Active Strides-CP is a novel package of physiotherapy targeting body functions, activity and participation outcomes for children with moderate to severe bilateral CP. This study will compare Active Strides-CP to usual care in a large multi-site randomised waitlist-controlled trial. For children with moderate to severe bilateral cerebral palsy (CP), who are marginally ambulant, gross motor capacity peaks between 6-7 years of age with a subsequent clinical decline, impacting their ability to engage in health enhancing physical activity.
A total of 150 children with bilateral CP (5-15years), classified in GMFCS levels III and IV will be recruited and then stratified (GMFCS III vs IV, age bands 5-10 years; 11-15 years and trial site) and randomised to receive either (a) 8 weeks of Active Strides-CP two times/week for 1.5hours in clinic and one time/week for 1hour alternating home visits and telehealth (total dose 32hours) or (b) usual care. Active Strides-CP comprises Functional Electrical Stimulation Cycling, Partial Body Weight Support Treadmill Training, overground walking, adapted community cycling and goal-directed training. Outcomes will be measured at baseline, immediately post intervention at 9-weeks primary endpoint at and at 26-weeks post baseline for retention of treatment effects. The primary outcome is the Gross Motor Function Measure-66. Secondary outcomes include habitual physical activity, cardiorespiratory fitness, walking speed and distance, frequency/involvement of community participation, mobility, goal attainment, healthcare use and quality of life.
The Children’s Health Queensland Hospital and Health Service, The University of Queensland, The University of Melbourne and Curtin University Human Research Ethics Committees have approved this study. The study has commenced in Perth with 3children recruited and 2 undertaking the Active Strides program
- The Active Strides-CP intervention uniquely combines elements of motor training and environmental modification to address both gross motor capacity and restrictions in participation in physically active leisure.
- A combination of clinic-based and home-based program will promote transfer of gross motor capacity gains into improved mobility and participation in physically active leisure in the community.
- Retention of treatment effects will be examined 18 weeks after completion of Active Strides-CP.
- A within-trial cost utility analysis will be conducted.
To find out more about the project, contact: Study Co-ordinator Dr Natalie Dos Santos, n.dossantos@uq.edu.au
Investigators: A/Prof. Leanne Sakzewski, Dr Dayna Pool, Curtin University, Perth, Dr Ellen Armstrong, Griffith University, Dr Sarah E Reedman, The University of Queensland ; Prof. Roslyn N Boyd, The University of Queensland. Prof Catherine Elliott, Curtin University and Telethon Kids Institute, Perth, Iona Novak, Cerebral Palsy Alliance Research Institute, The University of Sydney, Sydney, Prof. Stewart G. Trost, The University of Queensland, Brisbane, Robert S Ware, Griffith University, Brisbane; Prof. Tracy Comans, The University of Queensland, Dr Rachel Toovey, The University of Melbourne, Prof. Mark Peterson, University of Michigan, Michigan, USA; Megan Kentish, The University of Queensland, Paediatric Rehabilitation Service, Queensland Children’s Hospital, Sean A Horan, Griffith University, Jane Valentine, Telethon Kids Institute, Perth, Sian Williams, Curtin University, School of Allied Health, Perth, Australia and Liggins Institute, University of Auckland, New Zealand.
Active Strides-CP is supported by a National Health and Medical Research Council Clinical Trials and Cohort Study grant (NHMRC 2006867) Aus$2.4M
