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Active Start Active Future: a randomised control trial of an early behaviour-change intervention targeting physical activity levels in young children with cerebral palsy

Active Start Active Future: a randomised control trial of an early behaviour-change intervention targeting physical activity participation and sedentary behaviour in young children with cerebral palsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000042549
Enrollment
19
Registered
2024-01-18
Start date
2024-04-10
Completion date
2025-11-04
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Children with cerebral palsy (CP) participate less in physical activity and have high levels of sedentary behaviour compared to children without CP. In this research we will conduct a mixed methods randomised controlled trial called Active Start Active Future with families who want to support their child’s physical activity participation and consider their own physical activity. We are aiming to determine whether Active Start Active Future is effective in changing the amount of physical activity, physical activity participation and reduce sedentary time for the child at home, in the community, preschools and schools. We will ask parents about their understanding and beliefs around physical activity and sedentary behaviour for their child with CP, explore the parents’ own physical activity behaviours, and explore ways they can support their child be more active. Our aim is to recruit 40 children aged 3-7 years with CP in Gross Motor Function Classification System (GMFCS) levels II-V inclusive of children who need gait aids for mobility or do not walk. We will conduct a physical activity behaviour-change intervention once a week, for 8 weeks face-to-face (with telehealth opportunities if requested). Our trial is innovative because it intervenes earlier in the development of sedentary behaviour and will be one of the first studies to include children who cannot walk independently. The intervention is grounded in evidence-based theories of health behaviour change, individualised for each family, and will be delivered by a paediatric physiotherapist or occupational therapist. Anticipated benefits include gaining a greater understanding of physical activity participation in young children with CP and mechanisms to help change behaviours.

Interventions

Active Start Active Future is a participation focused physical activity (PA) intervention that promotes being active through behaviour change strategies. The intervention moves away from a more traditional therapy hands on approach to an approach driven by the child's and parents preferences to participate. The strategies identify barriers to being active and focuses on facilitators to help the child and their family increase participation in their preferred physical activities. We aim to recru

Active Start Active Future is a participation focused physical activity (PA) intervention that promotes being active through behaviour change strategies. The intervention moves away from a more traditional therapy hands on approach to an approach driven by the child's and parents preferences to participate. The strategies identify barriers to being active and focuses on facilitators to help the child and their family increase participation in their preferred physical activities. We aim to recruit 40 young children with cerebral palsy (CP) (20 immediate intervention and 20 wait list). All wait list children will receive the intervention at 6 months. Children with CP who mobilise at Gross Motor Functional Classification System Level II - V (use a rail for stairs and less balance on uneven ground to full support needed) will be invited to participate. All children recruited will receive one-hour weekly sessions for 8 weeks. Parents/main carer will also be participants, with collection of their physical activity and sedentary physical activity levels via questionnaire and a qualitative exploration of their physical activity views and motives. Sessions will be delivered in location of choice: family home, pre/school or community. All sessions will be conducted by a qualified physiotherapist, and the child and at least one parent/carer will attend each session. Treatment notes will be written after each session (record of attendance and session content) and any correspondence between sessions such as planning, ordering of equipment, and sharing of information will be recorded on a secure RedCap database. Usual care diaries will also be kept by families and recorded on RedCap also.. Active Start Active Future will share a similar theoretical framework and delivery mode with participation-focused therapy, Participate-CP for older children with CP (8-12 years) and feasibility study in 2020 for the younger age group. The design includes motor learning and targeted training of skills to assist with physical performance goal attainment. The framework supports participants’ basic psychological needs for autonomy, competence and relatedness according to Self-Determination Theory. Active Start Active Future will facilitate more intrinsic types of motivation by supporting children to achieve 2-3 self-identified PA behaviour goals - encouraging increased participation in PA and increasing skill development of one physical goal for the child. Each parent/carer will also set 2 participation goals that focus on their ability to support their child’s behaviour change. For example, a child's participation goal may be to attend swimming 1x/week and to enjoy swimming. The parents goal may be to make time to attend swimming and support their child in the pool. The physical goals may be for the child to float on their back for 3 seconds. 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). Children will be assessed at baseline T1, end of intervention T2 and at follow up T3 (6 months following baseline) to determine any sustained changes as a result of the intervention. The wait list group will begin the intervention at T3 and complete the 8 weeks at T4. Children are able to participate in any of the regular therapies and physical activities.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
3 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Children will be included (a) who have been diagnosed with CP functioning at GMFCS levels II-V, (b) are between 3.00-7.99 years, (c) have at least one primary caregiver that can also participate, and (d) have a primary residential address within 130km of South Brisbane, QLD, (e) if this is the sole therapy intervention study they are enrolled in. Adults will be included who (a) are primary parent/carer of the child enrolled, Additional adults who are significantly involved with the child’s physical activity participation may be enrolled for the qualitative interviews only if they (b) support the intervention in the community (community therapists, community members e.g., coaches), or (c) support the intervention at pre school, kindy, school (school therapists, education and child care staff).

Exclusion criteria

Children will be excluded if the child: (a) has orthopaedic and/or neurological surgery within 6 months prior to baseline or planned during the study period, (b) has uncontrolled epilepsy and/or medical fragility (c) is already participating in a therapy intervention study No maximum age for adults. Adults can be healthy volunteers

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026