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Outcome Measures for Lower Limb Amputees - A Repeatability Study

NCT01953939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-03-18

No results posted yet for this study

Summary

During any period of rehabilitation it is important to select meaningful tests that; measure what you want, are responsive to changes in the patient's condition and, easy to use in the clinical settings. With an amputee such tests may help make sure that rehabilitation programmes and the prosthesis (artificial leg) provided are tailored for the individual. New prosthetic technology is continually being developed and the active amputee now demands more from their artificial limbs. Making sure that they get the right rehabilitation programmes and the most appropriate prosthesis will help them perform to their best.

Twenty lower limb amputees who have had their artificial limb for at least one year will be recruited into this study. They will be asked to complete 2 walking tests and 4 questionnaires that measure different aspects of their condition from the comfort of the socket to their perceived ability to undertake everyday tasks. Each of the tests give a score or grade which represents the level of their ability, as judged by the test, at that given time point. The tests will be repeated on a second occasion between seven to ten days after the first.

By measuring the changes in the scores on these two occasions it is hoped that indices of reliability can be established for these particular tests that have been shown to be most widely used by Health Professional involved in the rehabilitation of amputees across the UK. It is also hoped that the minimal detectable change (MDC) can also be calculated for these tests. By understanding the MDC for a test then anyone using it will be able to know whether any changes in scores detected are real changes due to changes in the patient's abilities or just down to chance.

Conditions

  • Lower Limb Amputation

Interventions

OTHER

Prosthetic Limb Users

There will be a time period of 7-10 days between data collection visits in this test-retest study which is measuring reliability in the functional outcome measures regularly used in clinical practice.

Sponsors & Collaborators

  • Queen Margaret University

    lead OTHER

Principal Investigators

  • Marietta van der Linden, MSc, PhD · Queen Margaret University, Edinburgh, UK

  • Judy Scopes, MPhil · Queen Margaret University, Edinburgh, UK

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01953939 on ClinicalTrials.gov