NHMRC - Building a HEALTHY AUSTRALIA

What is the research project about?

This project is for children and teenagers with moderate to severe cerebral palsy (CP) aged between 5 and 15 years who have difficulties with movement on both sides of their body (bilateral CP). We are trying to see if a new rehabilitation approach, called ACTIVE STRIDES-CP will improve children’s gross motor skills, and physical activity at home. The approach combines a package of walking training using treadmills, overground walking using assistive devices, cycling and practice of gross motor goals with a total of 32 hours of therapy provided over an eight-week period.

Unfortunately, most of the existing evidence for effective therapies are for children with cerebral palsy who can walk without assistive devices. As much less research has been conducted in children with cerebral palsy that rely on physical assistance and equipment, this research will focus on this much needed area.  We are looking to see if Active Strides-CP can help children better achieve their gross motor goals, improve their mobility around home and adaptive cycling in their community.

Who is funding the research project?

This study is funded by a project grant from the National Health and Medical Research Council (NHMRC) APP2006867. As such, there is no cost to you.

Who is eligible to participate in this study?

To be eligible, children must:

• Be aged between 5-15 years of age 
• Have a diagnosis of CP and experiences difficulties with movement of both legs and one or both arms
• Be classified using the Gross Motor Function Classification System as beling levels III or IV.
• Have goals to improve mobility, cycling, sit-to-stand or stepping transfers;
• Be able to attend training, testing and follow-up sessions;
• Be able to understand instructions and complete all the tests
• Not have had any orthopaedic or neurosurgical surgery in the 12 months prior to the study period
• Be medically fit to undertake moderate intensity exercise; 
• Have adequate range of motion in their hips, knees and ankles to ride a specially designed cycle/bike;
• Be able to verbally or nonverbally communicate pain or discomfort.

Children who have the following characteristics are not eligible:

• Has epilepsy uncontrolled by medication
• Has had surgery, trauma or fractures in the preceding 12 months and does not have medical clearance to participate;
• Has a cardiovascular or pulmonary disease and does not have medical clearance 

What is involved in the study?

Because we need to compare the new therapy to something else, we have 2 groups. One group gets the therapy right away (NOW), and one group gets put on a wait-list (WAIT). Families who are on the wait-list will still get to have the therapy at the end of 6 months of waiting. By having one group who receives ACTIVE STRIDES-CP and one group who continues with routine regular therapy, this will help us to understand whether ACTIVE STRIDES-CP leads to better outcomes than usual care.

The main things involved are:

• Being in the study for between 6 and 9 months
• Coming to the research/therapy centre 2 x weekly for therapy sessions (1.5hrs each)
• Having the therapist come to your house every fortnight for 4 visits to do therapy at home (1 hour each)
• Having the therapist contact you for a telehealth session on the alternate weeks to home visits for 4 sessions (1 hour each)

Because it is for research, we ask you and your child to do more things than you would do if you were getting this therapy in a normal way. These extra things include:

• Filling out surveys at the beginning, middle (9 weeks) and end (26 weeks) of the study. These surveys can take between 30 and 90 minutes to complete each time
• Your child wearing an activity tracker around their waist at the beginning, middle (9 weeks) and end (26 weeks) of the study. They must wear it for 7 days straight each time
• Committing to attend as many of the appointments as possible (but we will work around your availability and make it as easy as we can for you)