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GotRhythm: A tailored music therapy and real-time biofeedback mobile phone app to promote rehabilitation following stroke
This pilot study aims to investigate the effect of a novel mobile phone based music-motor therapy software application (app) on human motor control. There is considerable interest in using music therapy combined with movement as a way to change the brain and improve functional recovery following injury to the central nervous system. To date, current therapies incorporating movement and rhythmic cues (metronome or music) are effective at improving upper extremity motor control and gait in neurological disorders, including Parkinson’s Disease, Stroke, and Traumatic Brain Injury (TBI). However, these therapies have a number of limitations, including lack of feedback about motor responses in relation to the music, and lack of portability. We have developed a novel mobile software application – GotRhythm – that uses mobiles and wireless wearable sensors to deliver music-motor therapy to patients with real time biofeedback. The proposed study will investigate the effectiveness of this new music-motor therapy app at improving motor control in patients following neurotrauma and and allow us to optimise future treatments for neurotrauma patients.
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Theta Burst Stimulation in fibromyalgia
The proposed study aims to conduct a double-blind, randomized, sham-controlled proof of principle trial to establish the efficacy of Theta Burst Stimulation (TBS) treatment in fibromyalgia. Fibromyalgia and related disorders present a substantial health problem, with current treatments limited in their efficacy and associated with a number of side effects. This study will explore for the first time in fibromyalgia a novel non-pharmaceutical intervention, TBS; a non-invasive brain stimulation method. TBS is a powerful new alternative to standard non-invasive brain stimulation methods as it can be applied in a much more time efficient manner and may result in greater clinical benefit. If successful, the application of this method for fibromyalgia may be applicable to related disorders such as Chronic Fatigue Syndrome. This is a randomised sham-controlled trial study, in which 52 participants with a diagnosis of fibromyalgia will be recruited. Participants will be randomised into one of two conditions- (1) Active TBS condition and (2) Sham (or ‘placebo’) TBS condition. Participants will have two weeks of twice daily stimulation followed by a tapered two week dose of twice daily treatments on Monday, Wednesday and Friday only. Participants will be asked to a number of self-report questionnaires at baseline, at the end of each treatment week (weeks 1-4) and at the 1 month follow up appointment, as well as will undergo the collection of neurobiological data (TMS-EEG) at baseline, end of week 4 and follow-up.
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The Effect of Applied Muscle Tension On Vasovagal Reactions Study
A common complication in whole blood donation is a vasovagal reaction (VVR), being 90% of all incidence reports. A VVR causes a donor to feel light-headed, dizzy or faint during or after their donation. These reactions can be triggered by pain or emotions (e.g., fear of needles), or when standing up too quickly after donation. These reactions have a negative impact on donation satisfaction, donor safety and wellbeing, and donor return rates. VVRs pose a particularly high risk to first-time donors, those aged less than 30 years, females, individuals with a low body weight, and donors who report high pre-donation anxiety. In 2016 in Australia, 58% of whole blood donors did not return to donate within six months following a phlebotomist-registered reaction compared to 35% who had an uncomplicated first donation. Therefore, reducing risks to donors is inherently important. A technique which has received increasing support in reducing the rate of VVRs is applied muscle tension (AMT). AMT has been indicated to benefit the donor both physiologically, through an immediate increase in blood pressure, and psychologically, through distraction and anxiety reduction. At the Australian Red Cross Blood Service, AMT is currently included in the standard operating procedures to treat VVR but international studies have demonstrated the potential of utilising the technique as a prevention method. Practicing AMT during the entire donation procedure results in significantly fewer self-reported VVRs, increased completed donations, less chair reclining, reduced feelings of anxiety and greater intentions to return. However, these studies have reported low adherence to the technique among donors: only 22% of study participants reported using AMT throughout their donation. Despite growing evidence of the efficacy of AMT in reducing VVR, no research has examined how AMT can be successfully implemented into the routine blood donation procedure and maximise donor adherence. Consequently, the impact of AMT in day to day practice has not been examined and its potential to increase donor retention and contribute to the maintenance of a stable blood supply has yet to be fully realised. The overall aim of this project is to examine the effectiveness of AMT within Australian donor centres in a randomised controlled trial.
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A randomised trial to evaluate the effect of an education program on the physical activity of University female staff aged 50 years and over
This randomised waiting list controlled trial aims to test the impact of an intervention designed to enhance ongoing physical activity participation in women aged over 50. 100 female University staff aged 50 years and older will be recruited via University newsletters and websites. Exclusion criteria are limited English skills, a medical condition precluding participation in regular exercise, or currently meeting physical activity guidelines. Upon giving informed consent participants will complete a baseline survey on physical activity knowledge, attitudes and behaviour, physical functioning and mood. Current physical activity level will be measured with an accelerometer, worn on the hip for 7 consecutive days to determine the average daily step count. Participants will then be randomised to attend a workshop immediately, or after 3 months. At 3 months post randomisation, similar surveys and wearing the accelerometer will be repeated. The intervention will be a one-hour workshop to give information about the importance of physical activity for maximising physical and mental health and preventing disability in women, and to provide information about existing opportunities to participate in and enhance physical activity. An email list and on-line discussion group will be set up for those wishing to remain in contact. Workshop materials will be made freely available at the completion of the project, and participants will also be offered the use of a pedometer or internet-connected activity tracker (Fitbit) for the duration of the study, to provide motivation and feedback to increase activity levels. Participants randomised to the control group will be allocated to a waiting list and receive access to the intervention after the 3-month follow-up period. The primary outcome will be the proportion of people achieving an average of at least 10,000 daily steps, measured with an accelerometer. The secondary outcomes will be the proportion of people achieving adequate physical activity levels as recommended by national physical activity guidelines, average total number of hours of physical activity per week, change in perceived benefits of and barriers to exercise participation, physical functioning, mood. Analyses will be pre-planned, conducted while masked to group allocation and will use an intention-to-treat approach. 50 participants per group (i.e. 100 participants) will provide 80% power to detect 30% more people in the intervention group reaching the recommended 10,000 steps/day than the control group. This calculation assumed a proportion of 27% compliance with the 10,000 steps/day activity level in the control group, 15% dropout rate and 5% alpha. This sample size is also expected to be sufficient to detect between-group differences in the order of 10-15% for the secondary outcome measures. If shown to be effective, this study is an approach that could be implemented more broadly to increase the population health impact.
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A Safe Transfer Program to Improve Gait and Reduce Falls in Cognitively Impaired Older Adults with Higher Level Gait Disorders: A Pilot Study
This research project will investigate the feasibility and acceptability of combined Errorless Learning (EL) and Spaced Retrieval (SR) techniques in a safe transfer program to improve gait and prevent falls in adults aged 65 and over with mild to moderate cognitive impairment and higher level gait disorders. The assessments and intervention will be conducted at participants' home by a senior occupational therapist who is a co-investigator of the study. The 3 week intervention program starts with more intensive therapy in week 1 (4 sessions, 30min each session) and gradually decreases the intensity in week 2 (2 sessions, 30min each session) and week 3 (1 session, 30min each session). Following demonstration of the transferring task by the therapist, participants are provided with verbal cues prior to each step when performing the task (EL) and the time intervals between each session gradually increase (SR). The transfer training practice will be generalised into real life activities in week 2 and week 3 of the program. Follow up assessments at 3 months post intervention will also be conducted at the participants home. This project will form the pilot study for a larger multi-centre clinical trial, which will assess the long-term effect of this novel falls prevention program targeting older adults with cognitive impairment and higher level gait disorders.
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Improving Glucose Outcomes Using a Novel Treatment Strategy in Young Adult Onset Type 2 Diabetes
Guidelines for the treatment of type 2 diabetes direct clinicians to individualise therapy in diabetes however there is little evidence to guide successful treatment in Young Adults with Type 2 Diabetes (YT2DM). This study will provide much needed evidence on which to base treatment decisions for YT2DM, a growing problem in our clinics. The outcomes of a physiologically sensible, innovative continuous glucose monitoring-guided rapid titration strategy which differs from usual care will provide new knowledge on the treatment for this high risk group. Further the fundamental physiologic effects of this strategy on beta cell function and early renal decline in YT2DM will provide further insights to guide therapeutic decisions for this high risk patient group. If positive, the results can be translated into wider practice and guide individualised therapy in addition to evidence based clinical practice guidelines for YT2DM. The global nature of the problem of YT2DM will ensure international interest and the investigators are well placed to facilitate dissemination of results to wider stakeholders and translation.
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Comparison of Thresholds for Phototherapy in Newborns <32 weeks gestational age
The purpose of the study is to determine whether higher threshold for commencing phototherapy will worsen the rate of rise in bilirubin in the first 72 hours of life in newborns born <32 weeks gestational age. We hypothesise that the higher threshold for phototherapy will result in similar trends in bilirubin levels, duration of phototherapy and number of infants reaching bilirubin levels <25umol/L below exchange threshold in both groups.
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Effects of high-intensity interval training on glycaemic control in adults with type 1 diabetes
Background Blood glucose control is fundamental to the management of type 1 diabetes (T1D) to reduce rates of diabetes complications. Exercise studies have not been able to show a consistent benefit on blood glucose control in people with T1D. High-intensity interval training has been found to improve long term blood glucose control (HbA1c level) in people with type 2 diabetes. To our knowledge, there are no adequately-powered studies looking at the effect of HIIT exercise on HbA1c in people with T1D. Research Question In adults with type 1 diabetes who are overweight or obese, will 12-weeks of high-intensity interval training improve blood glucose control (HbA1c), cardiovascular risk factors and diabetes complications? Study aim This study will potentially show the first evidence that HIIT exercise can improve HbA1c without excess risk of hypoglycaemia (low glucose) in adults with T1D. Also, such exercise intervention may improve cardiovascular risk factors, and some aspects of traditional and novel diabetes complications including measures of non-alcoholic fatty liver disease, diabetic cardiomyopathy and cardiac autonomic neuropathy. Research design and methods In a randomised controlled trial (study period 1; 12 weeks) with subsequent partial cross-over (study period 2; 12 weeks), 30 sedentary adults with T1D who are overweight or obese will be randomised to the intervention group (12 weeks of supervised high-intensity interval training (HIIT) exercise, and then 12 weeks of unsupervised exercise) or the control group (12 weeks of usual care, and then 12 weeks of supervised HIIT exercise). The primary outcome will be HbA1c blood test at the end of the randomised controlled trial period (12 weeks exercise vs usual care), with a secondary outcome being to compare HbA1c with all 30 participants’ own baseline. The partial cross-over design allows all participants to benefit from undertaking the supervised HIIT, and has the advantage of increasing statistical power to secondary outcome measures. Further secondary outcomes include measurement of hypoglycaemia, hyperglycaemia and glucose variability using a glucose sensor, cardiorespiratory fitness using a treadmill fitness test, and cardiovascular risk factors such as blood pressure, cholesterol levels, weight, and body composition with a DEXA scan. Several diabetic complications will be examined for improvements after exercise, including diabetic cardiomyopathy and non-alcoholic fatty liver disease with cardiac and liver MRI, and cardiac autonomic neuropathy with bedside electrocardiography (ECG) testing. Importantly, changes in quality of life and fear of hypoglycaemia will be measured with validated diabetes-specific questionnaires.
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A phase I, placebo controlled, dose escalation safety and pharmacokinetic study of (Z)-Endoxifen in healthy female volunteers.
This study aims to evaluate the safety and pharmacokinetic study of (Z)-Endoxifen escalated doses in healthy female volunteers. Who is it for? You may be eligible to join this study if you are a healthy female aged between 18 and 65 years of age. Study details: This is a placebo controlled, dose escalation study. The study will be conducted in two parts in a total of 6 cohorts. In Part A, each participant will receive twenty eight doses of (Z)-Endoxifen or placebo as a topical application to the breast. In Part B, participants will receive fifteen doses of (Z)-Endoxifen or placebo capsules orally. Three different dose levels of (Z)-Endoxifen will be investigated in each part of the study. In both parts, sequential cohorts will be exposed to increasing doses of (Z)-Endoxifen. By substituting Tamoxifen treatment with Endoxifen the study will help in providing an improved approach towards treating patients with breast cancer because it bypasses the CYP2D6 enzyme that is required for metabolic activation of Tamoxifen.
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Skin Preparation for Surgical-Site Antisepsis in Gynaecological Laparoscopic Surgeries: A Double Blinded Randomised Controlled Trial.
Surgical Site Infections (SSI), including infections of the skin, subcutaneous tissue and internal organs, are one of the most common serious complications of surgery and anaesthesia. They are a leading cause of re-admissions and prolonged hospitalisations and they substantially increase the cost of care. Rates of SSI for individual procedures vary widely depending on the population, size of the hospital, type of surgery, experience of the surgeon and methods used for prevention and surveillance. Overall, it is estimated that SSI develops in up to 15 percent of patients undergoing surgical procedures. Endoscopic gynaecologic surgery is a rapidly developing field. Laparoscopic surgery is nowadays used for many procedures that were traditionally performed via laparotomy. Up to date, there are no prospective studies that specifically evaluated the rates of SSI in laparoscopic gynaecologic surgeries or the preferred way of skin preparation to prevent them. Gynaecology units 1 and 2 of The Royal Women's Hospital perform over 700 laparoscopies annually. All patients who undergo planned surgery present to clinic before surgery. We aim to perform a Randomised Controlled Double Blinded Study comparing 3 solutions of skin preparation containing alcohol or aqueous based Povidone-Iodine or Chlorhexidine. Our hypothesis is that Incisional and organ/space SSI rates would be similar throughout all groups. Patients would be followed-up one and four weeks after surgery and SSI rates would be compared amongst groups. SSI would be documented and defined as per the CDC guidelines. We are aiming to examine if we rates of surgical site infections can be reduced by using a specific solution for skin preparation.