Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation

Amputation Clinical Trial

Official title:

Clinical Identification of Increased Fall Risk Early After Unilateral Transtibial Amputation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163787
• Other study ID #: 79/03
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 24, 2005
• Start date: June 2003
• Est. completion date: August 2005

Study information

• Verified date: September 2005
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Amputation

Intervention

Behavioral:
• outcome measures and self report

Locations

Country	Name	City	State
Australia	Austin Health Royal Talbot Rehabilitation Centre	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Bayside Health	Austin Health

Country where clinical trial is conducted

Australia,