Title: 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
Funder: Health Education England

Abstract: Background: Children with cerebral palsy (CP) present with multiple impairments, such as muscle weakness and poor postural control that affect their development of movement. These impairments lead to limitations in walking and balance that affect a child's self-esteem and ability to integrate with their peers. The causes of specific walking deficits are multifactorial. As such, previous studies have found that targeting one impairment in isolation leads to limited improvements in function. This is compounded by the fact that children find it hard to train at the correct frequency, intensity and in functional positions such as upright standing. These issues may be potentially addressed and improved by using a novel interactive trainer that uses motors at the ankles and knees to appropriately resist or assist movement while the child is standing. Sensory feedback about applied force and movement are integrated into age-appropriate computer games that the child controls. This aids adherence whilst achieving the required frequency and intensity of training. Aim: To establish the feasibility of undertaking a Randomised Controlled Trial (RCT) to assess the clinical effectiveness of the interactive trainer and the impact on the lived experience and adherence to therapeutic exercise programmes by children with CP and their families. Participants will be children with CP aged 8-18 years who have mobility at the levels I-III as described by the Gross Motor Function Classification Scale (GMFCS). Design: The project has four parts: Establishing the measurement properties of a novel measure of postural control when stepping. Inter- and intra-rater reliability will be tested in 25 children with CP and analysed using Intra-Class Correlation Coefficients and Bland Altman plots. Two raters will assess the children on two occasions. Comparisons to typically developing children will be used to investigate concurrent validity. Establishing usual care. This will use a nominal group technique with 8-12 expert paediatric physiotherapists. Feasibility RCT. Ambulant children with CP (n=40, Age 8-18 years, GMFCS I-III) will be allocated to an interactive trainer group or a usual care group (home and school based exercises). Minimisation will balance groups for age and symptom severity. Training will occur over ten weeks. Measures of walking and balance ability will be made at baseline, 10 and 22 weeks post-baseline. Daily electronic diaries will record adherence and children's views on exercising. Data with be summarised using descriptive statistics and CONSORT diagram and inform a definitive trial. A qualitative study will be conducted to understand children's, parents' and physiotherapists' views on the trial. Data generation with the children will be undertaken using semi-structured interviews incorporating a photo-elicitation method. Twelve children from the control group (n=6) and intervention group (n=6) and across the range of severities will be given electronic tablets and asked to record a diary and take 5-20 photos to represent their experiences of their exercise programme. This will then guide the discussion during the interview at the end of week 10. The interviews will explore their views on the trial as well as factors affecting adherence to exercise. Data generation with parents of the children (n=12) and physiotherapists (n=4) will be undertaken using semi-structured interviews to explore their views on trial feasibility. Decliner and withdrawer interviews will be undertaken where possible. Data will be transcribed and analysed thematically using triangulation with the diary entries. Expected outcomes: Feasibility will be assessed in terms of recruitment and dropout rates; adverse events; percentage of outcomes completed, participant adherence and fidelity of treatment delivery. Interviews with children and parents and therapists will explore issues associated with participating in the study and factors affecting adherence with exercise. This will aid the final design delivery of a future fully powered RCT.

Lay abstract: Children with cerebral palsy (CP) frequently have difficulties walking. Walking can be very tiring and difficulties with balance makes everyday tasks much harder. This can impact on a child's self-confidence and how children interact with other peers. Home exercise programmes are designed to help with such problems but children often don't want to do these exercises. When a child's muscles get stiff and tight they may need costly and burdensome surgery to lengthen the muscles. Where there are several problems that affect movement, it can be difficult for physiotherapists to develop effective home-based treatments. 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. It is important to demonstrate greater effectiveness of new treatments such as this interactive trainer against usual care before introducing it for routine use in the NHS. This current study will be preliminary work to find out if it is possible to undertake a major study to test the effectiveness of this intervention. Children with CP who are able to walk will be recruited through their physiotherapists and other networks. 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 a long 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. The mat will then be tested to see if it can distinguish between the balance of typically developing children and children with CP. 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 20 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. The content of the usual care exercises will be defined and based on current guidelines and the consensus opinion of ten expert physiotherapists. 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 receive 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. I will interview a group of physiotherapists about their experiences of the study. The results from this study will be brought together to determine how to design future clinical trials.

Research activity codes: 6.7 PHYSICAL
Health categories: NEUROLOGICAL