None listed
Conditions
Brief summary
Non-ambulant children with cerebral palsy experience more sedentary behaviour, spending up to 96% of their waking day sitting. With limited evidence-based interventions available, this can have a devastating impact on health and well-being. CPMovetime aims to develop new interventions that reduce sedentary behaviour to improve health outcomes.
Interventions
The efficacy of CP-Movetime will be evaluated using a single case experimental design (SCED) featuring concurrent, randomised, replication multiple-baseline design across participants with cerebral palsy, aged between 5 and 17 years with severe motor impairments (i.e. Gross Motor Function Classification System (GMFCS) levels IV and V). The phases will include A and B (where A is the baseline and B is the intervention). The study will be conducted and reported as outlined in the Single Case Reporting Guidelines in Behavioural Interventions (SCRIBE) 2016 statement. According to the TIDieR: Why (rationale, theory and goal of elements of the intervention): Non-ambulant children with cerebral palsy (CP) experience more sedentary behaviour, spending up to 96% of their waking day sitting. With no evidence-based interventions available, this can have a devastating impact on health and well-being. With the current recommendations for physical activity being 3 sessions a week for 8 consecutive weeks, CPMovetime aims to develop new interventions based on this dosage to provide opportunities for meaningful and safe physical activity and reduce sedentary behaviour for better health outcomes in children with cerebral palsy. What (is needed for intervention delivery): An ellipitcal trainer, hoist - to enable partial body weight support over the trainer, heart rate monitor and engagement materials such as adapted visual materials and adapted video games. What (procedures and activities used in the intervention): Each session will by 1 hour in duration and consist of 2, 10 minute sessions on an elliptical trainer. The child or participant will be supported with a harness to enable them to be safely upright with partial body weight support. The elliptical trainer will enable passive movements of the legs and will be powered through the arm holds by the therapist to ensure appropriate speed and direction. The aim is not to attain a specified speed, rather, given the varying effects of lower limb spasticity or dystonia, the aim will be to maintain consistent and slow movement whilst ensuring the participant is comfortable with no resisting of movement. Between the sets and after the 2nd set, participants will engage in a standing activity for 10 minutes. This may include engagement in an adapted video game (Nintendo Switch utilising the Horii Flex controller for switch adapted games - already commercially available) or gross motor activities such as kicking a ball or bowling. Who will provide the expertise: Each session will involve a team of 3 therapists (combination of physiotherapist, occupational therapist and therapy assistant) which is required for the transfer. How (modes of delivery): Individual sessions Where (location): in a community-based therapy centre. When and how much (dosage): Attend 3, 1 hour sessions a week over 8 weeks. Tailoring (personalisation of intervention): All children will follow the protocol that was specifically designed for this study. However, there may be some adaptations to enable the child to complete the activity in the most efficient way. This includes taking into account preferences (for interactions, experiences and development of experiences of enjoyment and success) and positioning when upright for comfort. How well (fidelity): A manual of intervention and onsite training with credentialing sign off by the Chief Investigator. This will ensure that the intervention is provided consistently. Session adherence will be monitored by checklists which need to be completed throughout the session and recorded as a progress note. Each participant will be randomly assigned to one of three conditions: 1) Phase A (baseline) for 2 weeks, Phase B (intervention for 8 weeks); 2) Phase A (baseline) for 4 weeks, Phase B (intervention) for 8 weeks; or 3) Phase A (baseline) for 6 weeks, Phase B (intervention) for 8 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
Children with cerebral palsy, aged between 5 and 17 years classified within GMFCS levels IV and V.
Exclusion criteria
Unstable hip dislocations, orthopaedic surgery (lower limb) in the past 6 months, uncontrolled seizures.