ACTIVE STRIDES-CP: Randomized trial of intensive rehabilitation (combined intensive gait and cycling training) for children with moderate to severe bilateral cerebral palsy

January 2022June 2028
National Health and Medical Research Council

 

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 (4-15years) or CP-like non-degenerative conditions, classified in GMFCS levels III and IV will be recruited and then stratified (GMFCS III vs IV, age bands 4-10 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 1 hour 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 is recruiting in Perth (Healthy Strides Foundation), Brisbane (Queensland Children's Hospital), Melbourne (Royal Children's Hospital and Monash Children's Hospital) as well as in Singapore at the Healthy Strides Foundation and KK Hospital.

  • 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.

 

Information for Parents

ACTIVE STRIDES-CP is a research study desgined to help children with cerebral palsy become more physcially active and reduce time spent sitting.

The program includes:

  • Two clinic-based therapy sessions per week (at one of our participating sites) for 8 weeks.
  • Eight additional sessions, including:
    • At least 2 home or community visits (e.g. school or park)
    • Up to 6 telehealth consultations
  • A total of 32 hours of free therapy

Each 1.5 hour includes:

  • Assisted FES cycling - to activate muscles using FES (Fuctional Active Stimulation)
  • Walking training - to improve mobility using partial body weight support treadmill
  • Goal-based activities - including sit-to-stand excercises, functional motor skill goals, adapted community cycling

 

To find out more about the project, contact Study Co-ordinator Dr Pam Gabrovska p.gabrovska@uq.edu.au

If you are a parent of a child with Cerebral Palsy or CP-like conditions and would like to find out if your child is eligible to participate, please complete the Expression of Interest form below:    

     

Expression of Interest for Parents

 

Investigators: Prof. Leanne Sakzewski, The University of Queensland, 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; Prof. Stewart G. Trost, The University of Queensland, Robert S Ware, Griffith University; Dr Rachel Toovey, The University of Melbourne; Prof. Mark Peterson, University of Michigan, Michigan, USA; Megan Kentish, Paediatric Rehabilitation Service, Queensland Children’s Hospital; Sean A Horan, Griffith University, Sian Williams,  Curtin University, School of Allied Health, Perth, Liggins Institute, University of Auckland, New Zealand and Joash Wei Jie Ng, Kendang Kerbau Women's and Children's Hospital, Singapore.     

Active Strides-CP is supported by a National Health and Medical Research Council Clinical Trials and Cohort Study grant (NHMRC 2006867) Aus$2.4M

Project members

Professor Leanne Sakzewski

Conjoint Professor of Allied Health
School of Health and Rehabilitation Sciences, The University of Queensland and Children’s Health Queensland

Professor Roslyn Boyd

Scientific Director of Queensland Cerebral Palsy and Rehabilitation Research Centre
Child Health Research Centre, The University of Queensland