- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00163787
Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation
Clinical Identification of Increased Fall Risk Early After Unilateral Transtibial Amputation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3101
- Austin Health Royal Talbot Rehabilitation Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wayne Mr Dite, MAppSci, Austin Health Royal Talbot Rehabilitation Centre
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 79/03
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