Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000127606
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
11/08/2005
Date last updated
22/01/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Botulinum toxin A and the neglected upper limb in children with hemiplegic cerebral palsy
Scientific title
The use of the assessment of motor and process skills (AMPS) in detecting a change in participation level function after botulinum toxin A injection in the upper limb of children with hemiplegic cerebral palsy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemiplegic cerebral palsy 215 0
Condition category
Condition code
Neurological 241 241 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Botulinum toxin A (Botox) injection into the affected upper limb followed by 4 weeks of intensive occupational therapy (intervention)
Intervention code [1] 153 0
Treatment: Drugs
Comparator / control treatment
Intensive occupational therapy alone (control)
Control group
Active

Outcomes
Primary outcome [1] 287 0
Assessment of motor and process skills (AMPS)
Timepoint [1] 287 0
At baseline, one month, three months, and six months.
Secondary outcome [1] 636 0
Neurorehabiltation examination
Timepoint [1] 636 0
Baseline, 1, 3, 6 months
Secondary outcome [2] 637 0
Pediatric quality of life (PEDSQoL)
Timepoint [2] 637 0
Baseline 3, 6, 12 months
Secondary outcome [3] 638 0
Pain scale
Timepoint [3] 638 0
Baseline, 1, 3, 6 months
Secondary outcome [4] 639 0
Child self perception profile
Timepoint [4] 639 0
Baseline, 3, 6 months
Secondary outcome [5] 640 0
Economic evaluation questionnaire
Timepoint [5] 640 0
Baseline, 3, 6, 12 months
Secondary outcome [6] 641 0
Goal attainment scale (GAS)
Timepoint [6] 641 0
Baseline, 1, 3, 6, 12 months
Secondary outcome [7] 642 0
Pediatric evaluation of disability inventory (PEDI)
Timepoint [7] 642 0
Baseline, 3, 6, 12 months
Secondary outcome [8] 643 0
Child health questionnaire
Timepoint [8] 643 0
Baseline, 3, 6, 12 months
Secondary outcome [9] 644 0
Lifestyle assessment questionnaire
Timepoint [9] 644 0
Baseline, 12 months
Secondary outcome [10] 645 0
Rehabilitation management questionnaire
Timepoint [10] 645 0
Baseline, 1, 3, 6, 12 months

Eligibility
Key inclusion criteria
Children aged between 3-16 years of aged diagnosed with hemiplegic cerebral palsy, registered on the South Australian Cerebral Palsy register, elbow extension to neutral, wrist extension to 30 degrees past neutral with fingers extended, supination of forearm to 30 degrees past neutral, thumb extension to neutral, can initiate finger movements, tone on a modified Ashworth Scale >= 2/4 in at least one upper limb joint.
Minimum age
3 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infection at the proposed injection site, Myasthenia Gravis, Eaton Lambert Syndrome, botulinum toxin A injection in a lower limb within the previous 6 months or upper limb within the previous 12 months.

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 concealed in sealed opaque envelopes and revealed to the investigator by a person external to the study investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated table of random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 300 0
Charities/Societies/Foundations
Name [1] 300 0
Financial Markets Foundation for Children,
Country [1] 300 0
Australia
Funding source category [2] 301 0
Commercial sector/Industry
Name [2] 301 0
Allergan Australia
Country [2] 301 0
Australia
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Department of Rehabilitation and Aged Care Flinders University Repatriation General Hospital Daws Rd Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 233 0
None
Name [1] 233 0
None
Address [1] 233 0
Country [1] 233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1171 0
Flinders University/Flinders Medical Centre
Ethics committee address [1] 1171 0
Ethics committee country [1] 1171 0
Australia
Date submitted for ethics approval [1] 1171 0
Approval date [1] 1171 0
Ethics approval number [1] 1171 0
Ethics committee name [2] 1172 0
Women's and Children's Hospital
Ethics committee address [2] 1172 0
Ethics committee country [2] 1172 0
Australia
Date submitted for ethics approval [2] 1172 0
Approval date [2] 1172 0
Ethics approval number [2] 1172 0

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

Contacts
Principal investigator
Name 35700 0
Address 35700 0
Country 35700 0
Phone 35700 0
Fax 35700 0
Email 35700 0
Contact person for public queries
Name 9342 0
Prof. Maria Crotty
Address 9342 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9342 0
Australia
Phone 9342 0
+61 8 82751103
Fax 9342 0
+61 8 82751130
Email 9342 0
[email protected]
Contact person for scientific queries
Name 270 0
Prof. Maria Crotty
Address 270 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 270 0
Australia
Phone 270 0
+61 8 82751103
Fax 270 0
+61 8 82751130
Email 270 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.