Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001343796p
Ethics application status
Submitted, not yet approved
Date submitted
6/10/2022
Date registered
19/10/2022
Date last updated
19/10/2022
Date data sharing statement initially provided
19/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
CPMovetime - A wearable sensor and user interface on physical activity and sedentary behaviours in non-ambulant children and youth with cerebral palsy.
Scientific title
CPMovetime: co-designing a wearable sensor and user interface on daily physical activity and sedentary behaviours in school aged children and youth with cerebral palsy, classified within GMFCS levels IV and V.
Secondary ID [1] 307964 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow-up to ACTRN12621000506897

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 327622 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324711 324711 0 0
Physiotherapy
Neurological 324712 324712 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted in 2 main phases. The first is a co-design phase which will be followed by an implementation evaluation phase.

In phase 1, a user interface will be co-designed. The aim of this process is to engage with key stakeholders to explore their needs, experiences, and values to plan an initial design for the user interface as a resource tool to increase physical activity in non-ambulatory children with cerebral palsy (CP). To do this, we will establish a Key Stakeholder Advisory Council [Council] that will include 4 consumers (children and youth with CP, Gross Motor Function Classification System (GMFCS) levels IV and V and their parents/carers), 8 allied health professionals whom will be recruited through our partners Ability First Australia, Cerebral Palsy Alliance and The Healthy Strides Foundation provide services to children with CP in metropolitan, rural and remote Australia (combined, they represent over 1200 allied health professionals) and 4 digital technology leaders (including Digital Child's ARC Centre of excellence research group who are similarly developing digital technologies with the use of wearables to provide guidance for families, educators and technology creators for typically developing children).

Participants will be asked to attend a meeting which will be about 3 hours long. They can attend in person or over video. In this meeting, at least 2 researchers will be asking questions to a group of child and youth with CP, parents of children with CP, support workers, therapists and people involved in technology. Their answers will help us to understand what they would like to have on the user interface that will help their child to have more opportunities to move each day. We will record the meeting (both using video as well as sound) and transcribe verbatim.

The implementation effectiveness of the user-interface will be evaluated using a single case experimental design (SCED) featuring concurrent, randomised, replication multiple-baseline design across participants with cerebral palsy, aged between 5 and 17 years with severe motor impairments (i.e. GMFCS levels IV and V). The phases will include A and B (where A is the baseline and B is the intervention). The study will be conducted and reported as outlined in the Single Case Reporting Guidelines in Behavioural Interventions (SCRIBE) 2016 statement. To meet design standards of a SCED, 3 participants and at least 5 data collection points will be collected within each phase and site. To enhance the generalisability, involvement of primary allied health practitioners across Australia, each SCED will also be replicated across 2 other sites (each with 3 participants). Each round of SCEDs therefore involves 9 participants and with 2 rounds of replication to refine the user interface features, we will require 27 participants in total. Implementation effectiveness and refinement of the user interface will occur after each round of SCEDs to refine the user interface prior to testing at the next SCED round.

In each SCED, a participant will be randomly assigned to one of 3 baseline conditions which vary in length.
Phase A1: (1) 1 week; (2) 2 weeks; (3) 3 weeks.
Phase B: Intervention with introduction of the user interface for 4 weeks.
Phase A2: follow up: 2 weeks.

Phase A1: baseline. Participants will be asked to wear the accelerometer only. During phase A1, participants will not have access to the user interface. All participants will commence phase A1 at the same time but will be randomised to the number of data collection points (includes 5, 7 or 9 data collection points) before commencing Phase B to account for internal threats to validity. Randomisation will be performed using an electronic allocation system that will be determined by non-study personnel through REDCap.

Phase B: introduction of the user interface and motivational interviewing (MI). The user interface will provide visual presentation of the child’s accelerometer data. The user interface will enable primary allied health practitioners to have the tools to support MI conversations for a client-centred problem-solving approach to reduce sedentary behaviours. During phase B, the primary allied health practitioner will provide weekly (either in person or through tele-health) 1 hour support, over 4 weeks to enable an individualised approach to supporting parents and carers with appropriate planning, scheduling and co-ordination whilst considering each child’s unique presentation and co-morbidities. Children and youth that can participate in MI can do so with the use of any communicative support that they may require. The primary allied health practitioner will also support children and their parents or carers to use the user dashboard throughout the week with aim for daily engagement for at least 5 minutes per day to review their daily activity. The user dashboard will be co-designed by consumers. As such, the exact format of the user interface is not concretely known as yet as the co-design process is still to occur. The interface could be an app on their own mobile device, a tablet, website or smart watch. Regardless of interface type, the information that will be displayed will have two main features:
1. Movements and postures that can be detected using the machine learning activity classification modes. Display of these movements and postures will enable children, parents and primary allied health practitioners to select the most appropriate and feasible options that could be used to reduce total sedentary time by 10 minutes a day.
2. Real time movement data collected from the child’s accelerometer.

The strategies that will be employed during the primary allied health care intervention may be employed through the user interface itself, in a typical therapy consultation, or both:
1. Goal setting
Collaboratively set goals for sedentary behaviour/physical activity. Goals focus on the behaviour itself, not outcomes of the behaviour.
2. Goal scoring
Review and score goals. In light of progress or achievement, collaboratively consider whether any changes to the goals or behaviour change strategies are needed. Provide feedback on how successful the child and family were at meeting their goals (i.e., the score).
3. Self-monitoring of behaviour
Promote the use of the interface for self-monitoring of behaviour and discuss it.
4. Problem solving using MI framework
Using a conversation guide, undertake problem-solving using an MI/solutions-focused framework that is autonomy-supportive. Prompt adults/caregivers to analyse factors influencing the behaviour/s and generate strategies to overcome barriers and/or increase facilitators. Include the child in this process at a level appropriate to their age and cognition.
Basic MI training will be provided to the allied health care professional who may use some strategies with adults/caregivers where appropriate to:
- Highlight the discrepancy between the child’s current behaviour and the goal
- Make a written agreement about when and how the behaviour will occur (e.g., that the adult will support child standing at music class once a week)
- Facilitate words of commitment to be said by the adult (e.g., “I will” statements)
- Provide emotional support
- Facilitate listing of advantages and disadvantages (e.g., about using or not using a standing frame)
- Facilitate imagining of likely or possible long-term outcomes of NOT changing the child’s behaviour, versus what could happen if it did
- Facilitate the adult identifying themselves as a physical activity role model
- Suggest the adoption of a new perspective, such as thinking of the tasks as swapping sedentary time for active time rather than simply reducing sedentary behaviour
- Draw attention to discrepancies between current behaviour and self-image, e.g., highlight that the teacher thinks of themselves as providing an inclusive environment, but that the child sitting while everyone else stands for art lessons may not be an inclusive practice when standing is possible
- Facilitate self-affirmations of personal strengths that align with the values of the intervention
5. Provide information about health, social and environmental consequences of sedentary behaviour and low physical activity in children with CP
Provide parents, caregivers, teachers, and relevant community members with specially designed information through the user interface that highlights the health, social and environmental consequences of sedentary behaviour and reduced physical activity participation in children with CP. The information uses graphics and words that are designed to emphasise the importance of the consequences, make them more memorable, and likely to stimulate action by the adult to help modify the child’s physical activity and sedentary behaviour levels.
6. Promote self-efficacy
Use verbal persuasion directed towards both the child and adults to promote their capability to change their behaviour/self-efficacy for physical activity and reduced sedentary behaviour, focus on the child’s past and current successes in changing their physical activity behaviours, and encourage (where relevant) positive self-talk by the child and adults “I can”.

Phase A2: follow-up. Over the course of two weeks, the accelerometer will remain on the child. However, the user interface and weekly primary allied health appointments will be withdrawn. Daily physical activity and sedentary behaviour will therefore still be measured over this time but there will be no weekly allied health visits or user interface feedback throughout the two week period.

Children will wear the accelerometer the whole duration of time through each of the phases.

Participants in the advisory council will meet two additional times (maximum of 2 hours long each) to consider feedback from SCED and make recommendations on changes to the user interface.
Intervention code [1] 324426 0
Rehabilitation
Intervention code [2] 324660 0
Treatment: Devices
Comparator / control treatment
Each individual will act as their own control i.e. the individual's performance in the baseline period will be compared to the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 332536 0
Physical activity
Participants will be asked to wear the watch-like device accelerometer daily. The raw data will then be analysed using our machine learning algorithms specific to children with cerebral palsy (CP) within a Gross Motor Function Classification System (GMFCS) levels IV and V to identify and quantify time spent in physical activity (i.e. not lying down or sitting).
Timepoint [1] 332536 0
Physical activity is a target behaviour that will be measured using accelerometry throughout the A (baseline) and B (intervention) phase of the trial and A2 (follow up). Characteristically in the SCED design, the target behaviour of total daily physical activity time will be measured at the 24 hour intervals throughout each of the phases.
Secondary outcome [1] 413845 0
Sleep Disturbance Scale
A screening questionnaire that has been used as a measure of children’s sleep (including domains of sleep onset, respiration, parasomnias such as restlessness and bruxism). It can be used to measure previous 4 weeks of children’s sleep, and has been used before and after sleep related interventions
Timepoint [1] 413845 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [2] 413846 0
Performance and satisfaction ratings on the Canadian Occupational Performance Measure (COPM)
The COPM is a widely used outcome measure for children with CP that identifies performance problems in a top down approach in both clinical practice and research. This measure is client/family centered and is therefore the most suitable measure for activity and participation in this population. The COPM is valid, reliable and responsive to changes following intervention from the patient/family’s perspective.
Timepoint [2] 413846 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [3] 413847 0
CPCHILD
The CPCHILD a valid and reliable proxy measure specifically developed for non-ambulant children with CP to determine changes in functional health status, health related quality of life and caregiver burden. The measure contains 36 items and 7 domains which include (1) personal care/activities of daily living, (2) positioning, transfers and mobility, (3) comfort (includes pain and discomfort) and emotions, (4) communication and social interaction, (5) health, (6) overall quality of life.
Timepoint [3] 413847 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [4] 414829 0
Implementation Effectiveness - Semi-structured interview with participating parents and primary allied health practitioners based on an interview guide to cover areas of implementation (acceptability, adoptability, appropriateness, feasibility, fidelity, implementation cost, penetration, sustainability)
Timepoint [4] 414829 0
Immediately post intervention (end of B phase).

Eligibility
Key inclusion criteria
Children with cerebral palsy, aged between 5 and 17 years classified within GMFCS levels IV and V.
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable hip dislocations, orthopaedic surgery (lower limb) in the past 6 months, uncontrolled seizures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation using a computer generated sequence will occur after the first assessment (pre-baseline). This randomisation will determine the length of A1 i..e., the time before the interface is introduced.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e., computerised sequence generation) will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
This is a single case experimental design featuring concurrent, randomised, replication multiple-baseline design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Means and standard deviations for interval data or medians and ranges for ordinal data will be calculated for each outcome measure for each participant. Comparisons between the A and B phases will be made. Individually using (a) visual analysis for changes in level, (b) the 2 standard deviation band method (2SD) for interval data or percentage of non overlapping data method for ordinal data) to assess change in level and (c) the C-statistic to assess change in slope/trend. Statistical significance will be reached in the 2SD band method if 2 consecutive data points lay outside the 2 SD band in the B phase. In the percentage of non overlapping data method, a median line will be drawn from the baseline data, and the strength of change will depend upon the percentage of points in the B phase that lay above or below this line. The C-statistic will assess trend and the A phase, and if no significant trend is found, the C-statistic will be computed for the combined A and B phases. If this result is significant, a treatment effect will be found. Autocorrelation will be calculated for each outcome measure to ensure that serial dependency does not influence our interpretation of the visual anlaysis and the 2SD band method (as autocorrelation can decrease the variability in the data and increase the likelihood of concluding incorrectly that a difference exists between the phases when using the visual analysis and 2SD band method. If autocorrelation is found, these methods will need to be applied with more caution.

Clinically meaningful change will be calculated for the Canadian Occupational Performance Measure where each individual participant will be assessed for meaningful change (score change of > 2). All data will be analysed using Stata 14.1 (StataCorp, College Station, TX). Qualitative data will be analysed using a method of trustworthiness

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
Date of last participant enrolment
Anticipated
7/07/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312231 0
Government body
Name [1] 312231 0
Department of Health and Aged Care (Medical Research Future Fund)
Country [1] 312231 0
Australia
Primary sponsor type
Government body
Name
Department of Health and Aged Care
Address
Department of Health and Aged Care
GPO Box 9848
Canberra ACT 2601
Australia
Country
Australia
Secondary sponsor category [1] 313766 0
None
Name [1] 313766 0
Nil
Address [1] 313766 0
Nil
Country [1] 313766 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311610 0
Curtin University
Ethics committee address [1] 311610 0
Ethics committee country [1] 311610 0
Australia
Date submitted for ethics approval [1] 311610 0
04/10/2022
Approval date [1] 311610 0
Ethics approval number [1] 311610 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121706 0
Dr Dayna Pool
Address 121706 0
The Healthy Strides Foundation
23/954 Albany Highway East Victoria Park WA 6101
Country 121706 0
Australia
Phone 121706 0
+61 0861092938
Fax 121706 0
Email 121706 0
[email protected]
Contact person for public queries
Name 121707 0
Dayna Pool
Address 121707 0
The Healthy Strides Foundation
23/954 Albany Highway East Victoria Park WA 6101
Country 121707 0
Australia
Phone 121707 0
+61 0861092938
Fax 121707 0
Email 121707 0
[email protected]
Contact person for scientific queries
Name 121708 0
Dayna Pool
Address 121708 0
The Healthy Strides Foundation
23/954 Albany Highway East Victoria Park WA 6101
Country 121708 0
Australia
Phone 121708 0
+61 0861092938
Fax 121708 0
Email 121708 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified individual participant data will not be available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.