Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000385640
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
13/09/2005
Date last updated
13/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The relationship between nutrition and quality of life for lower limb amputees
Scientific title
The nutritional health and quality of life among lower limb amputees attending the orthotic and prosthetic clinic at the Repatriation General Hospital
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb amputation 489 0
Condition category
Condition code
Other 568 568 0 0

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None
Intervention code [1] 438 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 651 0
Relationship between nutritional status and quality of life
Timepoint [1] 651 0
Secondary outcome [1] 1347 0
Mini Nutritional Assessment
Timepoint [1] 1347 0
Secondary outcome [2] 1348 0
Anthropometry
Timepoint [2] 1348 0
Secondary outcome [3] 1349 0
Assessment of Quality of Life
Timepoint [3] 1349 0
Secondary outcome [4] 1350 0
Prosthesis Evaluation Questionnaire
Timepoint [4] 1350 0
Secondary outcome [5] 1351 0
Short Form 36 questionnaire
Timepoint [5] 1351 0

Eligibility
Key inclusion criteria
Attending the outpatient clinic during the trial period, lower limb amputation above ankle height, able to read and speak english.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 619 0
Self funded/Unfunded
Name [1] 619 0
Country [1] 619 0
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Country
Secondary sponsor category [1] 504 0
None
Name [1] 504 0
None
Address [1] 504 0
Country [1] 504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1735 0
Repatriation General Hospital
Ethics committee address [1] 1735 0
Ethics committee country [1] 1735 0
Australia
Date submitted for ethics approval [1] 1735 0
Approval date [1] 1735 0
Ethics approval number [1] 1735 0

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

Contacts
Principal investigator
Name 35813 0
Address 35813 0
Country 35813 0
Phone 35813 0
Fax 35813 0
Email 35813 0
Contact person for public queries
Name 9627 0
Professor Maria Crotty
Address 9627 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9627 0
Australia
Phone 9627 0
+61 8 82751103
Fax 9627 0
+61 8 82751130
Email 9627 0
maria.crotty@rgh.sa.gov.au
Contact person for scientific queries
Name 555 0
Professor Maria Crotty
Address 555 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 555 0
Australia
Phone 555 0
+61 8 82751103
Fax 555 0
+61 8 82751130
Email 555 0
maria.crotty@rgh.sa.gov.au

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.