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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Timepoint [1] 0 0
One hour
Primary outcome [2] 0 0
Barry-Albright Dystonia scale
Timepoint [2] 0 0
One hour
Secondary outcome [1] 0 0
Modified Ashworth Scale
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
Sex
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
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2014
Actual
Sample size
Target
300
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
Government body
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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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