Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000011684
Ethics application status
Approved
Date submitted
14/07/2005
Date registered
15/07/2005
Date last updated
13/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Night casting and stretching to improve function in people with Charcot-Marie-Tooth disease
Scientific title
Night casting and stretching to improve function in people with Charcot-Marie-Tooth disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Charcot-Marie-Tooth disease 73 0
Condition category
Condition code
Human Genetics and Inherited Disorders 87 87 0 0
Other human genetics and inherited disorders
Neurological 88 88 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Night casting and stretching group: removable plaster casts worn at night for 8 hours, every night for 4 weeks. Night casting is followed by a daily stretching program, conducted at home for 4 weeks.
Comparator / control treatment
Usual care group: usual acitvites are maintained for 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 117 0
The subject's ability to perform functional tasks will be measured using the Patient Specific Functional Scale.
Timepoint [1] 117 0
Measured at baseline, and again after 4 weeks and 8 weeks.
Secondary outcome [1] 273 0
Ankle dorsiflexion range of motion
Timepoint [1] 273 0
Assessed at baseline, and again after 4 weeks and 8 weeks
Secondary outcome [2] 274 0
Walking velocity
Timepoint [2] 274 0
Assessed at baseline, and again after 4 weeks and 8 weeks
Secondary outcome [3] 275 0
Balance
Timepoint [3] 275 0
Assessed at baseline, and again after 4 weeks and 8 weeks
Secondary outcome [4] 276 0
Stair-climbing ability and foot posture
Timepoint [4] 276 0
Assessed at baseline, and again after 4 weeks and 8 weeks

Eligibility
Key inclusion criteria
Charcot-Marie-Tooth disease of any type; aged 7-20 years; restricted dorsiflexion range of motion
Minimum age
7 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgery to foot or ankle, recent ankle sprain or fracture to either foot, stretching program within last 2 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
centrally generated and managed via telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated by computer program. No stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 124 0
Charities/Societies/Foundations
Name [1] 124 0
Australian Podiatry Education and Research Foundation
Country [1] 124 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW
Country
Australia
Secondary sponsor category [1] 90 0
Hospital
Name [1] 90 0
Children's Hospital at Westmead
Address [1] 90 0
Hawkesbury Rd
Westmead NSW 2145
Country [1] 90 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 879 0
University of Sydney and Children's Hospital at Westmead
Ethics committee address [1] 879 0
Ethics committee country [1] 879 0
Australia
Date submitted for ethics approval [1] 879 0
Approval date [1] 879 0
Ethics approval number [1] 879 0

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

Contacts
Principal investigator
Name 35355 0
Address 35355 0
Country 35355 0
Phone 35355 0
Fax 35355 0
Email 35355 0
Contact person for public queries
Name 9209 0
Dr Jacqui Raymond
Address 9209 0
School of Physiotherapy
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 9209 0
Australia
Phone 9209 0
+61 2 93519385
Fax 9209 0
+61 2 93519601
Email 9209 0
[email protected]
Contact person for scientific queries
Name 137 0
Professor Kathryn Refshauge
Address 137 0
School of Physiotherapy
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 137 0
Australia
Phone 137 0
+61 2 93519262
Fax 137 0
+61 2 93519601
Email 137 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.