None listed
Conditions
Brief summary
Cerebral palsy is the most common cause of physical disability in childhood. Physiotherapy is an important patient focused healthcare delivery intervention that is necessary to improve functioning of muscles, walking and in the prevention of deformities. The life-long impact of cerebral palsy is higher than many conditions because of the early age onset. Hence physiotherapy needs to be provided from an early age to influence not only muscular structure (such as strength and flexibility) but also neurological structures such as the brain - which can learn and change when given the right stimulus to do so. There has been a recent paradigm shift in how to train and promote walking in people with neurological conditions. Activity and intensity of training are crucial and much of this has been drawn from neurological research and spinal cord injury research. It is increasingly recognized that teaching the pattern of walking is important to stimulate the central pattern generators – the intrinsic and reflexive pathways in our neurological system that guide movement. This approach is not well understood in the area of cerebral palsy but given the theoretical foundation combined with our clinical experience and observations that have demonstrated feasibility and potential efficacy, a controlled larger scale study is necessary. This is particularly relevant because technology is now increasingly available in the community but is supported by limited evidence. Evidence based approaches are necessary to ensure ethical use of limited funds. The significance of this research recognizes that one in three children with cerebral palsy cannot walk and rely on equipment aides and physical support from carers. Hence programs focusing on walking will address known issues due to sedentary behaviour in children with cerebral palsy and in the prevention of obesity and pain. Such interventions will improve independence and functioning hence reducing the burden of care, which is by far, accountable for the highest economic impact of this condition. Therefore training to walk at an early age even with the use of mobility aides such as walking frames actually translates to increasing and maintaining movement, strength, independence, function, participation and well-being to reduce the burden of care not just for short term gain but well into the future as children become adults. This approach combines the knowledge and principles needed to improve muscular structures, central pattern generators and an avenue to improve walking speed and endurance in young children with cerebral palsy even though children are classified as having lower gross motor function (GMFCS III, IV and V). The primary aim of this research is to determine if robotic assistive rehabilitation improves functional mobility in children with cerebral palsy who usually require assistance to walk and reduced burden of care for their parents and families.
Interventions
The intervention group will receive a 6 week FES robotic assisted locomotor training program 3 times a week for 6 weeks. Each session will be 1.5 hours in duration and will be comprised of 3 main parts. The first part will include bilateral neuromuscular electrical stimulation (NMES) to the hamstrings and quadriceps while using the RT600 - an FES robotic locomotor device that synchronises NMES during a gait cycle (30 minutes). The second part will be a treadmill body weight supported locomotor p
The intervention group will receive a 6 week FES robotic assisted locomotor training program 3 times a week for 6 weeks. Each session will be 1.5 hours in duration and will be comprised of 3 main parts. The first part will include bilateral neuromuscular electrical stimulation (NMES) to the hamstrings and quadriceps while using the RT600 - an FES robotic locomotor device that synchronises NMES during a gait cycle (30 minutes). The second part will be a treadmill body weight supported locomotor program both with and without physical facilitation (20 minutes). The treadmill program will be based on principles of fitness training using intervals that are determined by individual heart rate responses (aiming for 50-70% HRMax i.e. moderate to vigorous physical activity). Finally, children will practice overground walking in their walking frames with focus on improving functional use through lower limb patterning and steering ability (15 minutes). The remaining 25 minutes will include preparation into the harness, placement of electrodes and transfers between equipment. Attendance will be registered as well as clinical progress notes (as per standard clinical practice) to document subjective reports, objective observations, individual responses and evaluation of treatment session.
Sponsors
Dayna Pool
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Children with bilateral spastic cerebral palsy (may include mixed signs with dyskinesia and hypertonia) Aged between 5 and 12 years Able to follow simple instructions (to perform the 10 meter walk test) Gross motor function classification system Level III, IV or V i.e. those who typically require mobility devices to walk Accepted to receive iRehab services through Princess Margaret Hospital (tertiary level referral) Parent identified performance problems that include difficulty with transfers or difficulty with use of walking frame and mobility Current use of an assistive walking device (must already have one and is currently being used) Children must have a community therapy provider Children must be at least 3 months post botulinum toxin injections
Exclusion criteria
Engagement in activity based rehabilitation locomotor training in the past 6 months Uncontrolled seizure disorder Orthopaedic Surgery in the past 12 months
Outcome results
None listed