ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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4 results sorted by trial registration date.
  • Can robotic technology assist children with cerebral palsy after botulinum toxin injection?

    Botulinum toxin to treat lower limb hypertonia has been shown to benefit children with cerebral palsy when coupled with therapy. There is little consensus on the details of the therapy regimes. There is concern about the potential effects for the Botulinum toxin to produce significant atrophy in the muscle, felt to be related to repeated injections. Efforts to limit the number of injection episodes by prolonging the effects of the toxin should be explored. This study aims to investigate if the duration of effect of Botulinum toxin injection in the legs of children with cerebral palsy differ with robotic-enhanced therapy compared to conventional therapy. The study will also investigate whether robotic-enhanced therapy is judged to be more or less engaging and fun for participants, and if it is cost effective.

  • Can robotic-assisted therapy help children with acquired brain injury?

    This study is looking at whether the use of robotic technology can assist youth with acquired brain injury function better in their lives. This is important because we know from previous studies that functional improvements in brain injury, such as better walking, can come from more intensity of therapy (doing lots of therapy). Robotic technology may be a fun way to provide this therapy to young people. Based on studies in people with neurological conditions it is felt that the technology could assist, but further studies are needed to determine whether this is true. This study is being conducted to assist in answering that question. This study will involve two robotic machines - the Lokomat and the Armeo. The Lokomat is a robotic device to assist with walking and endurance. You/your child will be fitted to the device and while using it have the opportunity to engage with the interactive software used for fun and motivation. The Armeo is an upper limb robotic device that allows for practice of upper limb (arm and hand) skills, movement and strengthening. This device is connected to computer graphics with games and activities to motivate you/your child to complete activities. They allow for repetitive functional movements with instant feedback and the user practices these movement skills in virtual reality games. They are both located in the Little Heroes Foundation Centre for Robotics and Innovation at the Women's and Children's Hospital. Initially you/your child will be randomly allocated to one of two treatment groups: robotic therapy or conventional physiotherapy (usual land-based physiotherapy). Then, after a 6 week break, will be crossed over into the other group for the second treatment block. All participants therefore get to experience both robotic and conventional physiotherapy. In each treatment group you/your child will receive 15 training (therapy) sessions in total over a 5 week period. Each training session should take approximately 1 hour to complete. There is a series of assessments (muscle length, walking speed, walking endurance etc) that will be conducted by an assessment physiotherapist before and after treatment blocks and at a 3 month follow up. We expect these to take about 1 hour each time.

  • What are the possible benefits of Robotic-Assisted Gait Training and how much training is needed: A pilot randomised clinical trial with children with Cerebral Palsy.

    Gait disorders in children can result from a number of conditions including cerebral palsy (CP), myelomeningocoele and traumatic brain injury. Such disorders can have a profound effect on the components of walking, as well as the functional participation of children in their home, school and other natural environments. Robotic-Assisted Gait Training (RAGT) is an emerging option in physical rehabilitation for adults and children with disorders impairing their ability to walk. RAGT devices such as the Lokomat®Pro support an individual on a treadmill while the robotic exoskeleton moves the lower limbs to simulate walking. There have been positive results from the use of RAGT in adult spinal cord injury and stroke populations for improvement in gait speed and endurance; however, the outcomes were not always better than traditional physiotherapy. Currently, there is weak and inconsistent evidence that RAGT may benefit children with CP with recommendations that higher level research investigates the role and potential of RAGT in this population. Additionally, many studies have failed to consider the impact of RAGT on participation outcomes. A limitation of the current literature is that no study has investigated different training schedules (frequency and intensity) of RAGT in children with CP and there is no consensus on the best schedule to promote functional improvement. Therefore, this study aims to investigate how RAGT should be prescribed and its impacts on body structure and function, activity and participation domains of the ICF. This research has the potential to aid in the development of clinical practice guidelines for the use of RAGT in children with CP. Aims of research This project will pilot test robotically-assisted gait training (RAGT) in children with cerebral palsy to: 1. Establish the most effective dosage for RAGT in terms of a) frequency and b) intensity of session, to induce clinically meaningful improvement in lower limb functioning, (as measured by the outcome measure listed in 'procedures and measurement') 2. Establish the measurements of outcome that demonstrate the most improvement from baseline after treatment to capture relative effectiveness across the ICF domains. Hypotheses: 1. In children with CP, we hypothesise that a relationship exists between increased intensity and/or frequency of RAGT sessions and clinically meaningful improvement in lower limb performance (on ICF outcome measures). 2. We hypothesise that the greatest change in outcome measures will occur in the group with the higher dosage of RAGT therapy.

  • Determining if a customised "in-home" computer gaming system can improve sensory function in the hands of children with cerebral palsy.

    This study aims to determine if children with cerebral palsy (CP) who have a known tactile sensory deficiency in their hands can have that sense of touch improved, hence improving their overall hand and arm function. The intervention uses a specialised joystick to play a range of custom-made computer games that are aimed at captivating the interest and motivation of children with CP while providing tactile feedback to their hands to increase the realism and sense of game-play. Our hypothesis for this project is that tactile sensory perception can be improved in children with CP through a computer-based program that couples a fun, engaging and motivational activity with an opportunity to experience a range of appropriate sensory inputs.

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