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
ACTRN12605000126617
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
Upper limb functional assessment in children with hemiplegic cerebral palsy: a descriptive study
Scientific title
Upper limb functional assessment in children with hemiplegic cerebral palsy: a descriptive study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemiplegic cerebral palsy 214 0
Condition category
Condition code
Neurological 240 240 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None
Intervention code [1] 152 0
None
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286 0
Assessment of motor and processing skills (AMPS)
Timepoint [1] 286 0
Baseline
Secondary outcome [1] 630 0
Neurorehabiltation examination
Timepoint [1] 630 0
Baseline
Secondary outcome [2] 631 0
Pediatric evaluation of disability inventory (PEDI)
Timepoint [2] 631 0
Baseline
Secondary outcome [3] 632 0
Pediatric quality of life (PEDSQoL)
Timepoint [3] 632 0
Baseline
Secondary outcome [4] 633 0
Child self-perception profile
Timepoint [4] 633 0
Baseline
Secondary outcome [5] 634 0
Pain scale
Timepoint [5] 634 0
Baseline
Secondary outcome [6] 635 0
Rehabilitation management questionnaire.
Timepoint [6] 635 0
Baseline

Eligibility
Key inclusion criteria
Children aged between 3-16 years of age with a diagnosis of hemiplegic cerebral palsy. Registered on the South Australian Cerebral Palsy register.
Minimum age
3 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other forms of cerebral palsy.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
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
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 299 0
Charities/Societies/Foundations
Name [1] 299 0
Financial Markets Foundation for Children
Country [1] 299 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] 232 0
None
Name [1] 232 0
None
Address [1] 232 0
Country [1] 232 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1169 0
Flinders University/Flinders Medical Centre
Ethics committee address [1] 1169 0
Ethics committee country [1] 1169 0
Australia
Date submitted for ethics approval [1] 1169 0
Approval date [1] 1169 0
Ethics approval number [1] 1169 0
Ethics committee name [2] 1170 0
Women's and Children's Hospital
Ethics committee address [2] 1170 0
Ethics committee country [2] 1170 0
Australia
Date submitted for ethics approval [2] 1170 0
Approval date [2] 1170 0
Ethics approval number [2] 1170 0

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

Contacts
Principal investigator
Name 35548 0
Address 35548 0
Country 35548 0
Phone 35548 0
Fax 35548 0
Email 35548 0
Contact person for public queries
Name 9341 0
Prof. Maria Crotty
Address 9341 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9341 0
Australia
Phone 9341 0
+61 8 82751103
Fax 9341 0
+61 8 82751130
Email 9341 0
[email protected]
Contact person for scientific queries
Name 269 0
Prof. Maria Crotty
Address 269 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 269 0
Australia
Phone 269 0
+61 8 82751103
Fax 269 0
+61 8 82751130
Email 269 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.