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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01744158
Registration number
NCT01744158
Ethics application status
Date submitted
21/08/2012
Date registered
6/12/2012
Date last updated
6/12/2012
Titles & IDs
Public title
Exploring Hypertonia in Children With Cerebral Palsy
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Scientific title
Exploring Hypertonia in Children With Cerebral Palsy- a Population-based Approach.
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Secondary ID [1]
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REC2202/8/12
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Universal Trial Number (UTN)
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Trial acronym
HypE-CP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy.
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - No intervention applicable
Children with cerebral palsy - No intervention applicable
Other interventions: No intervention applicable
Following consent, children will undergo a comprehensive assessment performed by a research team including rehabilitation paediatrician and therapist. Hypertonia and abnormal movements will be assessed by a pediatrician with expertise in treating children with movement disorders. The assessments will be performed at a rehabilitation clinic, or child's home, and will include:
differentiation of hypertonia by application of the Hypertonia Assessment Tool-Discriminate (HAT-D)
measurement of severity of dystonia using the Barry Albright dystonia scale, based on video recording
measurement of severity of spasticity using the modified Ashworth score
description of presence of chorea or athetosis
classification of gross motor abilities using the GMFCS and functional mobility scale (FMS)
classification of fine motor abilities using the manual ability classification system (MACS)
collection of demographic data and associated medical history
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Hypertonia Assessment Tool-Discriminate (HAT-D)
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Assessment method [1]
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The Hypertonia Assessment Tool (HAT) is a seven-item standardised clinical assessment tool used to differentiate the various types of paediatric hypertonia. There are 2 spasticity items, 2 rigidity items and 3 dystonia items and a standardized protocol for administration has been developed. Each item is scored yes or no. A positive score for at least one item of the subgroup confirms the presence of the subtype of hypertonia in the limb examined.
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Timepoint [1]
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One hour
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Primary outcome [2]
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Barry-Albright Dystonia scale
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Assessment method [2]
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The Barry-Albright Dystonia scale is a 5-point criterion-based ordinal scale for measuring dystonia in CP, with sound validity and reliability. 7 It assesses dystonia in 8 body regions: eyes, mouth, neck, trunk, and the 4 extremities. Severity is scored from none to severe, with each body region having specific descriptors for scoring.
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Timepoint [2]
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One hour
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Secondary outcome [1]
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Modified Ashworth Scale
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Assessment method [1]
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The Modified Ashworth scale is a 6-point ordinal scale of muscle tone and involves a subjective assessment of muscle resistance as a limb is moved trough its full passive range.
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Timepoint [1]
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One hour
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Eligibility
Key inclusion criteria
- children with a confirmed diagnosis of cerebral palsy
- aged between 2 and 18 years
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Minimum age
2
Years
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Maximum age
18
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- presence of any progressive neurological disorder, including forms of genetic dystonia
- children less than two years, or greater than 18 years of age
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2014
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Women's and Children's Hospital - Adelaide
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Recruitment postcode(s) [1]
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5006 - Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
Women's and Children's Hospital, Australia
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Allergan Australia Pty Ltd
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Abnormal limb and trunk movements are seen in many children with cerebral palsy. Recognizing
the difference between types of these movements is not well understood. This study aims to
describe how common are these movements in children recruited from a population-based sample
of children identified on a cerebral palsy register, and to explore associations with motor
abilities. It is hoped this will lead to improved understanding and recognition of movement
disorders in CP, to allow clinicians to choose appropriate treatments. We hypothesise that
the underlying prevalence of dyskinesia is higher than that previously identified through
conventional motor descriptions in cerebral palsy populations in Australia, and may approach
20%.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01744158
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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James E Rice, MD
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Address
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Women's and Children's Health Network
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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James E Rice, MD
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Address
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Country
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Phone
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+618 8161 7367
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01744158
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