None listed
Conditions
Brief summary
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.
Interventions
Pilot 3-arm randomised controlled trial investigating the effects of Robotic-Assisted Gait Training (RAGT) in children with cerebral palsy (CP)
Arm 1: Six-week waitlist then random allocation into two or four (30-40 minute) RAGT sessions per week for six weeks.
Arm 2: two (30-40 minute) sessions of RAGT per week for six weeks
Arm 3: four (30-40 minute) sessions of RAGT per week for six weeks.
RAGT sessions: approximately 1 hour, with 30-40 minutes of this active 1:1 (individual) therapy using th
Pilot 3-arm randomised controlled trial investigating the effects of Robotic-Assisted Gait Training (RAGT) in children with cerebral palsy (CP) Arm 1: Six-week waitlist then random allocation into two or four (30-40 minute) RAGT sessions per week for six weeks. Arm 2: two (30-40 minute) sessions of RAGT per week for six weeks Arm 3: four (30-40 minute) sessions of RAGT per week for six weeks. RAGT sessions: approximately 1 hour, with 30-40 minutes of this active 1:1 (individual) therapy using the Lokomat Pro in sessions conducted by the Robotics and Innovation Physiotherapist at the Women's and Children's Hospital. These sessions will be carried out at the Little Heroes Foundation Centre for Robotics and Innovation at the Women's and Children's Hospital. All sessions are conducted following the Hocoma Lokomat manual, and directions and session plans are created based on clinical reasoning by paediatric physiotherapists. In the first session of the intervention blocks, pre-assessment data will be collected and recorded (approximately 1 hour) before an acclimatisation session in the Lokomat®Pro (30-40 minutes). Each subsequent intervention session will be 60 minutes long which will include around 10-20 minutes of heart rate and blood pressure measures, set up and fitting time, 30-40 minutes of active RAGT, and five minutes for completion of final assessments. During the active RAGT period, a range of avatar-based games and biofeedback information will be used to target different goals as determined by the COPM assessment. The three Lokomat® variables that will be adjusted regularly throughout sessions are treadmill speed, weight support and guidance force. These changes will be made subject to Borgs rating of percieved exertion scores being ideally 13. Treadmill speed would be increased, and weight support decreased if it appears the child requires an increased challenge or is progressing well between sessions. Guidance force is the amount of assistance the Lokomat® is providing the child to walk in the physiological gait pattern. This would be decreased to provide an additional challenge or as a motivational technique using the biofeedback charts. Throughout the RAGT sessions, children will be given feedback on progress as compared to previous sessions and achievements can be logged and shown in real time on the video screen. At the last intervention session, the post-assessments will be undertaken (approximately 1 hour). The assessments will be repeated six weeks after the intervention period.
Sponsors
Women's and Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: •Children with a diagnosis of Cerebral Palsy •GMFCS level of II-IV •Aged 5 to 14 years •Able to follow instructions, and to participate in a minimum of 45 min of active physical therapy •Able to communicate pain, discomfort and report on perceived level of exertion
Exclusion criteria
Exclusion Criteria: •Body weight: less than 15kg or more than 135kg •Femur length: less than 23cm or more than 47cm •Unable to sustain vertical position for >20 minutes (orthostatic) •Knee flexion contracture of >10° •Knee valgus >40° •Orthopaedic surgery <9 months for soft tissues and <18 months for lower limb bony surgery •Botulinum Toxin (Type A) injection in the previous four months or planned during study period •Uncontrolled seizure disorder •Weight-bearing restrictions •Pregnancy •Behavioural problems/inability to offer consent in addition to guardian.
Outcome results
None listed