Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000313336
Ethics application status
Approved
Date submitted
1/02/2017
Date registered
28/02/2017
Date last updated
23/08/2022
Date data sharing statement initially provided
8/01/2019
Date results provided
3/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
SPORTS STARS: How well does a sports focused physiotherapy group for children with Cerebral Palsy improve movement and sports participation.
Scientific title
SPORTS STARS: Efficacy of a group physiotherapy intervention to improve fundamental motor skills and sports participation in ambulant school-aged children with cerebral palsy: A randomised wait-list controlled trial.
Secondary ID [1] 290441 0
None
Universal Trial Number (UTN)
U1111-1189-3355
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy
 300796 0
Fundamental motor skills 300797 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300622 300622 0 0
Physiotherapy
Neurological 301838 301838 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sports Stars is a fundamental movement skills therapy using variable practice to prepare children with CP for participation in sports.

Therapists will be provided with an online package of intervention documents which detail the intervention. These will be accessed through CPL’s intranet. The session plans detail the intervention provided each week with 3 levels of difficulty. Equipment utilised in these groups included basic sporting equipment such as balls, bats and goals.

Sports Stars includes 8 x 1 hour weekly group sessions held after school. Each session includes 50 minutes of active participation in the group and 10 minutes for welcome/subjective review/discussion.

Therapy sessions: Each session included the following sections:
1. Warm up (5 minutes)
2. Activity- Locomotor Skills (15 minutes)
- Running
- Agility
- Coordination
3. Activity- Object Control Skills (15 minutes)
- Sending (kicking, batting, throwing, heading)
- Receiving (stopping, catching)
4. Participation- Modified Sports Game (10 minutes)
5. Cool Down (5 minutes)

Each activity includes 3 levels of difficulty that children can progress up when they are achieving the previous level as demonstrated within the group. Activities in Sports Stars should be challenging but achievable.

Sports Stars is a face to face group intervention held with 3-6 participants. The group runs for 8 weeks and includes variable practice of the above categories using four sports: Soccer, Netball, T-ball and Cricket. Two weeks are allocated to each sport to provide variation in activity whist still developing the same key movement skills described. Reminder calls will be made the day before the group and attendance will be monitored by the physiotherapist running the group with an attendance register to be completed each session.

Physiotherapists with at least one year’s experience working with children with Cerebral Palsy in a community setting will provide the Sports Stars intervention. Physiotherapists will undergo a training course on the Sports Stars program in addition to having access to video resources throughout the program.
Intervention code [1] 296286 0
Treatment: Other
Comparator / control treatment
A wait-list control will receive standard care throughout the intervention period. Following all assessment, participants in the waitlist group will then receive the Sports Stars intervention group. This will occur after all participants have completed the third assessment, 5 months after the commencement of the immediate intervention group.

Standard care describes the typical intervention that a 6-12 year old child with a diagnosis of Cerebral Palsy would receive. This may include neurodevelopmental therapy, context-focussed therapy, strength or fitness training or functional training etc. All intervention that the control group receives will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 300034 0
Canadian Occupational Performance Measure
Timepoint [1] 300034 0
Pre-intervention
Immediately post-intervention
3 months post intervention
Secondary outcome [1] 328868 0
10-meter shuttle run test
Timepoint [1] 328868 0
Pre-intervention
Immediately post-intervention
3 months post intervention
Secondary outcome [2] 328869 0
Functional strength field tests – Standing Broad Jump, Vertical Jump and Seated Throw
Timepoint [2] 328869 0
Pre-intervention
Immediately post-intervention
3 months post intervention
Secondary outcome [3] 328870 0
10x15m Sprint Test
Timepoint [3] 328870 0
Pre-intervention
Immediately post-intervention
3 months post intervention
Secondary outcome [4] 328871 0
Muscle Power Sprint Test
Timepoint [4] 328871 0
Pre-intervention
Immediately post-intervention
3 months post intervention
Secondary outcome [5] 328872 0
GMFM Challenge Module
Timepoint [5] 328872 0
Pre-intervention
Immediately post-intervention
3 months post intervention
Secondary outcome [6] 328873 0
Children’s Assessment of Participation and Enjoyment (CAPE) total and activity types:
Recreational, Physical activities, Social activities, Skill-based activities and Self-improvement activities
Timepoint [6] 328873 0
Pre-intervention
Immediately post-intervention
3 months post intervention
Secondary outcome [7] 328874 0
CP QOL-Child
Timepoint [7] 328874 0
Pre-intervention
Immediately post-intervention
3 months post intervention
Secondary outcome [8] 331193 0
TGMD-2 Test of Gross Motor Development Version 2
Timepoint [8] 331193 0
Pre-intervention
Immediately post-intervention
3 months post intervention
Secondary outcome [9] 331194 0
Timed up and go (TUG)
Timepoint [9] 331194 0
Pre-intervention
Immediately post-intervention
3 months post intervention
Secondary outcome [10] 332118 0
Preferences of Activities for Children (PAC)-total and activity types:
Recreational, Physical activities, Social activities, Skill-based activities and Self-improvement activities
Timepoint [10] 332118 0
Pre-intervention, Immediately post-intervention, 3 months post-intervention AND 2-4 years post-intervention.

Eligibility
Key inclusion criteria
Children aged 6-12 years:
* With a diagnosis of cerebral palsy.
* Who are ambulant without aids (GMFCS I-II).
* Who are able to commit to attending all assessments and all treatment sessions in the 8-week intervention.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:
* Any orthopaedic or neurological surgery during or 6 months prior to the immediate intervention period.
* Botulinum Toxin injections during or 3 months prior to the immediate intervention period.
* Behavioural or intellectual difficulties that would make it difficult to participate fully in assessments and/or group-based interventions.
* Medical comorbidities preventing safe physical activity.

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)
The outcome of the coin flip (Heads= 1= immediate intervention, 2= waitlist control) will be written on a piece of paper and concealed in an opaque envelope, securely stored offsite.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants in each geographical location will be randomly assigned to either the immediate intervention group or the waitlist control group with a 1:1 block allocation via coin flipping off site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculations are based on adequate power for comparison between effects of the Sports Stars program compared to standard care using the COPM immediately post intervention (T2). Data from a previous study investigating the effects of an exercise group aiming to improve physical activity, balance and strength in ambulant children (6-14 years) with CP showed a standard deviation of 1.87/2.88 (intervention/control) (Atasavun Uysal & Baltaci, 2016). This standard deviation and a mean change of 2 points for performance on the COPM (clinically meaningful difference) were used to calculate sample size. Based on significance (alpha) of 0.05 and 80% power, a minimum sample of 25 participants in each group (50 participants total) will be required. 60 participants (30 in each group) will be recruited to allow for 20% drop out.

Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the statistical analysis plan can be found, if not in the protocol.
Statistical analysis will be performed by the chief investigator using SPSS statistical software. Primary analysis will use the intention to treat principle, using the last observation recorded for participants who withdraw from the program. Baseline data will be reported using descriptive statistics for each variable (individual sports goals measured with COPM, GM capacity, aerobic fitness, anaerobic fitness and agility, functional LL & UL strength, participation and QOL) to establish any difference between randomised groups. If characteristics are not comparable at baseline, they will be modeled as covariates in subsequent analyses in order to adjust their possible confounding effects. Linear mixed models will be used to evaluate the effectiveness of the Sports Stars intervention compared to the waitlist control on the primary outcome (COPM). Linear mixed models take into account variation in individuals over time, are able to manage missing data without excluding participants for further analysis and examine changes in the outcomes over time as well as across the two groups. Significance will be set at p<0.05. Residuals of the fitted models will be examined to ensure that all required assumptions are met.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2017
Actual
6/03/2017
Date of last participant enrolment
Anticipated
30/07/2018
Actual
26/07/2018
Date of last data collection
Anticipated
31/12/2021
Actual
6/08/2021
Sample size
Target
60
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294846 0
Government body
Name [1] 294846 0
Gambling Community Benefit Fund
Country [1] 294846 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] 293685 0
Charities/Societies/Foundations
Name [1] 293685 0
The Cerebral Palsy League of Queensland
Address [1] 293685 0
340 Adelaide St, Brisbane City
Brisbane City QLD 4000
Country [1] 293685 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296231 0
The Cerebral Palsy League of Queensland
Ethics committee address [1] 296231 0
Ethics committee country [1] 296231 0
Australia
Date submitted for ethics approval [1] 296231 0
25/11/2016
Approval date [1] 296231 0
14/12/2016
Ethics approval number [1] 296231 0
CPL-2016-004
Ethics committee name [2] 296812 0
The Univeristy of Queensland
Ethics committee address [2] 296812 0
Ethics committee country [2] 296812 0
Australia
Date submitted for ethics approval [2] 296812 0
04/01/2017
Approval date [2] 296812 0
11/01/2017
Ethics approval number [2] 296812 0
2017000006

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

Contacts
Principal investigator
Name 70102 0
Dr Georgina Clutterbuck
Address 70102 0
School of Health Sciences
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 70102 0
Australia
Phone 70102 0
+61 418332325
Fax 70102 0
Email 70102 0
[email protected]
Contact person for public queries
Name 70103 0
Georgina Clutterbuck
Address 70103 0
School of Health Sciences
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 70103 0
Australia
Phone 70103 0
+61 418332325
Fax 70103 0
Email 70103 0
[email protected]
Contact person for scientific queries
Name 70104 0
Georgina Clutterbuck
Address 70104 0
School of Health Sciences
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 70104 0
Australia
Phone 70104 0
+61 418332325
Fax 70104 0
Email 70104 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7213Study protocol Clutterbuck G, Auld ML, Johnston LM. SPORTS STARS study protocol: a randomised, controlled trial of the effectiveness of a physiotherapist-led modified sport intervention for ambulant school-aged children with cerebral palsy.(Report). BMC pediatrics. 2018;18(1). doi: 10.1186/s12887-018-1190-z.  



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSPORTS STARS study protocol: A randomised, controlled trial of the effectiveness of a physiotherapist-led modified sport intervention for ambulant school-aged children with cerebral palsy.2018https://dx.doi.org/10.1186/s12887-018-1190-z
EmbaseSPORTS STARS: a practitioner-led, peer-group sports intervention for ambulant children with cerebral palsy. Activity and participation outcomes of a randomised controlled trial.2022https://dx.doi.org/10.1080/09638288.2020.1783376
N.B. These documents automatically identified may not have been verified by the study sponsor.