None listed
Conditions
Brief summary
ACTIVE STRIDES-CP: Effect of Intensive rehabilitation for children with moderate to severe cerebral palsy on gross motor skills and physical activity participation. In Australia, 420 infants are born annually with cerebral palsy (CP), making it the most common physical disability in childhood. Of these infants, 40% will have moderate to severe motor disability which is associated with reduced general health, greater pain and discomfort, reduced independence in daily life skills and participation in physical activity, and poorer vocational outcomes. We have promising data about a new intervention, called Active Strides-CP, which we will test in 150 children with bilateral cerebral palsy and compare results to usual care. Researchers from The University of Queensland, led by A/Professor Leanne Sakzewski in partnership with researchers in Sydney, Melbourne and Perth are testing a new rehabilitation approach for children with moderate to severe cerebral palsy to help improve gross motor abilities, and participation in physically active leisure in the community. This novel approach combines a package of gait training using treadmills, overground walking using assistive devices, cycling and targeted training of gross motor goals with a total of 32 hours of training provided over an eight week period.
Interventions
ACTIVE STRIDES-CP is an intensive program of Functional Electrical Stimulation Cycling, Partial Body Weight Support Treadmill Training (PBWTT) and goal directed training.
Dose: We will deliver a total dose of 32 hours of direct therapy which will be delivered over 8 weeks. This comprises 2 x weekly clinic visits of 1.5 hours duration, 4 home visits of 1 hour duration (alternate weeks) and 4 telehealth sessions of 1 hour duration (alternative weeks to home visits.)
Mode: Individual intervention
ACTIVE STRIDES-CP is an intensive program of Functional Electrical Stimulation Cycling, Partial Body Weight Support Treadmill Training (PBWTT) and goal directed training. Dose: We will deliver a total dose of 32 hours of direct therapy which will be delivered over 8 weeks. This comprises 2 x weekly clinic visits of 1.5 hours duration, 4 home visits of 1 hour duration (alternate weeks) and 4 telehealth sessions of 1 hour duration (alternative weeks to home visits.) Mode: Individual intervention with a ratio of 2:1 therapist + therapy assistant for child on-site training. Face-to face clinic sessions and home visits. Telehealth for 4 sessions. Intervention Providers: Physiotherapists or exercise physiologists delivering ACTIVE STRIDES CP will complete standardised training provided by the CI team. The trained providers will provide direction to allied health assistants assisting with the on-site (clinical setting) sessions. Content and tailoring: ACTIVE STRIDES-CP is a motor training approach comprising a rehabilitation package of up to 30 mins/session each of (i) assisted FES cycling, (ii) partial body weight support treadmill/ over ground walking, and (iii) planning/revision of the goal directed home exercise program (based on functional goals targeted at activity performance or participation) and 4 x fortnightly 1hr home visits to practice recreational cycling (individualized adapted bike), over ground walking (using gait trainers) and goals in context, and on alternating weeks, 4 x fortnightly 1hr telehealth sessions. FES cycling consists of 3 x 10 minute cycling phases ( 2 x self-selected cadence, 1 sprints). The aim will be to progress speed, resistance and power output each session. PBWSTT comprises 3 x 10 minute sets using a treadmill and overhead hoist. Over time, speed will be increased and support will be decreased. Two to three functional mobility or cycling related goals will be set and developed as a home program. Target intensity: During FES cycling, training intensity is aimed to be >60% of age-predicted heart rate maximum for two phases and >80% during sprints. During PBWSTT, training intensity is aimed to be 70% heart rate maximum. Fidelity: All providers will complete standardised training to deliver ACTIVE STRIDES-CP and meet specified competencies to deliver each aspect of the intervention. Following each intervention session, therapists will complete a session checklist and reflection to ensure that all elements have been recorded, and that ongoing incrementation of the program is occurring. Intervention sessions will be video recorded and a random sample reviewed against a bespoke fidelity checklist (first 2 sessions for each interventionist and then 10% of sessions thereafter).
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Children diagnosed with bilateral CP (diplegia/quadriplegia), GMFCS III (walks with limitations) to IV (limited self-mobility); (b) aged 5-15 yrs; (c) have goals to improve mobility, cycling, sit-to-stand or stepping transfers; (d) able to attend training, testing and follow-up sessions; (e) able to follow instructions to perform GMFM and intervention; (f) not expected to undergo lower limb orthopaedic or neurosurgery (e.g. Selective Dorsal Rhizotomy) during the study period. If they have received lower limb orthopaedic surgery in the previous 12 months then study entry will be delayed; (g) medically fit to undertake moderate intensity exercise; (h) adequate range of motion (ROM) in their hips, knees and ankles to complete a full revolution of the RT300 cycle (Restorative Therapies Inc., Baltimore) crank arm; (i) able to verbally or non-verbally communicate pain or discomfort.
Exclusion criteria
(a) lower limb joint contracture, severe spasticity or severely reduced ROM that limits ability to complete a full cycling revolution; (b) uncontrolled epilepsy (not controlled by medication) as this would be a confounder; (c) surgery, trauma or fractures in the preceding 12 months without medical clearance to participate; (d) cardiovascular or pulmonary diseases without medical clearance to participate in the 8-week intervention.
Outcome results
None listed