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Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163787
First Posted: September 14, 2005
Last Update Posted: December 9, 2005
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.
Collaborator:
Austin Health
Information provided by:
Bayside Health
  Purpose

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 Intervention
Amputation Behavioral: outcome measures and self report

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Clinical Identification of Increased Fall Risk Early After Unilateral Transtibial Amputation

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Estimated Enrollment: 50
Study Start Date: June 2003
Estimated Study Completion Date: August 2005
Detailed Description:

Subjects:

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.

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00163787


Locations
Australia, Victoria
Austin Health Royal Talbot Rehabilitation Centre
Melbourne, Victoria, Australia, 3101
Sponsors and Collaborators
Bayside Health
Austin Health
Investigators
Principal Investigator: Wayne Mr Dite, MAppSci Austin Health Royal Talbot Rehabilitation Centre
  More Information

ClinicalTrials.gov Identifier: NCT00163787     History of Changes
Other Study ID Numbers: 79/03
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Bayside Health:
mobility
falls
activity level