ANZCTR search results

In this project, we will explore the clinical utility of novel integrated E-Tattoo surface EMG sensors by measuring the activity of spastic muscles in the arm or leg at a participant’s first and follow-up appointments at the Spasticity Clinic at the Royal Park Rehabilitation Centre. Electrodes will be placed over the overactive muscle and its opposing muscle and the data about the activity of each muscle during some tests of physical function. Participants will be asked about their experience of wearing the E-Tattoo electrodes. The project explores the application of E-Tattoo electrodes for the first time in the measurement of spasticity, as an example of their potential use for personalized health care. We hypothesis that these electrodes will be comfortable for participants to wear and will provide data on muscle activity comparable to that obtained from traditional electrodes.

This project addresses a significant unmet need: recovery of arm and hand function in people with tetraplegia (loss of use of the arms and legs). This issue is ranked by survivors as being of the highest importance, more important than the ability to walk. A novel non-invasive method of spinal cord stimulation (transcutaneous spinal cord neuromodulation – TESCoN) will be trialled for the first time in Australia, and in both subacute and chronic tetraplegia. Electrodes on the skin at the back of the neck will deliver a unique form of stimulation to the spinal cord without causing discomfort. This will modulate (alter the activity of) spared but non-functional pathways as well as the spinal circuitry below the injury level. When combined with intensive rehabilitation of the arm and hand, TESCoN leads to altered connections within the spinal cord, resulting in improved function. TESCoN enhances the effect of intensive rehabilitation and is not a replacement for it. This study will be an open-label trial using an adaptive design, with a combined efficacy and safety endpoint and clear rules for stopping the trial if the intervention is shown to be ineffective and/or unsafe. TESCoN is expected to lead to improvements in function that are superior to those obtained with current best practice rehabilitation. Such recovery of function may have a substantial impact on independence, potential for employment, and quality of life.

This project addresses a significant unmet need: recovery of arm and hand function in people with tetraplegia (loss of use of the arms and legs). This issue is ranked by survivors as being of the highest importance, more important than the ability to walk. A novel non-invasive method of spinal cord stimulation (transcutaneous spinal cord neuromodulation – TESCoN) will be trialled for the first time in Australia, and in both subacute and chronic tetraplegia. Electrodes on the skin at the back of the neck will deliver a unique form of stimulation to the spinal cord without causing discomfort. This will modulate (alter the activity of) spared but non-functional pathways as well as the spinal circuitry below the injury level. When combined with intensive rehabilitation of the arm and hand, TESCoN leads to altered connections within the spinal cord, resulting in improved function. TESCoN enhances the effect of intensive rehabilitation and is not a replacement for it. This study will be an open-label trial using an adaptive design, with a combined efficacy and safety endpoint and clear rules for stopping the trial if the intervention is shown to be ineffective and/or unsafe. TESCoN is expected to lead to improvements in function that are superior to those obtained with current best practice rehabilitation. Such recovery of function may have a substantial impact on independence, potential for employment, and quality of life..

This study will specifically investigate whether functional electrical stimulation (FES) reverses myelin abnormalities in peripheral nerves of people with spinal cord injury. Participants who are scheduled to undergo nerve transfer surgery will be asked to undertake a program of FES using the ReGrasp device (Rehabtronics Inc, Edmonton Canada) for at least one hour dail, 5 days per week for 6 weeks prior to the surgery. This device enables a person to close and open the hand and can be operated independently by simple head motions detected by an earpiece. Biopsies of the relevant nerves and muscles will be obtained during the surgery, and these will be processed, analysed and compared with those obtained from previous nerve transfer surgery participants (historical controls). The primary outcome measure is the axon/nerve fibre ratio. Secondary outcomes include clinical assessments of hand function, independence, pain, well-being and quality of life, with participants being followed up for 24 months post-surgery. A cost-utility analysis will also be conducted.

Many people with stroke have walking and balance dysfunction. Sensory tongue stimulation (cranial nerve non-invasive neuromodulation – CNNINM) provided through a device called the Portable Neuromodulation Stimulator (PoNS) can stimulate regions in the brain that are important for balance and gait. This study will be a preliminary randomised controlled trial (RCT) of the PoNS combined with a structured task-specific rehabilitation program in stroke survivors undergoing inpatient rehabilitation.The study will be registered with the Therapeutic Goods Administration under the Clinical Trial Notification Scheme (device trial). Ten participants will be randomised to either a 2-week intensive balance and gait training program with a physiotherapist while using the PoNS (intervention), or to a 2-week intensive balance and gait training program with a physiotherapist only (control). Both the intervention and control programs will be conducted at the Royal Park Rehabilitation Centre, and will be additional to the patients' usual rehabilitation program. Training sessions will be tailored to the needs of each participant and comprise five main components: movement control, balance, gait, cognition and breathing and relaxation. Participants will be assessed on a range of outcome measures related to gait and balance, as well as self-perception of performance, depression, cognition and oculomotor function. Assessments will occur at baseline and post-intervention. The primary outcome measures will be the miniBEST Test, which assesses balance. This study will be the first systematic study of the PoNS in Australia, and will establish the safety and preliminary efficacy of the PoNS/training protocol. It will also provide data on which to base a sample size calculation for a future larger RCT.

Stroke is a major cause of disability worldwide, with 5 million people left permanently disabled. In Australia, total lifetime cost burden of first-ever stroke was estimated to be more than A$2 billion. A large contribution of these costs result from out-of-pocket expenses, informal care, and productivity losses associated with stroke. Loss of upper limb function contributes significantly to stroke-related disability and reduced independence. Functional recovery of the paretic upper limb after stroke continues to be one of the greatest challenges faced by rehabilitation staff. Yet despite a wealth of research showing that recovery of function is driven by repetitive task-specific training, rehabilitation of the arm and hand is given lower priority than retraining of walking. The major barriers include limited rehabilitation resources, difficulties with travel to rehabilitation facilities, and, for more severely impaired patients, the need for external assistance or guidance. We now propose to conduct a randomised controlled trial of in-home based tele-rehabilitation to actively exercise the affected upper limb in chronic stroke survivors using inexpensive, commercially available devices that enable participants to play computer games that encourage arm use and that can be progressed in level of difficulty. An on-line cognitive training program will be the active control intervention. We have previously shown that use of such devices in a centre-based program leads to improved arm function and quality of life. A parallel cost-effectiveness study will be conducted. If this intervention is found to be effective and cost-effective, it could be readily implemented as a practical, inexpensive, and motivating program of upper limb rehabilitation for stroke survivors in their own homes.

The aims of this project are to: 1) conduct a prospective case series of nerve transfer surgery in eligible patients with tetraplegia; 2) implement and refine a standardised protocol for clinical and neurophysiological assessment and post-operative therapy; 3) evaluate the outcomes and cost-benefit of nerve transfers. Fifteen patients with complete or incomplete SCI between C5 and C7, who are deemed suitable for surgery by the Upper Limb Program Team, will be evaluated. Participants will undergo thorough clinical and neurophysiological assessment pre- and up to 24 months post-operatively. Donor and recipient nerve and muscle tissue samples will be examined histologically, and functional tests of upper limb performance will also be conducted. Expected outcomes include evidence of the functional effectiveness of nerve transfer surgery, refinement of selection criteria and post-operative management, cost-benefit of nerve transfer surgery , and histological information about the health of the donor and recipient nerves and muscles.

Nutritional management of patients after spinal cord injury is complex and challenging. Dietitians currently estimate a patient’s nutritional requirements using standard equations of normal resting metabolism, adjusted for activity and stress levels. These equations have never been validated in the spinal cord injured population. To do this, metabolic activity will be measured using a technique called doubly labelled water. Patients are given a single dose of water labelled with a stable isotope. The elimination of the isotope over time directly measures metabolic activity. Weight loss, commonly used to detect malnutrition, cannot distinguish between muscle wasting associated with paralysis and wasting from malnutrition. This study will therefore validate the use of an objective and non-invasive technique called bioelectrical impedance analysis (BIA) to measure segmental body composition (muscle, fat and water) in acute spinal cord injury. With segmental BIA, muscle wasting due to paralysis can be distinguished from wasting due to malnutrition. BIA measures will be validated by dual energy x-ray absorptiometry (DEXA), the gold standard for analysing body composition. BIA can be conducted at bedside and is therefore more clinically feasible and cost-effective for on-going assessment in this population where nutritional needs change through different phases of recovery.

This study is a multi-centre, assessor-blinded, randomised controlled Phase I trial in people with spinal cord injury. This study is funded by a grant from the Victorian Neurotrauma Initiative. A total of 50 participants with complete or incomplete spinal cord injury will be randomised into two groups: an experimental group and a control group. The control group will undertake a passive cycling program using a bed bike while in the acute ward and an upright bike once they progress to rehabilitation. The experimental group will undertake a FES-assisted cycling program using a bed bike while in the acute ward and an upright bike once they progress to rehabilitation. Both programs will consist of 60 minutes of training 4 times per week for 12 weeks. Training will commence once the participant is considered medically stable (a minimum 5 days post-injury, maximum 4 weeks post-injury). The main objective of the study is to determine the relative effectiveness of FES-assisted cycling compared to passive cycling on muscle cross-sectional area of thigh and calf. The total study duration is 2 years, including an 18month recruitment period, a 12 week treatment period and post-intervention assessments (within a week of last treatment).

The main objective of the study is to determine whether the comprehensive exercise program leads to better neurological recovery than the upper body training program. Both programs are likely to lead to improvements in health and fitness