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Trial registered on ANZCTR


Registration number
ACTRN12611000454976
Ethics application status
Approved
Date submitted
18/04/2011
Date registered
3/05/2011
Date last updated
13/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
GR IN: Evaluation of Group versus Individual Models of Physiotherapy for Children and Adolescents with Cerebral Palsy following Lower Limb Botulinum Toxin A injections.
Scientific title
A Single Blind Randomised Controlled Trial Comparing Group Versus Individual Models of Physiotherapy on Functional Mobility for Children and Adolescents with Cerebral Palsy following Lower Limb Botulinum Toxin A injections.
Secondary ID [1] 259877 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
GR IN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 265468 0
Condition category
Condition code
Neurological 265622 265622 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For a given recruitment period, eligible subjects will be assessed at baseline 0-2 weeks prior to receiving lower limb Botulinum Toxin A (BoNTA) injections. All subjects will then receive lower limb BoNTA as per present QCPHS protocol. Muscles to be injected will be selected by the Clinic Rehabilitation Consultant and physiotherapist according to assessment findings and clinical indications. Muscles selected will accordingly vary between subjects but must be in the lower limb as stated in the inclusion criteria. In the ambulant population, common muscles injected include medial hamstrings, gastrocnemius, soleus and tibialis posterior.

Dose is different for all children but is according to recommendations based on the consensus opinion of the 'We Move' Spasticity Study Group (2002). This is worked out on a dose/kilo/muscle ratio which calculates a total dose/kilo. The maximum dose allowed is 16 units/kilo or to a total adult dose of 400 units.

2-3 weeks post BoNTA injections, all subjects will commence their rehabilitation. Subjects will not be re-injected with BoNTA until completion of the rehabilitation and 6 month post BoNTA assessments (final assessment point and exit from study).

The Children allocated to the group-based intervention will receive physiotherapy together in a small group (3 or more children) with a physiotherapist and assistant. The format will consist of: 5 minutes warm up (group activity); 10 minutes of lower limb stretching (as a group); 4x5 minute circuit stations (group, paired or individual) addressing 1. Functional Strengthening 2. Balance 3. Targeted Motor Control 4. Fitness/Agility; 5 minutes warm down (group activity). Dose will consist of 6 sessions of physiotherapy provided in 1 hour sessions over 6 weeks. A standardised, individualised (3 activities related to individual goals to be completed 3 times a week) Home Exercise Programme will also be given to each participant and progressed each week as appropriate.
Intervention code [1] 264300 0
Rehabilitation
Comparator / control treatment
Children allocated to receive individual-based physiotherapy will receive it in a one-to-one format with a physiotherapist. The dose and content will be the same as the group intervention, the only difference being the format. Those allocated to the individual control treatment will also recieve the Home Exercise Programme as per the group intervention.
Control group
Active

Outcomes
Primary outcome [1] 262409 0
Quality of Gait will be compared to normal values using the Edinburgh Visual Gait Score for Cerebral Palsy (EVGS)
Timepoint [1] 262409 0
at baseline, 10 weeks post BoNTA (at completion of rehabilitation) and 6 months post BoNTA.
Primary outcome [2] 262410 0
Attainment of individual goals as measured by the Canadian Occupational Performance Measure (COPM, adapted for children).
Timepoint [2] 262410 0
at baseline, 10 weeks post BoNTA (at completion of rehabilitation) and 6 months post BoNTA.
Secondary outcome [1] 273722 0
Efficiency of Gait measured by the One Minute Walk Test (1MWT)
Timepoint [1] 273722 0
at baseline, 10 weeks post BoNTA (at completion of rehabilitation) and 6 months post BoNTA.
Secondary outcome [2] 273723 0
Functional Mobility measured by Sections D & E of the Gross Motor Function Measure (GMFM)
Timepoint [2] 273723 0
at baseline, 10 weeks post BoNTA (at completion of rehabilitation) and 6 months post BoNTA.
Secondary outcome [3] 273724 0
Functional Balance using the Functional (forward) and Lateral (side) components of the Paediatric Reach Test for children (PRT).
Timepoint [3] 273724 0
at baseline, 10 weeks post BoNTA (at completion of rehabilitation) and 6 months post BoNTA.
Secondary outcome [4] 273725 0
Physical Activity levels as measured by actigraph data
Timepoint [4] 273725 0
at baseline, 10 weeks post BoNTA (at completion of rehabilitation) and 6 months post BoNTA.
Secondary outcome [5] 273726 0
Health Related Quality Of Life will be measured using the specifically designed CP QOL-child
Timepoint [5] 273726 0
at baseline, 10 weeks post BoNTA (at completion of rehabilitation) and 6 months post BoNTA.
Secondary outcome [6] 273727 0
Participation as measured by 10 selected domains of The Assessment of Life Habits (LIFE-H) for children
Timepoint [6] 273727 0
at baseline, 10 weeks post BoNTA (at completion of rehabilitation) and 6 months post BoNTA.
Secondary outcome [7] 273728 0
Parent/Carer and Child Satisfaction with intervention formats as measured by specifically-designed questionnaires.
Timepoint [7] 273728 0
10 weeks post BoNTA (on completion of rehabilitation)
Secondary outcome [8] 273729 0
Participant's Motivation and Compliance with the physiotherapy intervention as measured by a specifically-designed Likert Scale
Timepoint [8] 273729 0
After each of the 6 physiotherapy sessions

Eligibility
Key inclusion criteria
The study will include children/adolescents aged 4-14 years with a diagnosis of spastic cerebral palsy who:
- are clients of the Queensland Cerebral Palsy Health Service
- require lower limb BoNTA to improve gait or mobility
- have a Gross Motor Function Classification System level I-III (Palisano, Rosenbaum et al. 1997)
- can commit to an intensive block of post BoNTA physiotherapy rehabilitation. This consists of 60 minutes, 1x a week for a total period of 6 weeks. Content of each 60 minute rehabilitation session will include: 5 minutes warm up activity; 10 minutes of lower limb stretching; 4x5 minute circuit stations with 1 minute inbetween each station to allow for rest/set up/drink. Stations to address: 1. functional strengthening 2. balance 3. targeted motor control 4. fitness/agility; 5 minutes warm down activity; 10 minutes review of home programme
Minimum age
4 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
- Unable to complete baseline assessments or their families are unable to commit to rehabilitation
- Have had orthopaedic or neurological surgery and/or other new spasticity management (eg Baclofen) in the previous 6 months to commencing the study
- Are unable to follow basic commands
- Have co-morbidities which prevent them from exercising safely (eg cardiac, respiratory)

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 randomisation process will involve allocating "group" or "individual" to numbers "1" or "2" via coin flipping by non-study personnel. Prior to commencement of recruitment, this process will be carried out 10 times (to allow for enough cohorts to recruit sufficient numbers to meet power calculations). Each allocation will be recorded on a piece of paper, folded and placed inside an envelope in a random order. For a given recruitment period, eligible subjects will be clustered equally into 2 'groups' "1" or "2" according to geographical location. This will address the need for logistical geographical planning of rehabilitation. The subjects will be allocated to the next consecutive envelope, which will be opened by the non-study personnel. They will read and record the treatment allocation from the paper inside (ie: 1= group, 2 = individual) and the study coordinator will be informed of the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple block randomisation will occur so that for a given recruitment period subjects will be grouped equally into "1" or "2' according to geographical location of residence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
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)

Funding & Sponsors
Funding source category [1] 264761 0
Charities/Societies/Foundations
Name [1] 264761 0
RCH Foundation Grant (Number: 910038)
Address [1] 264761 0
Royal Children's Hospital Foundation,
Royal Children's Hospital,
Herston Road,
Herston,
QLD 4029
Country [1] 264761 0
Australia
Funding source category [2] 264762 0
Hospital
Name [2] 264762 0
Royal Children's Hospital and Health Service District
Address [2] 264762 0
Queensland Cerebral Palsy and Health Service District,
Level 1 Surgical Building,
Royal Children's Hospital,
Herston Road,
Herston
QLD 4029
Country [2] 264762 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital and Health Service District
Address
Queensland Cerebral Palsy and Health Service District,
Level 1 Surgical Building,
Royal Children's Hospital,
Herston Road,
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 263881 0
Other
Name [1] 263881 0
Cerebral Palsy League of Queensland
Address [1] 263881 0
Cerebral Palsy League of Queensland,
55, Oxlade Drive,
New Farm,
QLD 4005
Country [1] 263881 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266740 0
Queensland Children's Health Service (RCH) Human Research Ethics Committee
Ethics committee address [1] 266740 0
Level 3, RCH Foundation Building,
Royal Children's Hospital,
Herston,
QLD 4029
Ethics committee country [1] 266740 0
Australia
Date submitted for ethics approval [1] 266740 0
10/10/2008
Approval date [1] 266740 0
27/10/2008
Ethics approval number [1] 266740 0
2008/089
Ethics committee name [2] 266741 0
Cerebral Palsy League Human Research Ethics Committee
Ethics committee address [2] 266741 0
55, Oxlade Drive,
New Farm,
QLD 4005
Ethics committee country [2] 266741 0
Australia
Date submitted for ethics approval [2] 266741 0
10/10/2008
Approval date [2] 266741 0
13/10/2008
Ethics approval number [2] 266741 0
CPLQ2009/2010-1030
Ethics committee name [3] 266742 0
Townsville Health Service District Human Research Ethics Committee
Ethics committee address [3] 266742 0
PO Box 670,
Townsville,
QLD 4810
Ethics committee country [3] 266742 0
Australia
Date submitted for ethics approval [3] 266742 0
09/03/2010
Approval date [3] 266742 0
13/04/2010
Ethics approval number [3] 266742 0
HREC/10/QTHS/32

Summary
Brief summary
This single blinded randomised controlled trial aims to investigate the relative effectiveness of two models of physiotherapy rehabilitation post lower limb Botulinum Toxin A (BoNTA) injections. Traditional individual rehabilitation will be compared to a group-based model for children aged 4-14 years with Cerebral Palsy (CP) attending the Queensland Cerebral Palsy Health Service (QCPHS) for BoNTA injections.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32404 0
Mrs Rachel Thomas
Address 32404 0
Queensland Cerebral Palsy Health Service, Level 1 Surgical Building, Royal Children's Hospital, Herston Rd, Herston, QLD 4029
Country 32404 0
Australia
Phone 32404 0
+61 7 3636 5500
Fax 32404 0
Email 32404 0
rachel.thomas@health.qld.gov.au
Contact person for public queries
Name 15651 0
Mrs Rachel Thomas
Address 15651 0
Queensland Cerebral Palsy Health Service,
Level 1 Surgical Building,
Royal Children's Hospital,
Herston Rd,
Herston,
QLD 4029
Country 15651 0
Australia
Phone 15651 0
+61 7 3636 5500
Fax 15651 0
+61 7 3636 5480
Email 15651 0
rachel_thomas@health.qld.gov.au
Contact person for scientific queries
Name 6579 0
Ms Megan Kentish
Address 6579 0
Queensland Cerebral Palsy Health Service,
Level 1 Surgical Building,
Royal Children's Hospital,
Herston Rd,
Herston,
QLD 4029
Country 6579 0
Australia
Phone 6579 0
+61 7 3636 5500
Fax 6579 0
+61 7 3636 5480
Email 6579 0
megan_kentish@health.qld.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