ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000255987

Ethics application status

Approved

Date submitted

10/02/2020

Date registered

26/02/2020

Date last updated

10/05/2021

Date data sharing statement initially provided

26/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Active Start Active Future: an early behaviour-change intervention to reduce sedentary behaviour and promote physical activity in young children with cerebral palsy

Scientific title

A pilot study of a participation-focused, health behaviour-oriented approach to physiotherapy/occupational therapy to reduce sedentary behaviour and promote physical activity participation in children with cerebral palsy ages 4-7 years

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1247-9952

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cerebral palsy

sedentary behaviour

physical inactivity

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Physiotherapy

Physical Medicine / Rehabilitation

Occupational therapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Rehabilitation

Intervention code [2]

Behaviour

Intervention code [3]

Lifestyle

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Tolerability, including: attendance/non-attendance at sessions, accelerometer device wear/non-wear (accelerometers are described below in secondary outcomes), adverse or unintended effects, and child enjoyment (self-rated 1-5 with matching faces and descriptors). Reasons will be collected where possible. This is a composite primary outcome.

Examples of known or possible adverse or unintended effects include:
- skin irritation from wearing physical activity monitoring devices (accelerometers)
- injuries/illness associated with participation in physical activities including scrapes, bruises, muscle soreness, fatigue, musculoskeletal injuries
- parent/cargiver sadness, guilt or anxiety (mild) associated with discussion of upsetting topics or sensitive information
Known or possible adverse or unintended effects will be captured by standardized recording form following each intervention session.

Timepoint [1]