Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000119493
Ethics application status
Approved
Date submitted
20/10/2006
Date registered
9/02/2007
Date last updated
22/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapy Intensity after BOTOX®
Scientific title
Comparing of Three Different Physiotherapy and Occupational Therapy Intensities Post Botulinum Toxin Injections for Children with Cerebral Palsy for Achieving Family Goal Outcomes
Secondary ID [1] 289067 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 1611 0
Condition category
Condition code
Neurological 1716 1716 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 1717 1717 0 0
Physiotherapy
Physical Medicine / Rehabilitation 1718 1718 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapy and Occupational Therapy. Group 1 will receive intense hands-on therapy 3 times per week for 4 weeks, then take a 4 week break with no therapy then repeat the 4 weeks intense therapy 3 times per week (12 weeks duration). Group 2 will receive regular therapy, 1 times per week for 4 weeks, then fortnightly for 4 weeks, then monthly (12 weeks duration). Group 3 will receive a individualised home program with 2 support appointments to be carried out for 12 weeks duration.
Intervention code [1] 1417 0
Rehabilitation
Comparator / control treatment
As above
Control group
Active

Outcomes
Primary outcome [1] 2387 0
Performance and Satisfaction scores as measured on the Canadian Occupational Performance Measure.
Timepoint [1] 2387 0
Baseline, 4, 8, 12, 16 weeks
Secondary outcome [1] 4150 0
Goal achievement T-Score as measured on the Goal Attainment Scale.
Timepoint [1] 4150 0
Baseline, 4, 8, 12, 16 weeks

Eligibility
Key inclusion criteria
1. Diagnosis of cerebral palsy 2. Have received BOTOX® in the last 4 weeks from one of the children’s hospitals 3. Eligible for services from The Spastic Centre 4. Functional ability to use the affected limb/s for at least assisted ambulation, or attempts to grip a palm sized toy on request OR of BOTOX® was given for reduction of caregiver burden 5. Informed consent is given.
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis is not cerebral palsy2. Botulinum toxin is injected greater than 4 weeks prior to enrollment3. Consent is not given4. Client is not eligible for standard therapy services from The Spastic Centre of NSW.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation (sequence generation) using block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participants and evaluators are blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
15/05/2006
Actual
16/05/2006
Date of last participant enrolment
Anticipated
Actual
18/02/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 1866 0
Other
Name [1] 1866 0
Cerebral Palsy Institute
Country [1] 1866 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Spastic Centre of NSW, Sydney
Address
PO Box 6427
Frenchs Forest
NSW 2086
Country
Australia
Secondary sponsor category [1] 1683 0
None
Name [1] 1683 0
N/A
Address [1] 1683 0
Country [1] 1683 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3475 0
The Spastic Centre HREC
Ethics committee address [1] 3475 0
Ethics committee country [1] 3475 0
Australia
Date submitted for ethics approval [1] 3475 0
Approval date [1] 3475 0
15/03/2006
Ethics approval number [1] 3475 0
EC00402

Summary
Brief summary
Cerebral palsy is the most common physical disability in childhood, with a significant lifelong impact on the person, their family and the community. It is estimated that 1:400 children are born with cerebral palsy (Stanley et al, 2000), with over 600 new cases diagnosed in Australia each year. At present there is no known cure for this condition (Stanley et al, 2000) however the methods for the treatment of its symptoms, such as muscle spasticity, are well documented. It is known that the combination of occupational therapy along with botulinum toxin (BOTOX) injections (Lowe, Novak & Cusick, 2005; Wallen, O’Flaherty & Waugh 2004) and best-practice home programs (Novak, Cusick & Lowe, 2005) can produce positive outcomes for improving function and manage the symptoms of spasticity in children with cerebral palsy (Corry & Graham, 1994; Delago, 2002; Leach, 1997; Russman, Tilton & Gromley, 1997). It is therefore worth investigating the nature and extent of parental input and determine whether or not intensive provider delivered therapy intervention following upper limb botulinum toxin injections will lead to greater desirable outcome in the daily functioning of a child with cerebral palsy. The results of this research project will provide valuable data for determining therapy intensity and the conditions and processes that affect the treatment process. This will help inform decisions by health professionals and families regarding the type, amount, model and method of therapy to be used following BOTOX® injections, thus guiding best practice, use of time, resources and funding in the treatment of spasticity in children with cerebral palsy. There is thus a clear gap in research literature regarding provider-based intense therapy effectiveness that needs to be filled.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27351 0
Prof Iona Novak
Address 27351 0
Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest 2086
NSW
Country 27351 0
Australia
Phone 27351 0
+61409078917
Fax 27351 0
Email 27351 0
[email protected]
Contact person for public queries
Name 10606 0
Prof Iona Novak
Address 10606 0
Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest 2086
NSW
Country 10606 0
Australia
Phone 10606 0
+61409078917
Fax 10606 0
Email 10606 0
[email protected]
Contact person for scientific queries
Name 1534 0
Prof Iona Novak
Address 1534 0
Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest 2086
NSW
Country 1534 0
Australia
Phone 1534 0
+61409078917
Fax 1534 0
Email 1534 0
[email protected]

No information has been provided regarding IPD availability


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.