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Trial registered on ANZCTR


Registration number
ACTRN12620000255987p
Ethics application status
Not yet submitted
Date submitted
10/02/2020
Date registered
26/02/2020
Date last updated
26/02/2020
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] 300501 0
None
Universal Trial Number (UTN)
U1111-1247-9952
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 316184 0
sedentary behaviour 316185 0
physical inactivity 316186 0
Condition category
Condition code
Neurological 314475 314475 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 314476 314476 0 0
Physiotherapy
Physical Medicine / Rehabilitation 314477 314477 0 0
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] 316807 0
Rehabilitation
Intervention code [2] 316808 0
Behaviour
Intervention code [3] 316809 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322805 0
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] 322805 0
8 weeks (immediately post-intervention) and 16 weeks (follow-up).
Primary outcome [2] 322806 0
Caregiver-perceived performance of, satisfaction with, and self-efficacy related to PA participation and sedentary behaviour change goals (Canadian Occupational Performance Measure COPM, and Belief in Goal Self-Competence Scale, BiGSS). Minimal clinically important difference for the COPM is greater than or equal to 2 points. This is a composite primary outcome.
Timepoint [2] 322806 0
8 weeks (immediately post-intervention) and 16 weeks (follow-up).
Primary outcome [3] 322807 0
Objectively measured PA behaviour over 7 days, using accelerometer devices:
a. 2 x ActiGraph GT3X+, a tri-axial accelerometer (ActiGraph LLC, Pensacola FL, USA). Sites: 1 x less-affected wrist and 1x less-affected lateral thigh). Data will be processed using both intensity threshold methods and activity recognition using machine learning algorithms to detect re-allocation of sitting to standing and increased ambulatory activity. Count-based intensity methods are validated in this population. Application in this pilot sample will enable cross-validation with ActivPAL3.
b. 1 x ActivPAL3™ a valid accelerometer that measures time spent sitting/lying, standing, sit-to-stand transitions and stepping (PAL Technologies Ltd, Glasgow, United Kingdom). Site: midline anterior of the less-affected thigh.
c. Diary data on sleep/wake time, sitting and standing, and non-wear time
Timepoint [3] 322807 0
8 weeks (immediately post-intervention) and 16 weeks (follow-up).
Secondary outcome [1] 379844 0
Caregiver-reported condition-specific quality of life (CP-QOL Child, caregiver-report).
Timepoint [1] 379844 0
8 weeks (immediately post-intervention) and 16 weeks (follow-up).
Secondary outcome [2] 379845 0
Behavioural barriers to healthy physical activity behaviours (Barriers to Participation in Physical Activities Questionnaire).
Timepoint [2] 379845 0
8 weeks (immediately post-intervention) and 16 weeks (follow-up).

Eligibility
Key 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.
Minimum age
4 Years
Maximum age
7 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
As this is a pilot study with primary aims to establish feasibility and tolerability, a formal sample size calculation has not been performed. We will aim to recruit even numbers of children across groups GMFCS I-II, III and IV-V rather than a population-representative distribution in order to determine if the intervention is feasible for children with different motor abilities. Twelve children with CP will be enrolled, with even numbers across GMFCS functional groups (I-II, III and IV-V) which will provide adequate information about the feasibility within each group.

Accelerometer data requires pre-processing prior to statistical analysis. Stata software will be utilised for quantitative analysis following processing. Participant characteristics and tolerability outcomes will be analysed and reported with descriptive statistics. Paired t-tests (or equivalent non-parametric test) will be used for quantitative analyses. A sensitivity analysis according to GMFCS group (I-II vs III vs IV-V) will be performed to enable exploration of effects according to ambulatory status.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15830 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 29273 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 304918 0
University
Name [1] 304918 0
The University of Queensland
Address [1] 304918 0
The University of Queensland, St Lucia QLD 4072
Country [1] 304918 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
ST LUCIA QLD 4072
Country
Australia
Secondary sponsor category [1] 305266 0
Hospital
Name [1] 305266 0
Queensland Children's Hospital
Address [1] 305266 0
Queensland Children's Hospital
501 Stanley Street
SOUTH BRISBANE QLD 4101
Country [1] 305266 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305325 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 305325 0
Human Research Ethics Committee
Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Level 7, 62 Graham Street
SOUTH BRISBANE QLD 4101
Ethics committee country [1] 305325 0
Australia
Date submitted for ethics approval [1] 305325 0
02/03/2020
Approval date [1] 305325 0
Ethics approval number [1] 305325 0
Ethics committee name [2] 305326 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 305326 0
The University of Queensland
ST LUCIA QLD 4072
Ethics committee country [2] 305326 0
Australia
Date submitted for ethics approval [2] 305326 0
02/03/2020
Approval date [2] 305326 0
Ethics approval number [2] 305326 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100006 0
Dr Sarah E Reedman
Address 100006 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
UQ CHRC, level 6 CCHR
62 Graham Street
SOUTH BRISBANE QLD 4101
Country 100006 0
Australia
Phone 100006 0
+61730697336
Fax 100006 0
Email 100006 0
s.reedman@uq.edu.au
Contact person for public queries
Name 100007 0
Dr Sarah E Reedman
Address 100007 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
UQ CHRC, level 6 CCHR
62 Graham Street
SOUTH BRISBANE QLD 4101
Country 100007 0
Australia
Phone 100007 0
+61730697336
Fax 100007 0
Email 100007 0
s.reedman@uq.edu.au
Contact person for scientific queries
Name 100008 0
Dr Sarah E Reedman
Address 100008 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
UQ CHRC, level 6 CCHR
62 Graham Street
SOUTH BRISBANE QLD 4101
Country 100008 0
Australia
Phone 100008 0
+61730697336
Fax 100008 0
Email 100008 0
s.reedman@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected in the trial, following de-identifcation.
When will data be available (start and end dates)?
Start: Immediately following publication.
End: No end date determined.
Available to whom?
Researchers who provide a methodologically sound proposal and appropriate data management plan.
Available for what types of analyses?
IPD meta-analysis.
How or where can data be obtained?
Data can be obtained by contacting the Principal Investigator Dr Sarah Reedman, s.reedman@uq.edu.au, +61 7 3069 7336.
What supporting documents are/will be available?
No other documents available
Summary results
No Results