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.