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Trial registered on ANZCTR


Registration number
ACTRN12614000467639
Ethics application status
Approved
Date submitted
22/04/2014
Date registered
5/05/2014
Date last updated
2/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A running training and lifestyle programme for children with cerebral palsy
Scientific title
Evaluation of a goal directed running training and lifestyle programme on changes to activity levels in children with cerebral palsy.
Secondary ID [1] 284471 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
activity levels of children with cerebral palsy 291707 0
running ability of children with cerebral palsy 291708 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292085 292085 0 0
Physiotherapy
Neurological 292147 292147 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Training Programme
The training programme includes a functional and skill based running training programme based on that developed by Gavin Williams for adults with ABI (G. P. Williams & Morris, 2009) plus an addition of a lifestyle intervention aspect that includes education and counselling the participant, and school and parent.

The running training programme will be performed in two ‘hub’ sites within the Perth metropolitan area, one south of the river and one north of the river. The training programme consists of a three month training programme of high-level mobility activities conducted twice weekly for an hour at each session. The programme developed by Williams is based on achieving the biomechanical requirements for running and emphasises strength and the control of speed and movement (G. P. Williams & Morris, 2009). It includes strengthening exercises, pre-running and running drills and agility exercises. The programme is supplemented with a gym or home exercise programme. The programme utilises no specialised aids or equipment so that it can be replicated and transferred to a home or gym setting. Participants will have an individually tailored programme that they complete in a group setting. This programme will be supplemented with a gym or home exercises programme 2–3 days/week with participants expected to train a minimum of 4 days/week. Adherence to the programme will be monitored through the weekly attendance sheets where participants will be asked to also record their additional completed training at home. The therapists who supervise the running training groups will determine the supplementary programme. Specialised training for six physiotherapists who will run and supervise the programme will occur.

The lifestyle aspect will focus on strategies to enable the child or young person to adopt an active lifestyle within the family and school context. This aspect will include motivational interviewing, goal setting strategies with family and school and strategies to practice/continue with the mobility related training in the daily situation. The lifestyle aspect of the intervention is administered as fortnightly 1 hour group sessions over the 12 weeks with both the parent and participant invited to attend.

Intervention code [1] 289229 0
Rehabilitation
Intervention code [2] 289230 0
Lifestyle
Comparator / control treatment
The control group will continue with their usual standard therapy provided by their community therapists. For this age group (9-18 years) this usually involves a consultative model of care whereby the therapists provides information about appropriate activities that the individual should engage in. contact is limited by resources to approximately 3-5 sessions per 3 months.
Control group
Active

Outcomes
Primary outcome [1] 291957 0
Changes in daily activity level will be assessed using an ActiGraph wGT3X-BT wireless activity monitor (ActiGraph, Florida USA), in conjunction with the ActiLife software platform. The ActiGraph has been chosen as it has previously been used in clinical outcome assessment and research at Princess Margaret Hospital and at Curtin University of technology and has good validity and reliability (John & Freedson, 2012). The ActiGraph wGT3X-BT can provides 24 hour physical activity and sleep/wake measurements including raw acceleration, energy expenditure, MET rates, steps taken, physical activity intensity, heart rate, subject position, total sleep time, sleep efficiency, and ambient light levels.

Participants will be asked to wear the ActiGraph accelerometer during most waking hours for 3 consecutive days. Accelerometers will be initialized before data collection and will be set to begin collecting data at 7:00 AM on the day after they are distributed to participants. The accelerometer will be worn on the right hip of the participant attached by a belt. They will be asked to wear the ActiGraph at all times except at night while sleeping and while bathing or swimming. Data will be collected and stored in 30-second intervals.
Timepoint [1] 291957 0
Baseline, and at 3 months and 6 months post intervention
Primary outcome [2] 291959 0
Changes in participation will be assessed using the Children’s Assessment of Participation and Enjoyment(CAPE) questionnaire (King et al., 2004) and The Participation and Environment Measure for Children and Youth (PEM-CY) (Coster et al., 2012).
Timepoint [2] 291959 0
Baseline, and at 3 months and 6 months post intervention
Primary outcome [3] 291960 0
3D motion analysis of running performance using an 18 camera motion analysis system (VICON, OXFORD UK)(250Hz) combined with 2 force plates (AMTI, Watertown, MA) (1000Hz). Validity and reliability of this data capture system has been determined. Gait analysis will give information about joint angles, joint accelerations, ground reaction forces and joint moments during running.
Timepoint [3] 291960 0
Baseline, and at 3 months and 6 month post intervention
Secondary outcome [1] 307926 0
Aerobic fitness will be evaluated using the 10-metre shuttle run test that has been validated in children with cerebral palsy (Verschuren, Takken, Verschuren, & Takken, 2006). This is an adapted version of the 20-metre shuttle run test to accommodate children with CP classified at Level I or Level II on the Gross Motor Function Classification System (GMFCS) (Verschuren et al., 2006). Separate protocols exist for each level (SRT-1 and SRT-2).
Timepoint [1] 307926 0
Baseline, and at 3 months and 6 month post intervention
Secondary outcome [2] 307927 0
Functional muscle strength will be measured with three functional exercises in which the large muscle groups that are important in daily activity: the 30-second Lateral Step-Up Test(Verschuren, Ketelaar, Takken, van Brussel, et al., 2008), the 30-second Sit-to-stand Test(Verschuren, Ketelaar, Takken, van Brussel, et al., 2008) and the 30-second 1/2 kneel to stand test (Verschuren, Ketelaar, Takken, van Brussel, et al., 2008). The 30-second Lateral Step-Up Test assesses the number of step ups that the child can perform in 30 seconds. The test is performed on a 21 cm (GMFCS I and II) or an 11 cm (GMFCS III) step. The 30-second Sit-to-Stand Test assesses the number of sit-to-stands that the child can perform in 30 seconds. The test is performed on a child-sized chair with a height-adaptable seat (no backrest, no armrest).The 30-second 1/2 Kneel to Stand test assesses the number of times the child can attain stand through half kneel, without using arms, in 30 seconds. For the 30-second Lateral Step-Up Test and the 30-second 1/2 Kneel to Stand Test are assessed bilaterally. During the Sit to Stand Test both extremities are used to perform the task. Total scores for the left and right side are calculated from the repetition maximums for each side, so in total 5 scores will be calculated. There is acceptable reliability (ICC=0.91; Coefficient of Variation 10.9 – 39.9%) for all three functional strength measures (Verschuren, Ketelaar, Takken, van Brussel, et al., 2008).
Timepoint [2] 307927 0
Baseline, and at 3 months and 6 month post intervention
Secondary outcome [3] 307928 0
Walking capacity will be assessed using the 6 minute walk test. The 6 minute walk test (6MWT) is a submaximal, clinical exercise test, in which the distance walked under controlled conditions in 6 min is measured. This test was originally developed for use with people with chronic obstructive pulmonary disease but has been used validly and reliably in children with CP (Maher, Williams, & Olds, 2008; Maltais, Robitaille, Dumas, Boucher, & Richards, 2012; Slaman et al., 2010; Thompson et al., 2008). In CP, the 6MWT is considered a measure of overall functional capacity, as performance of the 6MWT involves the integrated response of multiple body systems (respiratory, cardiovascular, and skeletal, nervous and muscular systems) (Maher et al., 2008; Verschuren, Maltais, & Takken, 2011).

Timepoint [3] 307928 0
Baseline, and at 3 months and 6 month post intervention
Secondary outcome [4] 307929 0
The 10MWT measures the time (in seconds) and number of footsteps needed to walk 10 meters. The 10 MWT test is performed on a 14 meter straight, flat, smooth, non-slippery walking surface. The child is instructed to walk at a self-selected comfortable speed. The time and number of footsteps for walking the intermediate 10 meters is measured and from this, cadence, step-length and comfortable walking velocity will be calculated.
Timepoint [4] 307929 0
Baseline, and at 3 months and 6 month post intervention
Secondary outcome [5] 312787 0
Achievement of running, improvements in activity and participation will all be evaluated using goal attainment scaling (GAS) (Kiresuk, Smith, & Cardillo, 1994). Considerable attention will be given to identifying and evaluating individual running goals for each child. Goals will be set in close collaboration with the child, the child’s parents and community physiotherapist. Three specific goals will be set for each child.
Timepoint [5] 312787 0
Baseline, and at 3 months and 6 month post intervention

Eligibility
Key inclusion criteria
Cerebral palsy or like conditions (neuromotor dysfunction e.g. Acquired Brain Injury)
Aged between 9 and 18 years
Gross Motor Function Classification (GMFCS) Level I-III. If Level III, the child must be able to walk 10 metres unassisted
Willingness of child and family to attend at least two after-school sessions per week for the duration of one school term and to participate in two other exercise sessions (at home or in a gym) per week.
Minimum age
9 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who have concomitant medical conditions that preclude participation in a vigorous exercise programme (e.g. unstable seizures, cardiac arrhythmia, mitochondrial defects, or significant hip dysplasia).
Children who have had surgery in the last 6 months.
Children who are unable to complete the pre intervention assessments.
Children with behavioural problems that may interfere with participation in a group.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
WA

Funding & Sponsors
Funding source category [1] 289120 0
Government body
Name [1] 289120 0
Non-Government Centre Support administered by Department of EducationWA, School of Special Educational Needs: Disability (SEND)
Address [1] 289120 0
Mr John Brigg
Principal
School of Special Educational Needs: Disability (SEND)
18 Blackboy Way
Beechboro WA 6063
Country [1] 289120 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
GPO BOX D184
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 287782 0
Charities/Societies/Foundations
Name [1] 287782 0
The Centre for Cerebral Palsy
Address [1] 287782 0
PO Box 61
Mount Lawley WA 6929
Country [1] 287782 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290900 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 290900 0
GPO Box D184
Perth WA 6000
Ethics committee country [1] 290900 0
Australia
Date submitted for ethics approval [1] 290900 0
05/05/2014
Approval date [1] 290900 0
25/11/2014
Ethics approval number [1] 290900 0
Ethics committee name [2] 292316 0
Curtin University
Ethics committee address [2] 292316 0
GPO Box U1987
Bentley WA 6845
Ethics committee country [2] 292316 0
Australia
Date submitted for ethics approval [2] 292316 0
04/12/2014
Approval date [2] 292316 0
18/12/2014
Ethics approval number [2] 292316 0
HR 219/2014

Summary
Brief summary
Even the most functional children with cerebral palsy (CP) who walk unassisted show limitations of high level mobility relative to their peers. Our clinical experience has been that these children articulate self identified goals around aspects of improving their high level mobility in particular running. In clinical reality these more functional children receive fewer services as they are perceived to be able to participate in aspects of recreation and activity that require higher levels of gross motor function. In daily reality, activity and participation restriction in children with CP who are ambulant exists.

There are a number of barriers that may contribute to restricted participation including poor physical capacity to undertake high level mobility tasks proficiently, in particular running. Running is the cornerstone for many individual and team sports and recreational activities, and has been reported to be a significant challenge for individuals with neuromotor dysfunction. There is evidence to suggest that children with CP have lower muscle mass, decreased muscle strength and poorer fitness. Two additional factors worth exploring is whether children have learned the motor components of running and whether they have adapted to a non active lifestyle. It may be that individuals with CP avoid or discontinue membership in sports and recreational activities that require speed and agility due to deficits in running ability.

Training programs that focus on teaching the components of running skill in children with CP appear to be unreported. Training the components and skill of running in CP is important for a number of reasons. Firstly, like many determinants of motor change and acquisition of skill in CP, therapy and training to achieve the skill is required. Unlike many therapeutic interventions that address the ability to walk, therapists working with CP rarely address the components in running to the same level. Secondly, running is often identified as a goal of intervention for school aged children, particularly as many school activities are focused around running such as school fun runs, lap-a-thons, daily fitness, general sport. Thirdly, although many interventions have been shown to improve muscle strength, anaerobic and aerobic capacity and even walking capacity in CP, few have demonstrated a translation of these gains into higher level mobility and increases in community participation.

We propose to run a three month running skill acquisition and training programme to determine its effect on running skill acquisition, improvement in higher level skill improvements in walking and running capacity and engagement into community programmes and participation. This is important because evidence suggests that physically inactive children are more likely to become physically inactive adults and that encouraging positive physical activity habits in children helps establish patterns that continue into adulthood.

The running programme will be run through The Centre for Cerebral Palsy (TCCP) at two of their metropolitan sites. In addition to the running training, a lifestyle aspect will be incorporated into the programme. The lifestyle component will focus on strategies to enable the child or young person to adopt an active lifestyle within their family and school context. This component will include cognitive based coaching and motivational interviewing to coach strategies to practice/continue with the activity related training in the daily situation.

The programme will be carried out collaboratively by therapists from TCCP and PMH. The Research Coordinator Physiotherapist from PMH was instrumental in initiating the idea of developing a running skills program, researching the ABI running program model and developing the proposal about how it may be best modified to suit children with CP. In addition PMH has physiotherapists involved in exercise lifestyle models in the obesity related programmes and the eating disorders programs. These PMH therapists have the specialised skills to guide the lifestyle intervention aspect of the proposed running model. This aspect of the intervention differs to that run by Williams and other adult facilities and is grounded in the family context of working with children and young people.

It was recognized the programme is best implemented in a community based setting by community providers. Physiotherapists at TCCP have extensive experience and knowledge in community based intervention programmes and working with families in the community. The collaboration of PMH with TCCP will bring together the specialist skills of each of these service providers to benefit the formulation and application of programme.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47882 0
Dr Noula Gibson
Address 47882 0
Princess Margaret Hospital
Department of Physiotherapy
GPO Box D184
Perth WA 6840
Australia
Country 47882 0
Australia
Phone 47882 0
+61 8 93408503
Fax 47882 0
Email 47882 0
noula.gibson@health.wa.gov.au
Contact person for public queries
Name 47883 0
Dr Noula Gibson
Address 47883 0
Princess Margaret Hospital
Department of Physiotherapy
GPO Box D184
Perth WA 6840
Country 47883 0
Australia
Phone 47883 0
+61 8 93408503
Fax 47883 0
Email 47883 0
noula.gibson@health.wa.gov.au
Contact person for scientific queries
Name 47884 0
Dr Noula Gibson
Address 47884 0
Princess Margaret Hospital
Department of Physiotherapy
GPO Box D184
Perth WA 6840
Country 47884 0
Australia
Phone 47884 0
+61 8 93408503
Fax 47884 0
Email 47884 0
noula.gibson@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary