Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000631606
Ethics application status
Approved
Date submitted
29/05/2014
Date registered
13/06/2014
Date last updated
23/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognition and Bimanual Performance in Children with Unilateral Cerebral Palsy
Scientific title
Cognition and Bimanual Performance in Children with Unilateral Cerebral Palsy
Secondary ID [1] 284701 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 292054 0
Condition category
Condition code
Neurological 292390 292390 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Not applicable: Observational study. Eligible children will be assessed on a single occasion using a range of outcome measures relating to upper limb bimanual performance, motor planning, neuropsychological function and static magnetic resonance imaging (MRI).
Intervention code [1] 289489 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292253 0
Assisting Hand Assessment - Bimanual upper limb performance
Timepoint [1] 292253 0
Single occasion only. Cross sectional study
Primary outcome [2] 292254 0
Box and Blocks Test - Unilateral upper limb speed and dexterity
Timepoint [2] 292254 0
Single occasion only. Cross sectional study
Primary outcome [3] 292255 0
ABILHAND-Kids - Manual ability
Timepoint [3] 292255 0
Single occasion only. Cross sectional study
Secondary outcome [1] 308554 0
The “Sword Test” - Anticipatory motor planning
Timepoint [1] 308554 0
Single occasion only. Cross sectional study
Secondary outcome [2] 308555 0
Wechsler Intelligence Scale for Children (4th Ed) - Intelligence
Timepoint [2] 308555 0
Single occasion only. Cross sectional study
Secondary outcome [3] 308556 0
NEPSY-II - Executive function and attention, language, memory and learning, sensorimotor, visuospatial processing, social perception
Timepoint [3] 308556 0
Single occasion only. Cross sectional study
Secondary outcome [4] 308557 0
Test of Everyday Attention for Children (TEA-Ch) - Attention
Timepoint [4] 308557 0
Single occasion only. Cross sectional study
Secondary outcome [5] 308558 0
Tower of London - Executive functioning
Timepoint [5] 308558 0
Single occasion only. Cross sectional study
Secondary outcome [6] 308559 0
Sky Search DT - Sustained-divided attention
Timepoint [6] 308559 0
Single occasion only. Cross sectional study
Secondary outcome [7] 308560 0
Conners 3rd Edition - Everyday executive abilities
Timepoint [7] 308560 0
Single occasion only. Cross sectional study
Secondary outcome [8] 308561 0
The Behaviour Rating Inventory of Executive Function (BRIEF) – Parent Version - Parent ratings of current functional, emotional and behavioural manifestations of executive dysfunction.
Timepoint [8] 308561 0
Single occasion only. Cross sectional study
Secondary outcome [9] 308562 0
Automated Working Memory Assessment (AWMA) - Visuospatial working memory
Timepoint [9] 308562 0
Single occasion only. Cross sectional study
Secondary outcome [10] 308734 0
Static Magnetic Resonance Imaging - Type and severity of brain injury
Timepoint [10] 308734 0
Single occasion only. Cross sectional study

Eligibility
Key inclusion criteria
1. Diagnosis of congenital unilateral cerebral palsy as diagnosed and reported in the medical history by a medical specialist (i.e. neurologist, paediatrician);
2. Age 6 to 12 years at the time of recruitment.
3. Sufficient cooperation to complete the assessments (ie. Ascent).
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Upper limb surgery within 12 months of assessment.
2. Injection of Botulinum toxin-A within 3 months of assessment.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A sample size of 150 is sufficient to detect a minimum effect size of 0.12 (Cohen’s f2) with 10 predictors at 80% power and a probability level of 0.05.

Sample characteristics, including full cognitive functioning, motor functioning, demographic and data will be explored using descriptive data analysis. Descriptive data analyses will be completed by examining distributions and measures of the middle and spread in continuously scaled variables and by constructing frequency distributions for categorical variables.

Descriptive data analyses will be used to explore the data, and will be completed by examining distributions and measures of the middle and spread in continuously scaled variables and by constructing frequency distributions for categorical variables.

The primary hypothesis (a relationship exists among how well children with unilateral CP use their two hands together and aspects of their cognition function such as attention, goal setting, information processing and everyday executive abilities) will be assessed in two ways. To assess the association between and among bimanual upper limb motor performance (Assisting Hand Assessment) and measures of cognition, we will produce scatter plots and calculate correlation coefficients. We will examine the association between bimanual upper limb performance and cognition variable using univariable linear regression. Variables where there is a significant association with bimanual upper limb performance (p=0.1) will then be retained to be entered into a multivariable regression analysis adjusting for variables such as sex and age and others that could confound associations between bimanual upper limb performance and cognition.

Our second hypothesis (the relationship among cognition and bimanual hand function is influenced by underlying brain pathology) will be evaluated using logistic regression analysis because the outcome measurement is dichotomous (MRI lesion characteristics – as per protocol). We will examine the association between neuropathology (MRI), bimanual upper limb performance and cognitive variables. Variables where there is a significant association with neuropathology and bimanual upper limb performance (p=0.1) and neuropathology and cognitive variables (p=0.1) will be retained to be entered into a multivariable regression analysis adjusting for variables such as sex and age and other variables that could confound associations between the dependent variable and covariate.

All statistical analyses will be conducted on Stata V12.1 and led by a biostatistician with input from the clinical and research team.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2013
Actual
25/01/2013
Date of last participant enrolment
Anticipated
31/12/2014
Actual
14/08/2015
Date of last data collection
Anticipated
Actual
24/08/2015
Sample size
Target
150
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 2520 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 2521 0
Royal Children's Hospital - Herston
Recruitment hospital [3] 2523 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [4] 2524 0
Princess Margaret Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 289323 0
Charities/Societies/Foundations
Name [1] 289323 0
Cerebral Palsy International Research Foundation
Country [1] 289323 0
United States of America
Funding source category [2] 295409 0
Charities/Societies/Foundations
Name [2] 295409 0
Cerebral Palsy Alliance
Country [2] 295409 0
Australia
Primary sponsor type
Hospital
Name
Monash Children's Hospital
Address
246 Clayton Rd, Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 287992 0
None
Name [1] 287992 0
Address [1] 287992 0
Country [1] 287992 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291084 0
Monash Health
Ethics committee address [1] 291084 0
Ethics committee country [1] 291084 0
Australia
Date submitted for ethics approval [1] 291084 0
21/06/2012
Approval date [1] 291084 0
05/09/2012
Ethics approval number [1] 291084 0
12167B
Ethics committee name [2] 291085 0
Royal Children's Hospital, Melbourne
Ethics committee address [2] 291085 0
Ethics committee country [2] 291085 0
Australia
Date submitted for ethics approval [2] 291085 0
01/11/2012
Approval date [2] 291085 0
16/11/2012
Ethics approval number [2] 291085 0
32232 A
Ethics committee name [3] 291086 0
Royal Children's Hospital, Queensland
Ethics committee address [3] 291086 0
Ethics committee country [3] 291086 0
Australia
Date submitted for ethics approval [3] 291086 0
03/12/2012
Approval date [3] 291086 0
17/12/2012
Ethics approval number [3] 291086 0
HREC/121QRCHl218
Ethics committee name [4] 291087 0
Cerebral Palsy Alliance
Ethics committee address [4] 291087 0
Ethics committee country [4] 291087 0
Australia
Date submitted for ethics approval [4] 291087 0
03/12/2012
Approval date [4] 291087 0
30/12/2012
Ethics approval number [4] 291087 0
2012-12-03
Ethics committee name [5] 291149 0
Princess Margaret Hospital for Children
Ethics committee address [5] 291149 0
Ethics committee country [5] 291149 0
Australia
Date submitted for ethics approval [5] 291149 0
06/05/2013
Approval date [5] 291149 0
03/09/2013
Ethics approval number [5] 291149 0
2013062EP

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

Contacts
Principal investigator
Name 48838 0
Dr Brian Hoare
Address 48838 0
Monash Children's Hospital
246 Clayton Rd
Clayton, Victoria, 3168
Country 48838 0
Australia
Phone 48838 0
+61395944620
Fax 48838 0
Email 48838 0
[email protected]
Contact person for public queries
Name 48839 0
Brian Hoare
Address 48839 0
Monash Children's Hospital
246 Clayton Rd
Clayton, Victoria, 3168
Country 48839 0
Australia
Phone 48839 0
+61395944620
Fax 48839 0
Email 48839 0
[email protected]
Contact person for scientific queries
Name 48840 0
Brian Hoare
Address 48840 0
Monash Children's Hospital
246 Clayton Rd
Clayton, Victoria, 3168
Country 48840 0
Australia
Phone 48840 0
+61395944620
Fax 48840 0
Email 48840 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
SourceTitleYear of PublicationDOI
EmbaseWindmill-task as a New Quantitative and Objective Assessment for Mirror Movements in Unilateral Cerebral Palsy: A Pilot Study.2018https://dx.doi.org/10.1016/j.apmr.2018.01.035
N.B. These documents automatically identified may not have been verified by the study sponsor.