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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00163787




Registration number
NCT00163787
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
25/10/2005

Titles & IDs
Public title
Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation
Scientific title
Clinical Identification of Increased Fall Risk Early After Unilateral Transtibial Amputation
Secondary ID [1] 0 0
79/03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amputation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Behaviour - outcome measures and self report

Behaviour: outcome measures and self report
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- over 18 years unilateral transtibial amputee
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- visually unable to perform tests cognitively unable to perform tests unable to provide
informed consent not being discharged into supported accommodation

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health Royal Talbot Rehabilitation Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3101 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austin Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
All participants attend for two testing sessions at either Royal Talbot Rehabilitation Centre
or the centre where they received inpatient physiotherapy services.

All participants will be tested at discharge and at six months post discharge. Personnel used
to score and administer the balance tests at six months will be blinded to pre-test scores,
subject background, as well as, mobility and fall history in the six months post discharge.

At discharge participants will perform two successful Four Square Step Tests (FSST, and will
be videotaped performing the Timed Up and Go Test (TUGT. The turn measure will be scored from
this TUGT. Participants will also complete the Locomotor Capabilities index (LCI).

At the six-month test participants repeat balance and mobility tests and LCI, as well as
being interviewed to ascertain fall history since discharge.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00163787
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Wayne Mr Dite, MAppSci
Address 0 0
Austin Health Royal Talbot Rehabilitation Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00163787