Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation

NCT ID: NCT00163787

Last Updated: 2005-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amputation

Keywords

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mobility falls activity level

Study Design

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Observational Model Type

NATURAL_HISTORY

Study Time Perspective

OTHER

Interventions

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outcome measures and self report

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austin Health

OTHER_GOV

Sponsor Role collaborator

Bayside Health

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Wayne Mr Dite, MAppSci

Role: PRINCIPAL_INVESTIGATOR

Austin Health Royal Talbot Rehabilitation Centre

Locations

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Austin Health Royal Talbot Rehabilitation Centre

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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79/03

Identifier Type: -

Identifier Source: org_study_id