ANZCTR search results

This research seeks to improve the exercise options available to people with multiple sclerosis (MS). As MS worsens, the ability to perform aerobic exercise becomes difficult due to leg and/or arm paresis and the possible effects of MS related fatigue. The main purpose of the study will be to assess whether the technology of functional electrical stimulation can assist people with moderate MS to exercise at a higher intensity than they might otherwise be able to do. The results will increase the understanding around when voluntary cycling can be of benefit and when the addition of functional electrical stimulation might be beneficial in assisting persons with MS to exercise more effectively.

The purpose of this study is to assess if the use of a robotic arm during TKR surgery results in better patient outcomes compared to the conventional method of using company instruments (jigs). In recent years there have been many technological advancements to help surgeons be more accurate in how they put in the components during TKR. The most recent advancement is the development of a robotic arm (ROSA) that assists the surgeon in performing the bony cuts required during surgery before putting in the components of the TKR. Traditionally, this part of the procedure has been performed with the help of company instruments called jigs. While the accuracy of component implantation may be better with the use of the robotic arm, we still do not know if the use of the robotic arm means better patient outcomes compared to the standard method of using company instruments (jigs) in TKR.

This study aims to evaluate the effects of a family-based surfing intervention on the physical and psychological wellbeing of children and adolescents with chronic conditions. Who is it for? You may be eligible for this study if you are a patient with one of the following conditions and aged 7-18 years: Cystic Fibrosis, Post-Burn Injury, Juvenile Idiopathic Arthritis, Cerebral Palsy, Sarcoma, or Type I Diabetes. Study details Participants who choose to enrol in this study will be randomly allocated to either receive the surfing intervention, or no intervention at all. Those in the surfing group will complete 12 one-hour surf lessons over 8 weeks, with the same instructor. All participants will complete questionnaires collecting data on factors such as psychological wellbeing, physical activity and family relationships. It is hoped that data from this study will help determine whether a family surfing program may lead to potential ongoing and low-cost health benefits for participants.

The primary aim of this project is to test the feasibility of recruitment, retention, data collection and analysis for a fully-powered randomised controlled trial (RCT). This is to evaluate the effectiveness of the rebozo technique in improving birth experiences and outcomes in first time mothers utilising epidural analgesia. As the rebozo technique is an under-researched method to optimise fetal position for labour and birth, a pilot RCT is needed to determine feasibility to a fully-powered RCT. The study participants will be low risk first time mothers using an epidural. The intervention will be the rebozo technique, and the comparison group will be standard care provided by midwives. Primary outcomes are proportion of women who meet inclusion criteria give consent to participate; proportion of women who give consent are randomised; proportion of women who receive allocated intervention; proportion of participants who withdraw from the study; proposition of participant data collection sheets completed; and number and nature of adverse events.

This project will determine whether atrophy of the quadriceps muscles in previously ACL injured limbs is due to an inability to activate key molecular signalling pathways that govern maintenance of muscle mass and the ability to regenerate new muscle tissue. We will provide both functional and mechanistic evidence regarding how ACL injured limbs have a reduced capacity to build muscle. The findings from this work will assist in the development of interventions aimed at improving muscle building capacity in the quadriceps in individuals following ACL injury. Hypothesis: Following exposure to strength/rehabilitation (resistance-based) exercise, limbs with a history of ACL injury will demonstrate impaired activation of key molecular pathways underlying muscle growth, compared to non-injured limbs. Study design: A within-participant cross-sectional study will permit investigation of differences in exercise-induced molecular pathway within the same participant between his/her limbs (with/without a prior ACL injury) at rest and immediately following a single bout of strength/rehabilitation exercise.

This study aims to test if it is practical to conduct a one-off multi-disciplinary team (MDT) consultation for patients with advanced non-small cell lung cancer, focussing on survivorship care needs. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have advanced non-small cell lung cancer, and have been receiving your current cancer treatment for at least 6 months without the disease getting worse on scans. Study details All patients who enrol in this study will be invited to participate in a single, 30-minute, multi-disciplinary team (MDT) meeting via a secure, online video-conferencing platform. The meeting will focus on any unmet needs and concerns the participating patient may have related to survivorship, with discussion led by a lung cancer specialist nurse from the hospital. The MDT will include the patient (+/- a family member), hospital doctor, allied health professional, and a member of the patient’s primary care team (ideally the patient’s GP). Prior to the MDT meeting, all patients will be asked to complete a survey to identify survivorship concerns in order to guide the MDT discussion, and they will receive a 15-minute call by a member of the study team prior to the MDT meeting. The patient’s GP will also be asked to complete a 5-minute questionnaire prior to the MDT. After the MDT meeting a survivorship care plan will be produced summarising the discussion at the MDT meeting, and a copy made available to the patient, the patient’s GP and placed in the patient’s hospital record. Three months after the MDT meeting, participating patients and GPs will be asked to complete a short follow-up questionnaire about how acceptable the MDT meeting process was. Later on (4-4.5 months post participating in the MDT meeting) some patients and their GPs will also be invited to participate in an interview to discuss their impressions of participating in the MDT meeting. Rationale It is hoped that this study will show that a MDT consultation is both feasible and acceptable to patients, hospital and community-based health-care providers, and enable further implementation of these consultations to improve the survivorship care for patients living with advanced non-small cell lung cancer.

The purpose of this study is to assess the effect of adding perforations to scleral contact lenses upon; 1) corneal tissue swelling, 2) tear flow behind the contact lens, and 3) build up of debris behind the contact lens in young healthy adults during short-term lens wear (3.5 hours). The null hypothesis is that the incorporation of scleral lens perforations will have no significant effect upon the primary outcome measures (1,2,3 listed above).

The purpose of this study is to investigate the long-term impact of wearing minimalist school shoes on a child’s (9 – 12 yrs) foot muscles and balance. The hypothesis, based on previous research is that over time, with no externally imposed shoe movement restrictions (such as with normal stiff school shoes) the child’s balance will improve and their foot muscles will increase in size and strength.

The Kinephonics app is a new technology to support people with communication difficulties using speech entrainment intervention technique. It is hypothesised the app, with the support from a support worker or allied health assistant, can help adults with a range of backgrounds (including stroke, developmental disorder, autism, brain injury) with improving their speech and language skills. The current study is a pilot study, which will inform the development of a future large clinical trial. The primary objectives of the study are to a) determine the acceptability and feasibility of conducting the study for a large clinical trial in the future using the Kinephonics app with support workers and allied health assistants implementing the intervention; and b) to determine the effect of the Kinephonics app on various speech and language outcomes. Following an assessment visit to capture communication outcomes, participants will be randomised to immediate intervention group or waitlist control group. Each group will receive Kinephonics® speech entrainment sessions 20-30 minutes 1-2 weekly for a total of 12 sessions within 6 weeks. Outcomes will be assessed after each intervention/usual care phase, and 1 month after all phases. fMRI neuroimaging on 20 participants with a background of a stroke before and after the intervention to identify neurological changes with Kinephonics® use is an optional component of the study. Outcomes which will be measured include: * Number of intervention sessions participants attend * Support worker and allied health assistants following the Kinephonics training and intervention requirements * Receptive and expressive language skills before and after the intervention * Speech skills before and after the intervention * Fatigue ratings after participating in the intervention * Optional functional MRI for stroke participants to measure neurological changes * Optional interview to discuss participant and family experience with being in the study

This clinical trial aims to assess the effect of a combination therapy with Venetoclax, Iberdomide and Dexamethasone for the treatment of patients with first or second relapse of Multiple Myeloma t(11;14). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with Multiple myeloma and have had 1-2 prior lines of treatment. Study details Participants who choose to participate in this trial will receive cycles of combination treatment. Each cycle is 28 days in length. The treatment is 3 products that will be used in combination. The first product, Venetoclax is an oral treatment and participants will take this from day 1 to day 28 of each cycle. The second product, Iberdomide is also an oral treatment and participants will take this from day 1 to day 21. The third product is Dexamethasone which participants have most likely had before. Dexamethasone will be taken on days 1, 8, 15 and 22. Participant will continue on the treatment combination until they are no longer responding to the therapy, or if the treatment causes too many adverse events. Safety assessments will be carried out by the Chief Investigator and trial committee. It is hoped this research will determine whether the combination of Venetoclax, Iberdomide and Dexamethasone is successful at treating people with relapsed or refractory multiple myeloma. If this combination treatment is found to be effective, it may be used to improve the health outcomes of future patients with refractory and relapsed multiple myeloma.