None listed
Conditions
Brief summary
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.
Interventions
Robotic assisted therapy intervention arm.
Approx 1-1.5 hour individual therapy sessions, 3x week over a 5 week period. Treatments alternate between conventional therapy and robotic therapy during this period (15 sessions in total - 8 robotics and 7 conventional).
During robotic therapy sessions two robotic devices, the Armeo and Lokomat will be used. Armeo is designed to improve arm function and Lokomat to improve walking. These sessions will be administered by a senior physiotherapist who i
Robotic assisted therapy intervention arm. Approx 1-1.5 hour individual therapy sessions, 3x week over a 5 week period. Treatments alternate between conventional therapy and robotic therapy during this period (15 sessions in total - 8 robotics and 7 conventional). During robotic therapy sessions two robotic devices, the Armeo and Lokomat will be used. Armeo is designed to improve arm function and Lokomat to improve walking. These sessions will be administered by a senior physiotherapist who is an expert with the robotic devices. There will be 30-40 minutes of Lokomat and 20-30 minuntes of Armeo per session. They will be conducted at the Little Heroes Foundation Centre for Robotics and Innovation located in the Women's and Children's Hospital in Adelaide, South Australia. Participants will receive guidance and encouragement from therapists and get visual biofeedback from the devices and play virtual reality games. Conventional sessions will consist of current standard-practice manual exercises overseen by a clinical expert paediatric physiotherapist for improving gait, balance and functional abilities. They will be one on one sessions of 30-45 minute duration. Exercises will be goal directed and chosen at the discretion of the treating physiotherapist from intervention areas including functional strengthening, isolated strengthening, gait training, cardio-respiratory training, balance/core exercises and motor skill learning. Exercises will progress in difficultly to remain challenging for each client and reviewed at the end of each week. Participants will receive encouragement from therapists and general verbal performance feedback in order to engage participants as much as possible and to increase their active participation and motivation. There is a 6 week washout period between interventions.
Sponsors
Women's and Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
- Limitations in gross motor functioning resulting from an acquired brain injury (ABI) - Diagnosis of ABI in paediatric age and adolescence (4-18 years) - Had sustained the ABI 12 months prior to recruitment. - Participant has both upper and lower limb functional goals - Femur length greater than 21cm and upper arm greater than 16cm - Able to fit to both arm and leg orthosis - Able to comprehend and follow instructions for robotic therapy - Ability to signal pain/fear/discomfort to therapist
Exclusion criteria
- Contraindications to the Lokomat or Armeo and/or participation requirements (pregnant, orthopaedic, language, cognitive or behavioural impairments) - severe contractures, fractures, osseous instabilities and osteoporosis - Open skin lesions on extremities - Aggressive or self-harming behaviour - Neurological or cognitive-behavioural deficit/impairment manifested before the ABI event
Outcome results
None listed