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
Duchenne muscular dystrophy is a progressive disorder which affects muscle strength in boys and results in the loss of the ability to walk between 9 and 13 years of age. Along with muscle weakness the boys often also experience muscle tightness, particularly in their calf muscles. This in turn causes them to walk on their toes, which makes standing and walking balance more precarious.
Boys with DMD undertake physiotherapy prescribed stretching programs and use night splinting to address this muscle tightness but commonly these are not sufficient to overcome the muscle shortening. Surgical lengthening has been shown to have a beneficial effect on ankle contracture in boys with DMD. This is very invasive and has not been shown to be associated with any improvement in strength or function. Below knee serial casting is used in some overseas centres as a treatment option for calf shortening.

This project aims to assess the effectiveness of below knee serial casting on the length of calf muscles and walking ability in boys with DMD. We hope to assess whether short periods of serial casting will maintain calf muscle length, improve gait, and maintain or improve motor function. The boy’s gait, muscle length and motor function will be assessed before and after serial casting and then at 3 monthly intervals for a twelve month period.
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
kate.carroll@rch.org.au
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
monique.ryan@rch.org.au

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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
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