Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000104651
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
9/08/2005
Date last updated
14/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do amputees accurately report how much they use their lower-limb prosthesis?
Scientific title
Comparison of self reported vs actual activity levels amongst lower limb amputees: An observational study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb amputation 186 0
Condition category
Condition code
Other 211 211 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None
Intervention code [1] 114 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 249 0
Correlation between self reported activity and measured activity recorded over a one week period
Timepoint [1] 249 0
One week follow-up
Secondary outcome [1] 570 0
Locomotor Capabilities Index
Timepoint [1] 570 0
Baseline
Secondary outcome [2] 571 0
Assessment of Quality of Life
Timepoint [2] 571 0
One week follow-up
Secondary outcome [3] 572 0
Prosthesis Evaluation Questionnaire
Timepoint [3] 572 0
At baseline.

Eligibility
Key inclusion criteria
Lower limb amputation at least 6 months rehabilitation, cognitively able to complete questionnaires and activity diary.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to ambulate with prosthesis.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270 0
Self funded/Unfunded
Name [1] 270 0
Country [1] 270 0
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Department of Rehabilitation and Aged Care Flinders University Repatriation General Hospital Daws Rd Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 204 0
None
Name [1] 204 0
None
Address [1] 204 0
Country [1] 204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1102 0
Repatriation General Hospital
Ethics committee address [1] 1102 0
Ethics committee country [1] 1102 0
Australia
Date submitted for ethics approval [1] 1102 0
Approval date [1] 1102 0
Ethics approval number [1] 1102 0

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

Contacts
Principal investigator
Name 35461 0
Address 35461 0
Country 35461 0
Phone 35461 0
Fax 35461 0
Email 35461 0
Contact person for public queries
Name 9303 0
Prof. Maria Crotty
Address 9303 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9303 0
Australia
Phone 9303 0
+61 8 82751103
Fax 9303 0
+61 8 82751130
Email 9303 0
[email protected]
Contact person for scientific queries
Name 231 0
Prof. Maria Crotty
Address 231 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 231 0
Australia
Phone 231 0
+61 8 82751103
Fax 231 0
+61 8 82751130
Email 231 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.