Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation

This study has been completed.
Sponsor:
Collaborator:
Austin Health
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163787
First received: September 12, 2005
Last updated: October 24, 2005
Last verified: September 2005
  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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00163787     History of Changes
Other Study ID Numbers: 79/03
Study First Received: September 12, 2005
Last Updated: October 24, 2005
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
mobility
falls
activity level

ClinicalTrials.gov processed this record on July 22, 2014