A novel interactive training device to improve walking Ability and quality of life for Children with CErebral Palsy Trial (ACCEPT study)

A multi-centred feasibility RCT with an embedded qualitative study

Background

Children with cerebral palsy (CP) frequently have difficulties walking. Walking can be very tiring and difficulties with balance make everyday tasks much harder. This can impact on a child’s self-confidence and how children interact with peers.

The ACCEPT study will compare a novel fun intervention aimed at improving walking and balance, with usual physiotherapy care.

Rachel Rapson is the lead researcher for this study. She is an experienced children’s physiotherapist and is also undertaking a Clinical Doctoral Fellowship funded by the National Institute of Health Research (NIHR).

A child using the dynamic interactive trainer

A novel piece of equipment, similar to a cross-trainer, has been developed that allows the child to do therapy by playing motivating computer games, using their leg movement. 

The device supports the child in a standing position, while they work on improving standing posture, balance, strength and mobility in a fun and motivating way. The device uses motors at the ankles and knees to assist or resist the movements that children have difficulties performing. It allows children to carry out precise movements to control a series of interactive, fun computer games. A small study suggested that using the interactive trainer intensively over a 10 week period results in some improvement in children’s walking. 

However, it is a costly device and we need to know whether it really improves walking and balance and the child’s experience of doing physiotherapy.

The ACCEPT study will aim to answer this question in three phases:

Phase 1: The Next Step Study

This study involves developing a new outcome measure which can quantify how a child coordinates balance, while taking a step. A reliable test of balance during stepping is needed to find out if the trainer helps children to improve the quality of their walking. The current gold-standard test takes along time and relies on costly gait laboratory equipment. The new test will involve standing onto different targets, using a specialised mat with sensors on the body. The reliability of the test over time and between different testers will be explored. It will also be tested to see if it can distinguish between the balance of typically developing children and children with CP.

Recruitment will take place from February 2019 until July 2019. 


50 children will be recruited for this study across Devon and Cornwall, all aged between 8-18 years. This will include 25 children with CP who are able to walk at least 5 steps, and 25 children with typical motor development.

Next step test

Phase 2: Defining Usual Care

It is necessary to standardise the ‘usual care’ given to the control group in a clinical trial. Usual care may vary between clinicians across Devon and Cornwall. This study aims to bring together local expert physiotherapists to define usual care and then to compare with a similar group in the South East of the UK. This aims to ensure that we reflect national practise. The content of the usual care exercises will be defined by a nominal group during a forum meeting held in Plymouth and another held in Greater London. The resulting usual care package will be based on current guidelines.

Recruitment will take place from March 2019 until August 2019.

5-12 Paediatric Community Physiotherapists from Devon and Cornwall and 5-12 Paediatric Community Physiotherapists from South East England

Phase 3: Feasibility Randomised Controlled Trial

A small study will then be undertaken to see if it is feasible to run a larger trial. Children with CP will be allocated at random, using a computer, to either a group using the interactive trainer or usual physiotherapy management. This will ensure both groups are similar in terms of the age and level of physical impairment at the start of the trial. 

Twenty children will use the interactive trainer and twenty children will have usual care. The interactive trainer will be based at a local school or physiotherapy department and set up to the individual child’s training needs by their physiotherapist. Children will then train 3 times per week, helped by their physiotherapy or teaching assistant. The ‘usual care’ group will undertake home-based exercises. Training in both groups will take place over ten weeks. Children will be assessed at the beginning of the study, after ten weeks of therapy, and three months after finishing the training.

Measures will include walking and balance ability, and other factors such as strength and overall satisfaction. The results of this study will tell us whether it is feasible to run a large trial to test whether the interactive trainer is more effective than usual care.

Finally, participants’ views will be sought on whether the novel intervention and the usual care exercises were comfortable and motivating. Six children and their parents from each group will be selected and invited to be interviewed. These children will borrow an electronic tablet and will be asked to indicate daily how they found the training and how they felt. Over the ten week training period they will be asked to take 5-20 photos that they feel represent their experiences of their exercise programme. The photos will guide the discussion during an interview to gain a deeper knowledge of their experiences. Parents will also be interviewed about the impact of the exercise programme on family life as well as the feasibility of this study. 

The Physiotherapists involved will be interviewed about their experiences of the study. The results from this study will be brought together to determine how to design future clinical trials.

Recruitment will take place from April 2020 until March 2021.

40 children aged 8-18 years who have CP and who can walk will be recruited across Devon and Cornwall.

A child using the dynamic trainer