Outcome Measures for Lower Limb Amputees - A Rehabilitation Study

This study is currently recruiting participants.
Verified September 2013 by Queen Margaret University
Sponsor:
Information provided by (Responsible Party):
Judy Scopes, Queen Margaret University
ClinicalTrials.gov Identifier:
NCT01946321
First received: September 16, 2013
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Lower Limb Amputation
Other: Post-amputation functional rehabilitation (normal clinical practice)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhD Research Project: Clinimetric Properties of Outcome Measures of Physical Function Used With Lower Limb Amputees, Study 1

Resource links provided by NLM:


Further study details as provided by Queen Margaret University:

Primary Outcome Measures:
  • The changes in scores in all tests during early rehabilitation period. [ Time Frame: 2 weeks and 6 weeks ] [ Designated as safety issue: No ]

    The changes in scores in all Outcome Measures during Time Period 1 and Time Period 3 will be recorded. For each Outcome Measure during each time interval the effect size (ES)will be calculated, using the formula below. These will serve as a statistical description of the sensitivity to change or responsiveness of each Outcome Measure.

    ES = mean diff (SV1-SV2) / (SD SV1-SV2) A higher ES value indicates higher responsiveness.



Secondary Outcome Measures:
  • Mean scores and the score changes recorded in the two time periods under investigation, i.e. T1 and T3 will be compared within the different categories in the Activity Change Questionnaire. [ Time Frame: 2 weeks and 6 weeks ] [ Designated as safety issue: No ]
    The mean score difference between "equal" group and the "slightly better" group will result in the Minimal Clinically Detectable Change (MCDC) for improvement. The corresponding MCDC for worsening in the same time period will be determined by the mean score difference between the "equal" group and the "slightly worse" group.


Other Outcome Measures:
  • Establish the minimal detectable changes (MDC) for each of the Outcome Measures [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
    b. In a subset of participants, establish the minimal detectable changes (MDC) for the Physical Function OMs, through test-retest measurements.


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Post-amputation functional rehab
Patients will continue with their rehabilitation programme, as specified by their clinical team, following amputation. A series of functional outcome measures will be carried out at 3 or 4 time points during the first 3 months following delivery of their artificial limb.
Other: Post-amputation functional rehabilitation (normal clinical practice)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Single lower limb amputees, at either trans-tibial (below-knee) or trans-femoral (above-knee) level 18 years or older Taking delivery of their first prosthesis (artificial limb)

Exclusion Criteria:

Limb-fitting for transfer activities only Co-morbidities that may prevent the amputee undertaking any of the physical activities involved in the OMs, such as: severe heart disease, respiratory disease or arthritis Poor cognition, as identified by the patient's clinical team, which may prevent the patient from fully understanding the written questionnaires

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946321

Contacts
Contact: Judy Scopes, MPhil JScopes@qmu.ac.uk

Locations
United Kingdom
Astley Ainslie Hospital Recruiting
Edinburgh, United Kingdom, EH9 2HL
Principal Investigator: Judy Scopes, MPhil         
Sponsors and Collaborators
Queen Margaret University
Investigators
Study Director: Marietta van der Linden, MSc, PhD Queen Margaret University, Edinburgh, UK
Principal Investigator: Judy Scopes, MPhil Queen Margaret University, Edinburgh, UK
  More Information

No publications provided

Responsible Party: Judy Scopes, PhD Student, Queen Margaret University
ClinicalTrials.gov Identifier: NCT01946321     History of Changes
Other Study ID Numbers: QMU/JS0121
Study First Received: September 16, 2013
Last Updated: September 19, 2013
Health Authority: United Kingdom: National Health Service

ClinicalTrials.gov processed this record on April 22, 2014