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Outcome Measures for Lower Limb Amputees - A Rehabilitation Study

NCT01946321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

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.

Thirty amputees who have recently undergone a lower limb amputation will be recruited into this study. They will be asked to complete 2 walking tests and 4 questionnaires that measure different aspects of their recovery 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 at one and three weeks after delivery of their prosthesis, just before discharge from hospital and at 6 weeks post-discharge.

By measuring the changes in the scores across these time points, and also how the amputees feel they have changed, it is hoped that it can be determined how responsive the tests are to objective measures of changes in the amputees abilities and also whether the tests are sensitive to the changes felt by the amputee. If it is shown we can more accurately link changes in the scores to the changes in the amputees abilities then Physiotherapy treatment programmes could be more accurately tailored to the individual amputee.

Conditions

  • Lower Limb Amputation

Interventions

OTHER

Post-amputation functional rehabilitation (normal 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
Purpose
TREATMENT
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 NCT01946321 on ClinicalTrials.gov