Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00163787
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : October 25, 2005
Austin Health
Information provided by:
Bayside Health

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.

Condition or disease Intervention/treatment
Amputation Behavioral: outcome measures and self report

Detailed Description:


All unilateral trans-tibial amputees with prosthesis at discharge, who are over 18 years of age, willing to participate and give informed consent. Subjects will be excluded if visually unable to perform tests, cognitively unable to follow testing procedures or being discharged into supported accommodation.

Identify scores for unilateral trans-tibial amputees for; FSST, TUGT and turn measure items: (1) steps, (2) time and (3) steadiness & fluency of movement.

Evaluate the validity, predictive value, sensitivity & specificity of the balance and mobility measures for falls and community ambulation with trans-tibial amputees.

Study Type : Observational
Enrollment : 50 participants
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Clinical Identification of Increased Fall Risk Early After Unilateral Transtibial Amputation
Study Start Date : June 2003
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • over 18 years unilateral transtibial amputee

Exclusion Criteria:

  • visually unable to perform tests cognitively unable to perform tests unable to provide informed consent not being discharged into supported accommodation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00163787

Australia, Victoria
Austin Health Royal Talbot Rehabilitation Centre
Melbourne, Victoria, Australia, 3101
Sponsors and Collaborators
Bayside Health
Austin Health
Principal Investigator: Wayne Mr Dite, MAppSci Austin Health Royal Talbot Rehabilitation Centre Identifier: NCT00163787     History of Changes
Other Study ID Numbers: 79/03
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: October 25, 2005
Last Verified: September 2005

Keywords provided by Bayside Health:
activity level