None listed
Conditions
Brief summary
Children with cerebral palsy (CP) participate less in physical activity and have high levels of sedentary behaviour (sitting still) compared to children without CP. Our aim is to pilot a physical activity behaviour-change intervention in 12 children with CP under eight years old. Our trial is innovative because it aims to intervene earlier in the development of sedentary behaviour and will be the first to include children who cannot walk independently. The intervention is grounded in evidence-based theories of health behaviour change. The 8 week face-to-face, highly tailored intervention will be delivered by a paediatric physiotherapist or occupational therapist, with the aim to increase participation in community physical activities and reduce sedentary behaviour. It is important that we pilot some of the outcome measures to be used in the trial including accelerometers, because we don’t have good information about their ability to detect change in this population. Anticipated outcomes of this project will include: information about the feasibility and tolerability of the intervention and outcome measurement; pilot evidence of how effective the therapy is; and information about the behaviour-change mechanism of the intervention.
Interventions
Active Start Active Future is a paediatric physiotherapy/occupational therapy intervention using existing and well-established and evidence-based therapeutic tools. These tools include: goal-setting, motivational interviewing and empathetic listening, provision of information, provision/prescription of assistive technology, communication with stakeholders, goal-directed functional motor training of sport-specific skills, and action planning.
The intervention utilises a process of clinical reas
Active Start Active Future is a paediatric physiotherapy/occupational therapy intervention using existing and well-established and evidence-based therapeutic tools. These tools include: goal-setting, motivational interviewing and empathetic listening, provision of information, provision/prescription of assistive technology, communication with stakeholders, goal-directed functional motor training of sport-specific skills, and action planning. The intervention utilises a process of clinical reasoning whereby: (1) ~3 goals about increasing physical activity participation and/or reducing sedentary behaviour are set collaboratively together, (2) modifiable barriers to change in the goals are identified, then (3) these barriers are matched with tool/s utilised by the therapist to help overcome those barriers. This process has already been tested in children with cerebral palsy 8-12 years old who can walk. The intervention involves 8 sessions of 1 hour duration of face-face contact with a therapist over an 8-week period (i.e. once per week). The child and adult/caregiver both attend all 8 sessions together. The intervention is delivered by a trained paediatric physiotherapist or occupational therapist. The therapist provides sessions within the child's home, community and/or education setting (i.e. natural settings associated with daily life and recreation). Compared to a similar intervention applied in older children, Active Start Active Future is adapted to young children with cerebral palsy by a greater focus on adults (e.g. caregivers, teachers, community members) around the child who can influence the child's physical activity behaviours. Regarding intervention fidelity, therapists must attend ~14 hours of training prior to delivering the intervention and will have access to a manual. During the active intervention phase, therapists will have a videoconference meeting once per month facilitated by the Study Coordinator or representative. Therapists can discuss case studies, clinical reasoning, problems/concerns and calibrate their delivery of the intervention so that consistency is maintained across the trial sites. Therapists will complete a clinical reasoning grid for each child receiving the intervention to support and justify the choice of therapeutic techniques. In order to report fidelity information alongside the results of the trial, an independent rater who is experienced with the family of Participation-related Constructs will review all COPM goals for consistency with the “attendance” and/or “involvement” constructs. All intervention sessions will be videotaped in order to enable a random sample of sessions to be analyzed for content and alignment with written information at the conclusion of the study.
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
Children are included if (a) they have been diagnosed with cerebral palsy and are functioning at GMFCS I-V, (b) are between 4.00-7.99 years at baseline, (c) have at least one primary caregiver that can also participate, and (d) have a primary residential address within 150km of South Brisbane, QLD.
Exclusion criteria
Children are excluded if they (a) had orthopaedic and/or neurological surgery within 6 months prior to baseline or have planned during the study period, (b) have uncontrolled epilepsy and/or medical fragility, and/or (c) have a caregiver with English language skills not sufficient to understand the study information, provide informed consent and/or complete study questionnaires. Participants at GMFCS IV and V must already own a standing device (or be able to acquire one quickly) due to the limited timeframe available (the study must be complete by December 2020).
Outcome results
None listed