Outcome Measures for Lower Limb Amputees - A Repeatability Study

NCT01953939 | Completed

• 1 other identifier: QMU/JS0122
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Reliability of functional outcome measures

  The scores of all the Outcome Measures under investigation will be noted at Test Visit 1(TV1) and then on a second occasion, 7 to 10 days later, at Test Visit 2 (TV2). Test-retest reliability using the Intraclass Correlation Coefficient and Bland Altman limit of agreements will be calculated for each of the Outcome Measures.

  1 week

Secondary Outcomes (1)

• Minimal detectable change (MDC) of functional OMs

  1 week

Study Arms (1)

Prosthetic Limb Users

EXPERIMENTAL

Single lower limb amputees who are wearing their artificial limb all day and are using them outdoors for the majority of the time will be enrolled into this reliability study.

Other: Prosthetic Limb Users

Interventions

Prosthetic Limb Users OTHER

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.

Prosthetic Limb Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single lower limb amputee, at either trans-tibial or trans-femoral level
• Aged 18 years or older
• Using a prosthesis (artificial limb) for at least 1 year
• Wearing their artificial limb at least 8 hours per day
• Has the ability to walk over different surfaces outdoors, i.e. is an active-user outdoors

You may not qualify if:

• Any recent (within 3 months) changes of prosthetic components or physiotherapy treatment.
• Any co-morbidities that prevent the participant undertaking any of the physical activities involved in the OMs
• Poor cognition as identified by the patient's clinical team, which may prevent the patient from fully understanding the written questionnaires

Sponsors & Collaborators

• Queen Margaret University: lead

Study Sites (1)

Astley Ainslie Hospital

Edinburgh, EH9 2HL, United Kingdom

Location

Study Officials

• Marietta van der Linden, MSc, PhD

  Queen Margaret University, Edinburgh, UK

  STUDY DIRECTOR

• Judy Scopes, MPhil

  Queen Margaret University, Edinburgh, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: October 1, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

GB (1)