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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Exploring Hypertonia in Children With Cerebral Palsy- a Population-based Approach.
Secondary ID [1] 0 0
REC2202/8/12
Universal Trial Number (UTN)
Trial acronym
HypE-CP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy. 0 0
Condition category
Condition code
Neurological 0 0 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
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hypertonia Assessment Tool-Discriminate (HAT-D) - 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.
Timepoint [1] 0 0
One hour
Primary outcome [2] 0 0
Barry-Albright Dystonia scale - 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.
Timepoint [2] 0 0
One hour
Secondary outcome [1] 0 0
Modified Ashworth Scale - 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.
Timepoint [1] 0 0
One hour

Eligibility
Key inclusion criteria
- children with a confirmed diagnosis of cerebral palsy

- aged between 2 and 18 years
Minimum age
2 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Women's and Children's Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5006 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Women's and Children's Hospital, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Allergan Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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%.
Trial website
https://clinicaltrials.gov/show/NCT01744158
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James E Rice, MD
Address 0 0
Women's and Children's Health Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
James E Rice, MD
Address 0 0
Country 0 0
Phone 0 0
+618 8161 7367
Fax 0 0
Email 0 0
james.rice@health.sa.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01744158