about which are the most effective techniques and approaches to mobilisation, the Cochrane Group has recommended future research also focus on addressing this question. There are currently two distinctly different approaches to cervical spine mobilisation for people with neck pain. A pragmatic approach is based on the assumption that individualised treatments, with key dosage parameters determined by careful assessment of pain and movement are important determinants of outcome. A prescriptive approach is based on the assumption that standardised techniques and dose are effective, and that patient selection is the main determinant of outcome. This pilot study will investigate the feasibility of a trial to determine whether a pragmatic or a prescriptive approach to cervical spine mobilisation more effective in relieving pain and restoring function in people with recent onset neck pain

The primary purpose of this trial is to evaluate the safety and efficacy of venetoclax in combination with chemotherapy for the treatment of acute myeloid leukaemia (AML) in elderly patients. Who is it for? You may be eligible to participate in this trial if you are aged 60 or over with monosomal karyotype, or aged 65 or over with any karyotype, and have been diagnosed with AML for which you have received no induction chemotherapy. Study details All participants enrolled in this trial will be administered Venetoclax in combination with modified-dose chemotherapy. The dose provided will depend on the time of enrolment - each sequentially enrolled group of participants will be administered with a slightly higher dose than the previous group, pending a review of the safety of the previous dose. Participants will have an induction treatment consisting of 14 days Venetoclax tablets, 5 days IV Cytarabine and 2 days IV Idarubicin. For participant achieving a response to treatment there will be up to 4 further cycles of 14 days Venetoclax, 2 days Cytarabine and 1 day Idarubicin or until adequate blood count recovery. Participants will be assessed through blood samples taken daily during initial hospitalisation and then at the end of each cycle of treatment, bone marrow samples taken 3 times during induction and then every other cycle as well as a physical exam every cycle in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the AML. It is hoped that the findings of this trial will provide information on the optimal dose of Venetoclax in combination with chemotherapy for the safe and effective treatment of AML in elderly patients.

Exercise training is commonly used for the treatment and prevention of many chronic diseases. Of particular interest are the effects of exercise training to prevent many age-related changes, including reduction in blood vessel health and whole body fitness. Healthy older adults will be recruited to participate in an 8 week exercise training program where they will be randomised to one of three different cycle training groups: moderate intensity double-leg continuous cycling, high intensity double-leg interval cycling, or high intensity single-leg interval cycling. Measures of blood vessel function, heart structure and function, fitness and body composition will be obtained at baseline, 4 weeks (blood sample and vessel function only), 9 weeks and 16 weeks.

The purpose of this project is to investigate whether the use of a rapid form of transcranial magnetic stimulation (TMS), called Theta Burst Stimulation (TBS), is a successful treatment for patients with treatment resistant depression compared to the standard form of TMS that has been used to date. TMS involves the application of magnetic stimulation to your head and, given repeatedly over time this stimulation has been shown to change the activity levels in the brain. Previous experience has shown that people with depression may have an imbalance in the excitability, or ‘activity levels’, of cells in the brain. TMS appears to work by changing how excitable the cells of the brain are, which may help reduce or alleviate depressive symptoms. We are conducting this study to see if we can speed up the response to TMS using a rapid form of TMS called Theta Burst Stimulation (TBS). Theta burst stimulation (TBS) is a type of TMS where the magnetic pulses are applied in very short bursts (three pulses at a time) at a high frequency (30-50 pulses a second).

The goal of this study is to evaluate whether number and intracellular protein content of stem/progenitor cells (SPCs) in diabetic patients with lower extremity neuropathic wounds (diabetic foot ulcer or DFU) are correlated with wound healing and with diabetes-related factors. The hypothesis is that SPCs-specific variables can be used to predict diabetic wound healing. This study was designed based on results from a recent preliminary clinical trial

Metacarpal neck fractures represent the most common hand injury, with 5th metacarpal fractures accounting for the majority . Known as Boxer’s Fractures, these injuries are commonly the result of a closed fist strike, and are seen more frequently in young males, often associated with an aggressive strike, or a fall onto a fist during sporting activities. Traditionally, 5th metacarpal neck fractures have been managed with closed reduction and cast immobilisation and followed up in an orthopaedic clinic. However, due to the nature of the injury and then anatomy of the hand musculature, closed reduction often has little benefit in reducing the fracture and improving angulation. Moreover, it has been shown that there is no functional deficit in healed fractures with up to 70 degrees of angulation, provided there is no rotational deformity of the fracture fragments . Several orthopaedic and emergency departments now manage minimally-rotated Boxer’s Fractures with buddy strapping alone, thus encouraging mobilisation and an immediate return to work and activities. Currently, there is no consensus as to the best management of 5th metacarpal neck fractures. A previous Cochrane review found insufficient evidence to recommend a particular management course, but reported no adverse outcomes from simple buddy strapping. More recently, a study comparing closed reduction and plaster, with buddy strapping and soft wrap, suggested no adverse outcome to strapping, and a significant improvement on time to return to work for the buddy strapping group. The patient demographic associated with Boxer’s Fractures (young, male, working) historically have a suboptimal compliance with follow up. In one study, 10% of patients removed splints themselves and never returned to follow up. If these injuries can be managed with minimal intervention and community follow up, time would be saved in both the emergency department and orthopaedic outpatients, with a concurrent economic benefit. We propose a prospective, randomised study to assess outcomes of 5th metacarpal neck fractures (Boxer’s Fracture). The proposed study will compare minimal intervention (buddy strapping of ring and little fingers) with current practice; plaster cast in position of safe immobilisation (POSI). This study aims to provide an answer to the question regarding the best management of these fractures.

The primary purpose of this pilot trial is to examine the efficacy of decitabine in combination with carboplatin for the treatment of metastatic melanoma. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, and have been diagnosed with metastatic melanoma which has been resistant to all previous treatments. Study details All participants enrolled in this trial will receive combination therapy with two chemotherapy agents, decitabine and carboplatin, according to the following treatment regime. On days 1-5, patients will receive a daily intravenous infusion of decitabine, followed by a single infusion of carboplatin on day 8. There will then be no treatment administered for the remainder of the cycle, until the regime is repeated starting on day 29. Researchers will perform tests on blood and tumour biopsy samples to examine the efficacy of the treatment in altering tumour cells so that they are more vulnerable to the immune system, and thus treating the cancer. It is hoped that information from this trial will provide preliminary information on the efficacy of decitabine in combination with carboplatin for the treatment of metastatic melanoma, and provide data to inform a larger clinical trial of this therapy.

This project aims to substantiate the effects of acute ingestion of high pinitol carob fibre on glycaemic control and subjective satiety and appetite responses. A secondary aim is to distinguish any additional clinically relevent effects of the pinitol compared to the fibre alone. We hypothesise that high pinitol carob fibre within a cereal-based test food will lower glycaemic and insulinaemic responses and increase satiety resulting in lower dietary intake.

Small and premature babies often need help to breathe after birth, sometimes for many weeks. Established methods of providing breathing support are Continuous Positive Airway Pressure (CPAP) and Nasal Intermittent Positive Pressure Ventilation (NIPPV). CPAP and NIPPV use warmed air and oxygen given into the baby’s nose using small soft plastic prongs. This is very effective, but sometimes the plastic prongs can cause the skin in and around the nose to become sore or damaged. Skin damage is particularly common during CPAP /NIPPV treatment in very preterm and tiny babies. The aim of the ProNose study is to see whether using a barrier dressing over the nose can reduce damage to the nose in very small babies receiving CPAP/NIPPV. To work out whether the barrier makes a difference, we organise babies receiving CPAP/NIPPV into two groups one group will have the barrier dressing and the other will not. The group results are then compared to see if there is any difference in the number of babies who get a sore nose. Babies can join this study if they are born before 30 weeks' gestation or weigh less than 1250 grams at birth, and need CPAP/NIPPV treatment. Some babies will need this from soon after birth; other babies will need support from a ventilator (breathing machine) to begin with, and become ready for CPAP/NIPPV later on. When a baby is ready to start CPAP/NIPPV, or soon after they have started this, babies will be randomly placed in one of the two study groups: (1) using the barrier dressing (BARRIER group) or (2) normal care – without the barrier dressing (NO BARRIER group). Babies in the BARRIER group will have the barrier dressing applied within the hour, and will continue to have the barrier dressing whenever they are receiving CPAP/NIPPV for at least 2 weeks, or until they are 30 weeks from the start of pregnancy and weigh more than 1250 grams, unless they stop CPAP/NIPPV before then. The barrier dressing material will be replaced when required, as assessed by the clinical teams. Babies in both groups will be followed for the study throughout their time at the Women’s. We will also take regular photographs of babies' noses whilst they are in this study and on breathing support. This is so that we can objectively assess whether there is any injury to the nose. The ProNose study will enroll 206 babies at the Women’s and will take about 18 months to complete.