Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation
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|ClinicalTrials.gov Identifier: NCT00163787|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : October 25, 2005
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|
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|
|Official Title:||Clinical Identification of Increased Fall Risk Early After Unilateral Transtibial Amputation|
|Study Start Date :||June 2003|
|Study Completion Date :||August 2005|
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
|Austin Health Royal Talbot Rehabilitation Centre|
|Melbourne, Victoria, Australia, 3101|
|Principal Investigator:||Wayne Mr Dite, MAppSci||Austin Health Royal Talbot Rehabilitation Centre|