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Trial registered on ANZCTR

Registration number

ACTRN12618000206224

Ethics application status

Approved

Date submitted

24/01/2018

Date registered

9/02/2018

Date last updated

17/08/2023

Date data sharing statement initially provided

8/01/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

PARTICIPATE-CP: Optimising participation in physically active leisure for children with Cerebral Palsy

Scientific title

The effect of a participation-focused therapy (PARTICIPATE-CP) on participation in physically active leisure for children with Cerebral Palsy: A randomised controlled trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

PARTICIPATE-CP

Linked study record

Health condition

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

Cerebral Palsy

Condition category

Condition code

Neurological

Other neurological disorders

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Occupational therapy

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participate-CP is a targeted intervention underpinned by Self Determination Theory and using communication techniques of motivational interviewing. It is individualised and specifically tailored to the participation related goals and preferences of children and their family. This is a major paradigm shift in therapy approaches for children with CP. Participate-CP represents a departure from existing interventions tested in RCTs as it does not use a standardized intervention (e.g. standardized, non-individualized strength training with definable characteristics such as repetitions and exercise techniques), found to be ineffective to increase physical activity participation in this population. Participate-CP is a model of pragmatic participation-focused therapy utilising a toolbox of evidence-based strategies. A key feature of Participate-CP is the use of clinical reasoning based on key factors, which likely differ substantially between participating parent-child dyads. These factors include the: (i) choice of participation goals; (ii) identification of barriers and facilitators to participation in physically active leisure; (iii) acknowledgement of child-family-environment-activity-participation interactions and; (iv) stage of parent-child dyad physical activity behaviour change. Essential elements of Participate-CP include:

1. Goal directed, individualised and family-centred:
Two to three participation goals (e.g. horseback riding once per week in the community) are first identified by the child and parent. The therapist then explores with the child and family the potential barriers/limiting factors and facilitators to the participation goals (e.g. equipment requirements, community attitudes, child factors).

2. Ecological:
The intervention is delivered individually in the child’s home, school, community environment as relevant to each participation goal by a physiotherapist, occupational therapist, or exercise scientist, trained in the use of Motivational Interviewing and coaching.

3. Multifaceted intervention strategies:
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).
Therapists will video-record all intervention sessions for central monitoring of content and fidelity across sites.

Intervention is delivered as weekly one hour sessions over 12 weeks. The first and last weeks involve goal setting and measurement. Children will continue to receive usual care throughout the trial period. Usual care will be highly valuable both within and across participating sites. Caregivers will complete a usual care diary that records the number of hours per week their child accessed (rounded up to the nearest hours) of each of the following therapies:
• Physiotherapy
• Occupational Therapy
• Speech/Language Therapy
• Exercise Physiology/ Exercise Therapy
• Psychology/ Counselling

Caregivers will be asked to report any episodes of Botulinum Toxin-A injections (site/s, date/s), and casting/splinting for hypertonicity/contracture management until follow-up assessment (intervention group) or the end of the intervention (wait-list- group). Usual care will be compared between intervention and wait-list participants,

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

Both the Participate-CP and waitlist group receive usual care throughout the trial period. Usual care will be highly variable both within and across participating sites. Caregivers will complete a usual care diary that records the number of hours per week their child accessed (rounded up to the nearest hour) of each of the following therapies:
• Physiotherapy
• Occupational Therapy
• Speech/Language Therapy
• Exercise Physiology/ Exercise Therapy
• Psychology/ Counselling

Caregivers will also be asked to report any episodes of Botulinum Toxin-A injections (site/s, date/s) and casting/splinting for hypertonicity/contracture management (site/s, date/s). Participants will complete the diary from the first assessment until follow-up assessment (intervention group) or the end of the intervention (wait-list group). Usual care will be compared between intervention and wait-list participants.

Waitlist: 26 weeks

Control group

Active

Outcomes

Primary outcome [1]

Canadian Occupational Performance Measure (COPM) performance with physically active leisure participation goals

The COPM will be used to measure performance of individually defined physically active leisure participation goals. Test retest reliability is high (ICC 0.76-0.89) and the COPM is responsive to change. To ensure that goals reflect the participation construct and not the activity domain of the ICF, the Family of Participation-Related Constructs will be employed to frame goals in terms of frequency of attendance and/or involvement. Two to three COPM goals will be set at baseline and scored at 12 weeks. A further two to three goals will be set at 12 weeks and scored at 26 weeks if the original goal/s have been achieved to the satisfaction of the child and caregiver. New goals can also be set within the intervention period (0-12 weeks) if original goals are achieved to the satisfaction of the child and their caregiver.

Timepoint [1]

Immediately post completion of the first session of the 12 week intervention (week 12, primary timepoint) and 26 weeks post-completion of the first intervention session.

Primary outcome [2]

Daily time spent in Moderate to Vigorous Physical Activity

ActiGraph GT3X+ will be worn on the hip for seven consecutive days. Activity counts will be transformed via the GMFCS-specific cut-points developed by CIF to time spent in sedentary behaviour, light and MVPA. These cut-points were shown to substantially reduce misclassification error among youth with more severe motor impairments; and provided more accurate assessments of physical activity intensity than previously published validation using cut-points for children and adolescents with CP. A wear time of seven days is required to achieve maximum validity in this population. Caregivers complete a logbook to record the child’s activity and position throughout each day of wear to perform validation of the data if required. Children will be offered a standard elastic belt for wearing the device on the waist and a neoprene cover if required for comfort.

Timepoint [2]

Immediately post completion of the first session of the 12 weeks intervention and 26 weeks post-completion of the first intervention session.
Primary timepoint is at 12 weeks.

Primary outcome [3]

Canadian Occupational Performance Measure (COPM) satisfaction with physically active leisure participation goals

The COPM will be used to measure satisfaction with individually defined physically active leisure participation goals. Test re-retest reliability is high (ICC 0.76-0.89) and the COPM is responsive to change. To ensure that goals reflect the participation construct and not the activity domain of the ICF, the Family of Participation-Related Constructs will be employed to frame goals in terms of frequency of attendance and/or involvement. Two to three COPM goals will be set at baseline and scored at 12 weeks. A further two to three goals will be set at 12 weeks and scored at 26 weeks if the original goal/s have been achieved to the satisfaction of the child and caregiver. New goals can also be set within the intervention period (0-12 weeks) if original goals are achieved to the satisfaction of the child and their caregiver.

Timepoint [3]

Immediately post completion of the first session of the 12 weeks intervention and 26 weeks post-completion of the first intervention session.
Primary timepoint is at 12 weeks.

Secondary outcome [1]

Goal attainment measured using Goal attainment Scaling (GAS) which looks at frequecy, intensity, diversity, capacity and/or independence of overarching participation goal

Goal Attainment Scaling (GAS) is an objective method of quantifying goal attainment. Goals are scored on a likert-type scale from -2 (representing no positive change at all from baseline / regression), -1 (a little less change than expected), 0 (attainment of goal at the expected level), +1 (a little more change than expected), to +2 (attainment of goal at much more than the expected level). Goals will be personally important to the individual (rather than standardized) with the distance between each increment representing a relatively equal amount of effort or improvement to achieve. Each goal will describe an element of participation, linked to the participant’s primary COPM goal, such as frequency, intensity, diversity, or assistance required. Goals will be set collaboratively mid-intervention (rather than at the same time at COPM goals in the first session) as some change in goal content is expected due to the iterative nature of the process. As goal-setting forms an integral part of the intervention, the wait-list control group will not set GAS goals until they undertake their own intervention period and GAS scores will be analysed as paired samples (within groups). A summary score will be calculated into an aggregate T-score.

Timepoint [1]