None listed
Conditions
Brief summary
In Australia, 35,000 people are living with cerebral palsy (CP). People with CP have poorer health outcomes, are less active and have a 1.2 to 1.6 greater risk of chronic health conditions such as diabetes, hypertension and stroke compared with those without a disability. We have promising data about a new intervention called Participate-CP, which is a therapy that improves children’s participation in physical activity goals that are meaningful to them. In this trial for 100 children with CP, we will compare Participate-CP to Standard Care to see whether or not the intervention delivers additional benefits over Standard Care.
Interventions
Participate-CP is a targeted intervention underpinned by Self Determination Theory and using communication techniques of motivational interviewing. It is individualised and specifically tailored to the participation related goals and preferences of children and their family. This is a major paradigm shift in therapy approaches for children with CP. Participate-CP represents a departure from existing interventions tested in RCTs as it does not use a standardized intervention (e.g. standardized, non-individualized strength training with definable characteristics such as repetitions and exercise techniques), found to be ineffective to increase physical activity participation in this population. Participate-CP is a model of pragmatic participation-focused therapy utilising a toolbox of evidence-based strategies. A key feature of Participate-CP is the use of clinical reasoning based on key factors, which likely differ substantially between participating parent-child dyads. These factors include the: (i) choice of participation goals; (ii) identification of barriers and facilitators to participation in physically active leisure; (iii) acknowledgement of child-family-environment-activity-participation interactions and; (iv) stage of parent-child dyad physical activity behaviour change. Essential elements of Participate-CP include: 1. Goal directed, individualised and family-centred: Two to three participation goals (e.g. horseback riding once per week in the community) are first identified by the child and parent. The therapist then explores with the child and family the potential barriers/limiting factors and facilitators to the participation goals (e.g. equipment requirements, community attitudes, child factors). 2. Ecological: The intervention is delivered individually in the child’s home, school, community environment as relevant to each participation goal by a physiotherapist, occupational therapist, or exercise scientist, trained in the use of Motivational Interviewing and coaching. 3. Multifaceted intervention strategies: Strategies are targeted to the unique and modifiable barriers to participation for each child will include a combination of: (a) Motivational interviewing strategies used earlier and to a greater extent with dyads who have not yet started thinking about participating in more physical activity; (b) Equipment prescription or loan where access to appropriate equipment is an identified barrier to participation; (c) Cognitive-orientation approaches to motor learning and skill performance used with participants with high motivation to attain a specific skill, and where the lack of skill is a barrier to internally motivated, self-determined participation; (d) Solution-focused problem solving where behavioural strategies such as action planning, scheduling and monitoring (may be appropriate solutions for beginning and maintaining participation or overcoming environmental barriers). Therapists will video-record all intervention sessions for central monitoring of content and fidelity across sites. Intervention is delivered as weekly one hour sessions over 12 weeks. The first and last weeks involve goal setting and measurement. Children will continue to receive usual care throughout the trial period. Usual care will be highly valuable both within and across participating sites. Caregivers will complete a usual care diary that records the number of hours per week their child accessed (rounded up to the nearest hours) of each of the following therapies: • Physiotherapy • Occupational Therapy • Speech/Language Therapy • Exercise Physiology/ Exercise Therapy • Psychology/ Counselling Caregivers will be asked to report any episodes of Botulinum Toxin-A injections (site/s, date/s), and casting/splinting for hypertonicity/contracture management until follow-up assessment (intervention group) or the end of the intervention (wait-list- group). Usual care will be compared between intervention and wait-list participants,
Sponsors
Study design
Eligibility
Inclusion criteria
(a) aged 8-14 years (b) confirmed diagnosis of CP from rehabilitation specialist; (c) Gross Motor Function Classification (GMFCS) Levels I-IV; (d) lives within 150km radius of trial sites (e) at least one parent understands written and verbal English and can speak English (information and consent materials and questionnaires will not be available in languages other than English) (f) there is a desire to work on goals around participating more often or being more involved physical activities
Exclusion criteria
(a) limited ability of child to communicate insight into preferred future (needs, wants, desires) in spoken English AND/OR through an interpreter or augmentative/alternative communication (i.e. Communication Function Classification System Levels IV-V); (b) significant intellectual disability (IQ<50); (c) uncontrolled epilepsy; (d) severe asthma exacerbated by exercise, not controlled with medication under an asthma management plan; (e) planned orthopaedic surgery 6 months prior to or throughout intervention/follow-up period (f) was enrolled and previously received the intervention in the pilot study in South-East Queensland (2016-2017)