ANZCTR search results

This randomised control trial will aim to explore the effectiveness of pre-formed, semi-rigid, customised foot orthoses (FOs) in reducing pain; improving quality of life; reducing swelling and tenderness; and improving gait parameters in children suffering from active lower limb involvement in juvenile idiopathic arthritis (JIA). Hypotheses: Primary Outcomes 1. Pre-formed FOs will reduce lower limb pain using visual analogue scale (VAS) in children with JIA Secondary Outcomes 1. Pre-formed FOs will improve quality of life in children with JIA using the Pediatric Quality of Life Questionnaire™ (PedsQL) Rheumatology Module – version 3.0 for children and parents. 2. Pre-formed FOs will improve foot disability in children with JIA using the Juvenile Arthritis Foot Disability Index (JAFI). 3. Pre-formed FOs will reduce localised swelling and tenderness of lower limb joints in children with JIA by visual inspection and palpation. 4. Pre-formed FOs will have an effect on quantitative kinematic and kinetic parameters of gait in children with JIA when barefoot, with shoes alone, and with shoes and FOs. Participant's who are eligible and consent to partake in the research based on the study's inclusion and exclusion criteria will be randomised into two groups. Thirty-three participants will be allocated to the trial intervention group, and the remaining thirty-three will be allocated to the control group. The trial group will receive a pre-formed, semi-rigid, customised foot orthoses, while the control group will receive a placebo device made from basic materials. The control orthoses will be made to resemble standard innersoles in athletic-style footwear. To help prevent participant's on knowing their allocated interventions, the top covers of both the trial and control groups will be made from the same materials. The participant's will be required to wear their allocated interventions for a maximum of 12 months. Primary outcome will be assessed at baseline,4-weeks, 3,6 and 12 months, Quality of life and foot disability will be assessed at baseline, 3,6 and 12 months. Joint swelling and tenderness, and gait parameters will be assessed at baseline, 3 and 6 months. Please note that one previous study was done with a similar methodological approach.(which was given a Clinical Trial ID with Clinicaltrials.gov: NCT02001844) [1]. This particular randomised control trial is unique to this previous study as it will investigate the effectiveness of foot orthoses in the treatment of swollen and tender lower limb joints. It will also be the first study to investigate any type of foot orthoses beyond 6 months in children with JIA. 1. Coda A, Fowlie PW, Davidson JE, Walsh J, Carline T, Santos D. Foot orthoses in children with juvenile idiopathic arthritis: a randomised controlled trial.

The Maxm Skate is a portable lower limb post-operative and post-injury rehabilitation exercise device for individual use in a hospital or home-based setting. It allows the patient to perform strengthening exercises with minimal joint loading during their rehabilitation period. The primary objective of this randomised controlled study is to assess the range of motion (ROM) achieved by patients whom received the Maxm Skate rehabilitation device compared with standard rehabilitative care, 3 months post total knee replacement. The secondary objectives of the study will be to compare functional, clinical performance and quality of life outcomes following use of the Maxm Skate compared with standard rehabilitative care. An economic evaluation assessing the relative cost-effectiveness of the Maxm Skate rehabilitation device compared to standard care will be also be conducted. Adverse event occurrences and complications will be screened from the time of consent to 1 year postoperatively. We aim to recruit a study sample size of 116 participants, with 58 per group. The primary endpoint is range of movement (ROM) which will be analysed on an intention to treat basis, using linear regression.

The specific aim of this study is to assess if recovery measures and next day performance can be enhanced in well-trained Water Polo athletes through exposure to the phytochemicals found in tart cherry juice. Results will be applicable to elite waterpolo players and team sport athletes. It is hypothesised that cherry jucie would improve recovery and limit any decline in performance at the end of 7 days of hard Water Polo training.

The primary purpose of this trial is to evaluate whether motivational interviewing, when added to a standard cancer rehabilitation program, improves physical activity levels and other health and well-being related outcomes. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over, have been diagnosed with any cancer for which you are currently undergoing treatment or have completed adjuvant therapy in the last 12 months, and have been referred for rehabilitation at Eastern Health. Study details All participants will receive the standard oncology rehabilitation program, which lasts 7 weeks and involves weekly group exercise and education sessions as well as a home exercise program and exercise diary. Participants will be randomly allocated (by chance) to receive this rehabilitation program alone, or to receive motivational interviewing from a physiotherapist via telephone in addition to the rehabilitation program. Participants allocated to this motivational interviewing group will receive 7 weekly telephone calls from a physiotherapist, of approximately 30 minutes in duration, to encourage participants to complete more physical activity. Participants will be asked to wear an activity tracking device and complete a number of questionnaires and physical function tests at the end of the 7 weeks, and some participants will also complete interviews with researchers to provide feedback on the program. It is hoped that this trial will provide evidence about the use of motivational interviewing during an oncology rehabilitation program to inform therapists and managers whether this is an effective intervention to facilitate positive physical activity behaviour.

this trial aims to improve the experiences of children with ASD having an operation in Royal Dental hospital and the Royal Children's Hospital . The participants will be selected from operating list and a preparation package will be sent after verbal consent. on the day of operation if the child requires premedication, they are randomised to clonidine plus midazolam at lower doses vs. placebo plus standard dose of midazolam. the primary end point is the quality of induction as measured by Almanrader scale.

This research project is being conducted to look at how safe, well tolerated and effective a new drug called DUR-928 is when given as an interlesional injection to participants with plaque-type psoriasis. The study will look at comparing the study drug’s safety, tolerability and effectiveness as a treatment for psoriasis using 2 different formulations when compared against placebo vehicle formulations, an active comparator and no treatment at all.

Project Aim: To determine whether there is a relationship between low Mannose Binding Lectin concentrations (a protein produced in the liver, that acts in the recognition of disease causing pathogens) and frequent Urinary Tract Infections (UTIs) in patients who have an autoimmune disease. Hypothesis: MBL deficiency predisposes to frequent UTIs in female patients with auto-immune diseases

This study aims to quantify clinical benefit of Magnetic resonance imaging (MRI) during lung cancer radiotherapy. Who is it for? Participants aged 18 years or over and have histological or cytological confirmed lung cancer scheduled to be treated with 12 or more fractions of treatment. Study details: All participants in this study will undergo MRI scans in addition to standard scans used during radiotherapy treatment (CT and PET). Participant of this trial will undergo a total of six MRI scans which will be performed before radiotherapy treatment starts, and at treatment day 1, day 11 and day 21 (where applicable), and three and six months post treatment completion. MRI scans acquired will not alter or impact participant’s treatment intent.This study will not impact on the participants standard treatment.

The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for intra-arterial catheters (IAC). The RCT aims to (i) identify clinical, cost-effective methods to prevent catheter failure due to infection, phlebitis, occlusion, and dislodgement; (ii) compare usual care dressings with a novel method; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles. You may be eligible to participate in this trial if you are an intensive care patient over the age of 16 and are having an intra-arterial catheter inserted as part of your therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to receive one of two IAC securement options. These will be either (i) the standard simple polyurethane dressing; or (ii) an integrated securement device and simple polyurethane dressing combined into a single device The allocated dressing will be applied from device insertion until the time of device removal. Participants will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, and device failures. It is hoped that the findings of this trial will provide information on which IAC securements are most effective in preventing IAC failure.

The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for peripheral intravenous catheters. The RCT aims to (i) identify clinical, cost-effective methods to prevent catheter failure due to infection, phlebitis, occlusion, and dislodgement; (ii) compare usual care dressings with a novel method; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles. Your child may be eligible to participate in this trial if your child is a medical, cardiac or surgical patient under the age of 18 and are having a peripheral venous catheter inserted as part of their therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to receive one of three PVC dressing/securement options. This will be either the standard bordered polyurethane dressing; medical grade superglue, or an integrated securement device. The allocated dressing will be applied from device insertion until the time of device removal. Participants and families will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PVC securements and dressings are most effective in preventing PVC failure.