Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000054011
Ethics application status
Approved
Date submitted
6/01/2010
Date registered
18/01/2010
Date last updated
27/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Clinical Characteristics of Children with Generalised Joint Hypermobility and thier Relationship to Adverse Outcomes
Scientific title
An observational study of the Clinical Characteristics of Children with Generalised Joint Hypermobility and thier Relationship to Adverse Outcomes
Secondary ID [1] 1248 0
none
Universal Trial Number (UTN)
Trial acronym
Sydney Hypermobility Cohort
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Joint Hypermobility
Ehlers Danlos Syndrome (hypermobile type) 256482 0
Condition category
Condition code
Musculoskeletal 256650 256650 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 256651 256651 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of natural history of pain, soft tissue injuries and fatigue symptoms as well as multisystemic involvement and function over 5 years. Main exposure is beighton score >=4/9 main outcome is disability measured by participation in physical activity, 6 minute walk test and HRQOL
Intervention code [1] 255770 0
Not applicable
Comparator / control treatment
general population - age matched from SPANS (booth et al 2004)
Control group
Historical

Outcomes
Primary outcome [1] 257548 0
Disability
function - mobility from 6 minute walk test
participation - self reported physical activity questionnaire
global wellbeing - health related quality of life from Peds QL
Timepoint [1] 257548 0
5 years post recruitment
Secondary outcome [1] 262792 0
fatigue as a result of condition from fatigue module Peds QL
Timepoint [1] 262792 0
5 years post recruitment
Secondary outcome [2] 262793 0
pain as a result of condition from pain module Peds QL (Paediatric Quality of Life Inventory) and VAS (visual analogue scales)
Timepoint [2] 262793 0
5 years post recruitment

Eligibility
Key inclusion criteria
Beighton Hypermobility Score of 4 or more of 9
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severe connective tissue disease

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
1/03/2007
Date of last participant enrolment
Anticipated
Actual
20/12/2013
Date of last data collection
Anticipated
1/12/2017
Actual
1/12/2017
Sample size
Target
150
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 2097 0
Childrens Hospital at westmead
Recruitment hospital [2] 2098 0
Sydney Children's Hospital - Randwick

Funding & Sponsors
Funding source category [1] 256255 0
Self funded/Unfunded
Name [1] 256255 0
Country [1] 256255 0
Funding source category [2] 288741 0
Charities/Societies/Foundations
Name [2] 288741 0
Arthritis Australia
Country [2] 288741 0
Australia
Primary sponsor type
Hospital
Name
Childrens Hospital at Westmead
Address
Locked bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 251586 0
None
Name [1] 251586 0
Address [1] 251586 0
Country [1] 251586 0
Other collaborator category [1] 279026 0
Individual
Name [1] 279026 0
A/prof Leslie Nicholson
Address [1] 279026 0
Discipline of Biomedical Science, School of Medical Sciences, Sydney Medical School
THE UNIVERSITY OF SYDNEY
L122, Cumberland Campus C42
East St (PO Box 170)
Lidcombe NSW 1825
Country [1] 279026 0
Australia
Other collaborator category [2] 279027 0
Individual
Name [2] 279027 0
Dr Roger Adams
Address [2] 279027 0
Discipline of Physiotherapy,

THE UNIVERSITY OF SYDNEY
L122, Cumberland Campus C42
East St (PO Box 170)
Lidcombe NSW 1825
Country [2] 279027 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258347 0
The Childrens Hospital at Westmead
Ethics committee address [1] 258347 0
Ethics Comittee
Research and Development
the childrens hoapital at westmead
locked bag 4001
westmead NSW 2145
Ethics committee country [1] 258347 0
Australia
Date submitted for ethics approval [1] 258347 0
08/11/2006
Approval date [1] 258347 0
05/02/2007
Ethics approval number [1] 258347 0

Summary
Brief summary
Longitudinal Cohort study of outcomes in children with Joint hypermobility and the relationships between signs and symptoms, function, participation and outcomes.
Trial website
n/a
Trial related presentations / publications
Tofts LJ, Elliott EJ, Munns C, Pacey V, Sillence DO. The Differential diagnosis of hypermobility a review of the literature Paed Rheum 2009 7(1)

Pacey V, Adams RD, Tofts L, Munns CF, Nicholson LL. Joint hypermobility syndrome subclassification in paediatrics: a factor analytic approach. Archives of disease in childhood. Jan 2015;100(1):8-13.

Pacey V, Tofts L, Adams RD, Munns CF, Nicholson LL. Quality of life prediction in children with joint hypermobility syndrome. J Paediatr Child Health. 2015 Jan 26. doi: 10.1111/jpc.12826.

Pacey V, Tofts L, Wesley A, Collins F, Singh-Grewal D. Joint hypermobility syndrome: A review for clinicians. J Paediatr Child Health. 2014 Oct 7. doi: 10.1111/jpc.12731
Public notes

Contacts
Principal investigator
Name 30670 0
Dr Verity Pacey
Address 30670 0
Kids Rehab
Childrens Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 30670 0
Australia
Phone 30670 0
+61298452132
Fax 30670 0
Email 30670 0
[email protected]
Contact person for public queries
Name 13917 0
Dr Louise Tofts
Address 13917 0
Rehabilitation Department
The Childrens Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 13917 0
Australia
Phone 13917 0
+61298452132
Fax 13917 0
+61298450685
Email 13917 0
[email protected]
Contact person for scientific queries
Name 4845 0
Dr Louise Tofts
Address 4845 0
Rehabilitation Department
The Childrens Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 4845 0
Australia
Phone 4845 0
+61298452132
Fax 4845 0
+61298450685
Email 4845 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.