Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000458932
Ethics application status
Approved
Date submitted
10/04/2011
Date registered
4/05/2011
Date last updated
4/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quality of Life in Boys with Duchenne Muscular Dystrophy
Scientific title
Activity Limitation Study and Quality of Life in Boys with Duchenne muscular dystrophy
Secondary ID [1] 259961 0
Nil
Universal Trial Number (UTN)
U1111-1120-6605
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Duchenne Muscular Dystrophy 265589 0
Condition category
Condition code
Musculoskeletal 265744 265744 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessment of activity limitation and quality of life. The subjects were evaluated in a single day. To assess the activity limitations, we used the manual test of strength in the flexor muscles of the shoulder, elbow flexors, wrist flexors, hip flexors, knee extensors and dorsiflexors.
The scales of measurement limitations were EK and FIM. To assess the quality of life, AUQEI validated questionnaire was used. In each patient the time of the evaluation lasted approximately 40 minutes.
Intervention code [1] 264373 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266493 0
Functional status measured by
EK (Egen Klassifikation)
FIM (Functional Independence Measure)
Force measure (Medical Research Council scale)
Timepoint [1] 266493 0
In the start of the study.
Primary outcome [2] 266494 0
Quality of Life - AUQEI (Autoquestionnaire Qualite de Vie Enfant Image)
Timepoint [2] 266494 0
In the start of the study.
Secondary outcome [1] 273893 0
Nil
Timepoint [1] 273893 0
Nil

Eligibility
Key inclusion criteria
Definitive diagnosis of DMD
Signing the consent form
Subjects over 4 years old
Minimum age
4 Years
Maximum age
14 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
No definitive diagnosis of DMD
Subjects under 4 years old
Cognitive deficit

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3347 0
Brazil
State/province [1] 3347 0

Funding & Sponsors
Funding source category [1] 264846 0
University
Name [1] 264846 0
Federal University of Rio de Janeiro
Country [1] 264846 0
Brazil
Funding source category [2] 264847 0
Hospital
Name [2] 264847 0
Instituto de Puericultura e Pediatria Martagao Gesteira,
Country [2] 264847 0
Brazil
Funding source category [3] 264849 0
Hospital
Name [3] 264849 0
Hospital Universitario Clementino Fraga Filho
Country [3] 264849 0
Brazil
Primary sponsor type
Individual
Name
Fabio Luis Feitosa Fonseca
Address
Av. TenCel Muniz de Aragao, 898
CEP: 22765-005
Country
Brazil
Secondary sponsor category [1] 263946 0
None
Name [1] 263946 0
Address [1] 263946 0
Country [1] 263946 0
Other collaborator category [1] 251934 0
University
Name [1] 251934 0
Instituto Federal de Educacao, Ciencia e Tecnologia do Rio de Janeiro
Address [1] 251934 0
Rua Carlos Wenceslau, 343 - Realengo - Rio de Janeiro - RJ - CEP: 21715-000
Country [1] 251934 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266810 0
Comite de Etica e Pesquisa IPPMG
Ethics committee address [1] 266810 0
Ethics committee country [1] 266810 0
Brazil
Date submitted for ethics approval [1] 266810 0
15/01/2008
Approval date [1] 266810 0
19/02/2008
Ethics approval number [1] 266810 0
66/07

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

Contacts
Principal investigator
Name 32462 0
Address 32462 0
Country 32462 0
Phone 32462 0
Fax 32462 0
Email 32462 0
Contact person for public queries
Name 15709 0
Fabio Luis Feitosa Fonseca
Address 15709 0
Av. Tenente Coronel Muniz de Aragao, 898 / bl 1 / apto 404
CEP 22765-005
Country 15709 0
Brazil
Phone 15709 0
+55 21 25016751
Fax 15709 0
Email 15709 0
[email protected]
Contact person for scientific queries
Name 6637 0
Fabio Luis Feitosa Fonseca
Address 6637 0
Av. Tenente Coronel Muniz de Aragao, 898 / bl 1 / apto 404
CEP 22765-005
Country 6637 0
Brazil
Phone 6637 0
+55 21 25016751
Fax 6637 0
Email 6637 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.