Preschool HABIT-ILE: A randomised controlled trial to determine efficacy of intensive rehabilitation compared to usual care to improve motor skills of children, aged 2 to 5 years, with bilateral cerebral palsy.

Do you have a child aged 2 years to 5.5 years with bilateral cerebral palsy (GMFCS II-IV)?

Call or email us to find out if your child can participate in this research study!

About the study

This project is for young children with cerebral palsy (CP) aged between 2 and 5 years who have difficulties with movement on both sides of their body (bilateral CP). We are trying to see if a particular intensive therapy called Hand Arm Bimanual Intensive Training Including Lower Extremity Training (HABIT-ILE) can help to improve hand and gross motor skills.

This is a waitlist randomised controlled trial. That means that your child will have a 50% chance of receiving HABIT-ILE immediately OR continue with their routine regular therapy program for six months and then receive HABIT-ILE. If your child is randomised to the group that will continue to receive their regular routine therapy, they will still come for assessments. We don’t know if Preschool HABIT-ILE will be any better than routine regular therapy. By having one group who receives Preschool HABIT-ILE and one group who continues with routine regular therapy, this will help us to understand whether Preschool HABIT-ILE leads to greater outcomes.

What does the study involve?

If you agree to be in the study, there are a number of steps:

Before the therapy, your child will complete a number of tests and we will get you to do some questionnaires. There will be another appointment one to three weeks after Pre- school HABIT-ILE to complete the assessments again. We will do a final assessment six months following Preschool HABIT-ILE to determine whether any improvements from the intervention and kept in the longer term. If your child is randomised into the waitlist group, they will receive HABIT- ILE after their 6 month assessment and then do the assessments once more one to two weeks after the camp.

Preschool HABIT-ILE runs over 2 weeks. Your child will come to a group every day from Monday to Friday for 3 hours in the morning. There will be a minimum of one therapist/therapy student working with your child. There will be supervising therapists who have extensive experience in working with children with CP and have been trained as supervisors for Preschool HABIT-ILE. They will be supervising and mentoring volunteer therapists/therapy students who will work directly with your child.

Each day, we will also provide you with a small number of activities to practice at home.

We want to improve our ability to measure improvements in your child’s gross motor skills, use of both hands together, and their physical activity. To do this, we need your child wear small devices with sensors inside.

We will ask your child to wear the devices:

1. During all assessments
2. During the camp

What are the benefits to participating in this study?

Benefits to you:

If your child receives Preschool HABIT-ILE it may help improve his/her hand and gross motor skills. Irrespective of the group your child is allocated to, he/she will continue to receive their usual therapy care and will receive HABIT-ILE, either immediately or after a 6 month waitlist period.

Benefits to others:

If we show Preschool HABIT-ILE is helpful, then occupational therapists and physiotherapists working with other children with bilateral CP to improve their hand and gross motor skills can use it.

Recruitment criteria

Participants must:

• Between 2–5.5 years of age
• Live in Brisbane
• 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 levels II, III or IV
• Be able to grasp light objects and lift their most impaired arm 15 cm above a table surface
• Be able to understand instructions and complete all the tests
• not have epilepsy uncontrolled by medication
• not have had any orthopaedic surgery in the six months prior to the study period
• not have difficulties with vision that interfere with treatment and tests

Would you like more information?

Contact Details:
If you would like to take part in this study, or have questions and would like more information, please contact our Chief Investigator: A/Prof. Leanne Sakzewski, Ph: +61 7 3069 7345 or E: l.sakzewski1@uq.edu.au (Mon-Fri)

This study adheres to the Guidelines of the ethical review process of The University of Queensland and the National Statement on Ethical Conduct in Human Research. Whilst you are free to discuss your participation in this study with project staff, if you would like to speak to an officer of the University not involved in the study, you may contact the Ethics Coordinator on (07) 3365 3924.

Ethics approval identifier: Ramaciotti Foundation Health Investment Grant (2019HIG/043)

Funding source: Ramaciotti Foundation

Grant Type: Health Investment Grant

Chief Investigators

A/Prof. Leanne Sakzewski, Dr Sarah Reedman, Ms Kate McLeod, Ms Megan Thorley,  Mrs Andrea Burgess, Prof. Stewart Trost, Mr Matthew Ahmadi, Dr David Rowell, Prof. Yannick Bleyenheuft, Prof. Roslyn Boyd.