Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001064594
Ethics application status
Approved
Date submitted
23/09/2015
Date registered
13/10/2015
Date last updated
12/02/2020
Date data sharing statement initially provided
12/02/2020
Date results provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, wait-list controlled trial of a physiotherapy and behaviour change intervention to increase physical activity through meaningful participation for children with cerebral palsy and their caregiver
Scientific title
In children with cerebral palsy aged 8-12 years, what is the effect of an 8-week physiotherapy and motivational interviewing intervention delivered to the child and their primary caregiver, as compared to a wait-list control receiving usual care, on child participation in active leisure and sports, and habitual physical activity levels?
Secondary ID [1] 287473 0
Nil Known
Universal Trial Number (UTN)
U1111-1174-5013
Trial acronym
ParticiPAte CP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 296207 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296488 296488 0 0
Physiotherapy
Neurological 296489 296489 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dosage and Location:
Participating child-parent dyads allocated to the intervention group will be present for a 1-hour intervention session with a physiotherapist once weekly over an 8-week intervention period. The majority of intervention sessions will take place in the participant's home environment with the physiotherapist travelling to the participant. There is an 8-week follow-up period where no treatment will be provided at the conclusion of the intervention period.
Intervention:
The intervention is a novel integration of goal-directed, family-centred physiotherapy with a behaviour change counselling technique called motivational interviewing. The intervention is individualised to each child-parent dyad based on their reported barriers and facilitators to participation, and therefore not every possible intervention element will apply to all dyads. The common elements are: collaborative goal-setting, motivational interviewing, action-planning, and provision of information and advice. Other elements likely to be delivered include: motor-learning approach physiotherapy, home exercise programs, equipment suggestion, problem-solving, and communication with stakeholders.
Adherence:
Participants will be sent text message reminders about their scheduled appointments. Parents will be directed to individually relevant internet and media resources to view in their own time. Child-parent dyads must participate in the development of a maintenance plan, which outlines how progress in physical activity participation will be continued or maintained, at the end of the 8-week period.
Other:
Participants may continue their usual care therapies (physiotherapy, occupational therapy, speech-language therapy, psychology etc.) during the intervention and follow-up period, although episodes of care must be recorded in a usual care diary.
Intervention code [1] 292855 0
Rehabilitation
Intervention code [2] 292856 0
Behaviour
Intervention code [3] 293004 0
Treatment: Other
Comparator / control treatment
Dosage and Location:
Participating child-parent dyads allocated to the waitlist control group will be present for 3 1-hour sessions in total - at the first and last weeks of the 8-week intervention period and at the conclusion of the 8-week follow-up period.
Control condition:
Child-parent dyads will participate in goal setting and goal performance evaluation during the sessions one-one individual sessions with the physiotherapist. No other treatment will be provided for the 8-week intervention and 8-week follow-up periods. The participants will receive the study physiotherapy and motivational interviewing intervention at the conclusion of the entire waitlist period (intervention and follow-up periods, approximately 16 weeks).
Other:
Participants may continue their usual care therapies (physiotherapy, occupational therapy, speech-language therapy, psychology etc.) during the waitlist period, although episodes of care must be recorded in a usual care diary.
Control group
Active

Outcomes
Primary outcome [1] 296113 0
Physical activity participation goal performance and satisfaction: Canadian Occupational Performance Measure (COPM)
Timepoint [1] 296113 0
Measured at baseline, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention.
Primary outcome [2] 296114 0
Habitual Physical Activity Level: Minutes of Moderate to Vigorous Physical Activity per day, over 7 days (ActiGraph GT3x)
Timepoint [2] 296114 0
Measured at baseline, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention.
Primary outcome [3] 296115 0
Physical activity participation incremental goal attainment: Goal Attainment Scaling (GAS)
Timepoint [3] 296115 0
Measured mid-intervention, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention. GAS is subject to within group analyses only (will not be scored for the waitlist control group during the waitlist period).
Secondary outcome [1] 317542 0
Participation in Home, School and Community and Environmental Supports/Barriers: Participation and Environment Measure - Children and Youth (PEM-CY)
Timepoint [1] 317542 0
Measured at baseline, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention.
Secondary outcome [2] 317543 0
Barriers and Facilitators to Participation in Physical Activities, based on Theories of Behaviour Change: TDF Questionnaire
Timepoint [2] 317543 0
Measured at baseline, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention.
Secondary outcome [3] 317548 0
Condition-specific Quality of Life: CP-QOL Child
Timepoint [3] 317548 0
Measured at baseline, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention.
Secondary outcome [4] 317549 0
Type and Extent of Motivation for Physical Activities: Motives for Physical Activities Measure (MPAM-R)
Timepoint [4] 317549 0
Measured at baseline, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention.
Secondary outcome [5] 317550 0
Extent of Autonomy Supportive or Controlling Parenting Style: Problems in Schools Questionnaire (PISQ)
Timepoint [5] 317550 0
Measured at baseline, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention.
Secondary outcome [6] 317551 0
Perceived Parental Autonomy-supportiveness for Physical Activities: Perceived Autonomy Support Climate Questionnaire (PASCQ)
Timepoint [6] 317551 0
Measured at baseline, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention.

Eligibility
Key inclusion criteria
Participants are children with a diagnosis of Cerebral Palsy (GMFCS I-III, confirmed by the Child’s Paediatrician, Rehabilitation Physician, or Neurologist), aged between 8 and 12 years inclusive. The primary residence of the child during the study period is within 200kms of South Brisbane, Queensland.

Each included child’s primary caregiver (one person who has a long-term parenting role including a biological parent, step parent, adoptive parent or foster parent AND has at least 30% of caregiving responsibilities) is also a participant.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children are excluded if they:
(1) Have limited ability to communicate insight into a preferred future (needs, wants and desires) in spoken English AND/OR through an interpreter or augmentative and alternative communication (i.e. Communication Function Classification System levels IV-V and/or children with moderate to severe intellectual disability)
(2) Have uncontrolled epilepsy (as this may impact on safety to engage in certain physical activities)
(3) Have a severe visual impairment or blindness (defined as 6/60 vision or lower, when appropriately corrected, in the better eye, or in the written opinion of an ophthalmologist the cortical visual impairment, visual field loss and/or other deficits result in a combined approximate acuity of 6/60 or lower)
(4) Have severe asthma exacerbated by exercise that is not controlled with medications under an asthma management plan
(5) Have orthopaedic and/or neurological surgery 6 months prior to and/or planned during the entire study period including follow-up assessments. Intramuscular botulinum toxin (BoNT-A) injections in the lower limbs and some minor surgeries may not automatically exclude entry

Caregivers are excluded if they:
(1) Have a diagnosed moderate to severe intellectual disability or significant communication impairment

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)
Allocation will be concealed by sealed, numbered, opaque envelopes opened by a person who is not associated with the research study. Participants will not be informed of their allocation until allocation is complete and irrevocable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using computerised sequence generation. Stratification factors are sex (Male, Female), and Gross Motor Function Classification System (I-II, III).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
The COPM and GAS goal outcomes are administered by the treating therapist as part of the intervention, and therefore they cannot be blinded. However, an independent person will also rate the goal outcomes attained and the ratings will be compared.

Participants are allocated to an intervention group or a wait-list group. The wait-list cohort receives the study treatment when the matched intervention cohort has finished their treatment and follow-up periods. There is no comparator or follow-up outcomes for the wait-list cohort during their treatment (pre-post outcomes only).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome of the intervention will be assessed using generalised estimating equations for longitudinal analysis to evaluate differences in continuous data at post-intervention and 8-week follow-up assessments, on an intention-to-treat basis. This method takes into account the repeated measures on each participant and the potential for missing data. For the COPM performance score, the co-variables will be time (3 level – 0, 8, and 16 weeks) and group (immediate treatment and wait-list), with a group*time interaction (which will test for the differences between groups at different time points). Further analyses using t-tests will compare outcomes between groups at the primary (8 week) and retention (16 weeks) endpoints for the secondary outcome measures. The GAS goal attainment scores will be analysed on a within-groups basis with Wilcoxon Signed Rank Tests for the whole cohort at end-intervention (GAS scores will not be normally distributed). Statistical significance will be set at p<0.05 with adjustments for multiple comparisons where relevant. Validity of results will be checked using baseline and general descriptive information available for all eligible families. This includes comparing key characteristics of families who completed the study with those who enrolled in the study but did not complete, and those who did not enrol using the best available information from current population-based statistics.

The sample size calculation is based on adequate power for comparison between ParticiPAte CP and usual care on COPM goal performance at the primary endpoint (T1, 8 weeks, immediately post intervention). A change score difference of 2 points on the COPM-performance subscale would be clinically meaningful. A previous pilot study utilising the COPM as an outcome measure for activity and participation goal attainment in six children and youth with physical disabilities yielded standard deviations between 1.4 and 1.7 for COPM-performance. Based on a conservative estimate using a mean change of two points (STATA 13.1, power 0.8, two-tailed, p<0.05), we require 22 parent-child dyads (11 per group). Allowing for 20% drop out and missing data on actigraphy, a total of 36 parent-child dyads (18 per group) will be recruited.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/10/2015
Actual
28/12/2015
Date of last participant enrolment
Anticipated
29/05/2017
Actual
3/04/2017
Date of last data collection
Anticipated
18/08/2017
Actual
5/09/2017
Sample size
Target
36
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 7877 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 15824 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 292051 0
University
Name [1] 292051 0
QCPRRC Central Funds, The University of Queensland
Country [1] 292051 0
Australia
Funding source category [2] 293616 0
Charities/Societies/Foundations
Name [2] 293616 0
Cerebral Palsy Alliance Research Foundation Grant
Country [2] 293616 0
Australia
Primary sponsor type
Individual
Name
Sarah Reedman
Address
Queensland Cerebral Palsy and Rehabilitation Research Centre
The University of Queensland, School of Medicine
Level 6, Centre for Children's Health Research
62 Graham Street
SOUTH BRISBANE, QLD 4101
Country
Australia
Secondary sponsor category [1] 290724 0
University
Name [1] 290724 0
The University of Queensland, School of Medicine
Address [1] 290724 0
Mayne Medical School
288 Herston Road
HERSTON, QLD 4006
Country [1] 290724 0
Australia
Other collaborator category [1] 279536 0
University
Name [1] 279536 0
Curtin University
Address [1] 279536 0
GPO Box U1987, Perth
Western Australia, 6845
Country [1] 279536 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293536 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 293536 0
Ethics committee country [1] 293536 0
Australia
Date submitted for ethics approval [1] 293536 0
24/08/2015
Approval date [1] 293536 0
06/10/2015
Ethics approval number [1] 293536 0
HREC/15/QRCH/162
Ethics committee name [2] 293537 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 293537 0
Ethics committee country [2] 293537 0
Australia
Date submitted for ethics approval [2] 293537 0
08/10/2015
Approval date [2] 293537 0
13/10/2015
Ethics approval number [2] 293537 0
2015001609

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

Contacts
Principal investigator
Name 60342 0
Ms Sarah Reedman
Address 60342 0
Queensland Cerebral Palsy and Rehabilitation Research Centre,
The University of Queensland School of Medicine,
Level 6, Centre for Children's Health Research
62 Graham Street
SOUTH BRISBANE, QLD 4101
Country 60342 0
Australia
Phone 60342 0
+61 07 3069 7336
Fax 60342 0
Email 60342 0
[email protected]
Contact person for public queries
Name 60343 0
Leanne Sakzewski
Address 60343 0
Queensland Cerebral Palsy and Rehabilitation Research Centre,
The University of Queensland School of Medicine,
Level 6, Centre for Children's Health Research
62 Graham Street
SOUTH BRISBANE, QLD 4101
Country 60343 0
Australia
Phone 60343 0
+61 07 3069 7345
Fax 60343 0
Email 60343 0
[email protected]
Contact person for scientific queries
Name 60344 0
Sarah Reedman
Address 60344 0
Queensland Cerebral Palsy and Rehabilitation Research Centre,
The University of Queensland School of Medicine,
Level 6, Centre for Children's Health Research
62 Graham Street
SOUTH BRISBANE, QLD 4101
Country 60344 0
Australia
Phone 60344 0
+61 07 3069 7336
Fax 60344 0
Email 60344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseParticiPAte CP: A protocol of a randomised waitlist controlled trial of a motivational and behaviour change therapy intervention to increase physical activity through meaningful participation in children with cerebral palsy.2017https://dx.doi.org/10.1136/bmjopen-2017-015918
EmbaseParticipation predictors for leisure-time physical activity intervention in children with cerebral palsy.2021https://dx.doi.org/10.1111/dmcn.14796
N.B. These documents automatically identified may not have been verified by the study sponsor.