Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000083998
Ethics application status
Not yet submitted
Date submitted
6/01/2011
Date registered
24/01/2011
Date last updated
24/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of below knee serial casting for calf contracture in ambulant boys with Duchenne muscular dystrophy.
Scientific title
A study of below knee serial casting for calf contracture in ambulant boys with Duchenne muscular dystrophy.
Secondary ID [1] 253281 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Duchenne muscular dystrophy 258807 0
tendoachilles contracture 258894 0
Condition category
Condition code
Neurological 258957 258957 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 259033 259033 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bilateral below knee serial casting using soft cast maximum of four sets of casts applied for up to two weeks total.
Intervention code [1] 257736 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259810 0
Reduce calf contracture and achieve a passive range of ankle dorsiflexion (DF) of at least plantigrade (90 degrees) assesed using goniometry.
Timepoint [1] 259810 0
baseline, 1month, 3months, 6months, 9months, 12months
Secondary outcome [1] 268612 0
Improve gait parameters including heel contact assessed with GAITRite electronic walkway, 6 minute walk test and timed functional tests.
Timepoint [1] 268612 0
baseline, 1month, 3months, 6months, 9months, 12months
Secondary outcome [2] 268613 0
Maintain or improve level of motor function assesed with North Star Ambulatory Assessment and timed functional tests.
Timepoint [2] 268613 0
baseline, 1month, 3months, 6months, 9months, 12months

Eligibility
Key inclusion criteria
- Aged 4 years or greater
- Independently ambulant over a distance of at least 75 metres and able to complete a 6 minute walk test
- With a measurable calf contracture (ie maximum PROM ankle dorsiflexion less than or equal to 0 degrees with the knee fully extended)
- With full passive knee extension or a knee flexion contracture less than 10 degrees
- With quadriceps lag less than 5 degrees
- With hip and knee flexor and extensor strength of at least grade 4 plus on manual muscle testing (Mendell and Florence 1990).
- Who are cognitively and emotionally able to cope with the treatment
- Whose family supports the treatment and undertakes to complete the protocol
Minimum age
4 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Aged under 4 years
- unable to ambulant 75 metres and unble to complete a 6 minute walk test
- passive knee extension or a knee flexion contracture greater than or equal to 10 degrees
- With quadriceps lag greater than 5 degrees
- With hip and knee flexor and extensor strength of less than grade 4 plus on manual muscle testing (Mendell and Florence 1990).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258201 0
Charities/Societies/Foundations
Name [1] 258201 0
Royal Children's Hospital Foundation
Country [1] 258201 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Flemington Rd
Parkville 3052
Victoria
Country
Australia
Secondary sponsor category [1] 257517 0
None
Name [1] 257517 0
Address [1] 257517 0
Country [1] 257517 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260185 0
Ethics committee address [1] 260185 0
Ethics committee country [1] 260185 0
Date submitted for ethics approval [1] 260185 0
22/12/2010
Approval date [1] 260185 0
Ethics approval number [1] 260185 0

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

Contacts
Principal investigator
Name 32007 0
Address 32007 0
Country 32007 0
Phone 32007 0
Fax 32007 0
Email 32007 0
Contact person for public queries
Name 15254 0
Dr Kate Carroll
Address 15254 0
Royal Children's Hospital
Neurosciences Centre
Flemington Rd
Parkville 3052
Victoria
Country 15254 0
Australia
Phone 15254 0
+61 3 9345 4287
Fax 15254 0
Email 15254 0
[email protected]
Contact person for scientific queries
Name 6182 0
Dr Monique Ryan
Address 6182 0
Royal Children's Hospital
Neurosciences Centre
Flemington Rd
Parkville 3052
Victoria
Country 6182 0
Australia
Phone 6182 0
+61 3 9345 5641
Fax 6182 0
Email 6182 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.