Outcome Measures for Lower Limb Amputees - A Rehabilitation Study

March 17, 2016 updated by: Judy Scopes, Queen Margaret University

PhD Research Project: Clinimetric Properties of Outcome Measures of Physical Function Used With Lower Limb Amputees, Study 1

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Outcome Measures (tests) to be used in this study were identified from a survey of Health Professionals across the UK. The top 5 in use were:

SIGAM Mobility Grades The Special Interest Group in Amputee Medicine (SIGAM) Mobility Grades describe a single-item scale comprising of six clinical grades (A -F) of amputee mobility. A self-reported questionnaire has 21 yes/no items and when the answers are applied to an algorithm a final clinical grade is assigned.

Timed up and go (TUAG) The TUAG test is a standardised quantitative measure of most of the manoeuvres required for 'basic mobility'. The subject is timed as they stand up from a chair, walk 3m, turn and return to the chair. The score is simply the time taken to complete the circuit.

Timed Walk Test A walk test is often used to measure functional exercise capacity. Participants are instructed to walk from end to end of an enclosed quiet corridor, covering as much ground as possible in the allotted time period. The primary outcome of interest is distance walked, but velocity can also be calculated.

Locomotor Capability Index, basic (LCI) and advanced (LCI-5) The Locomotor Capability Index (LCI) is a self-administered scale specifically designed for use with lower limb amputees. It has 14 questions about locomotor activities. The answers required are either yes or no to questions phrased such as: "Would you say you are able to do the following activities with your prosthesis on?" The LCI can be sub-divided into 2 subscales: basic and advanced. The total scores from each activity are totaled for a possible maximum score of 42 (basic) and 56 (advanced).

Socket Comfort Score This score is a simple subjective measure of how comfortable the amputee feels the socket is at the time the score is taken. Amputees are asked a standard question: 'On a 0 - 10 scale, if 0 represents the most uncomfortable socket fit you can imagine, and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?" Their response on the 11 point scale is then recorded.

Finally the EQ-5D™ will be administered at each study visit. The EQ-5D™ is a self-administered, standardised instrument that measures health outcomes. It provides a simple descriptive profile and a single index for health status.

In addition an Activity Change Questionnaire will be given to the participants which will gather information from the participants about how they feel their ability to perform everyday tasks has changed, if at all, from a previous time. They will be asked to use the assessment categories "much worse", "slightly worse", "equal", "slightly better" and "much better".

At the first Study Visit (SV1) written consent will be obtained from the amputee by the Researcher and the amputee will be enrolled as a study participant. Baseline measurements for all the tests will also be taken at this visit as well as basic demographic data recording age, cause of amputation, level of amputation and any relevant concomitant medical history.

Study Visit 2 (SV2) will occur 2 weeks following SV1 and the tests will be repeated. A change questionnaire will also be given to the participant which will record on a 5 point Likert scale how they feel their ability to perform everyday tasks has changed compared to SV1. A second set of tests scores will be collected on a sub-set of participants at this time point approximately 24 hours after the first scores to investigate the reliability of the measures in this acute rehabilitation period.

Study Visit 3 (SV3) will occur during the week before the participant is discharged from hospital. Discharges from hospital are planned in advance and therefore it is anticipated that this visit is likely to be 3-5 days prior to the actual discharge from hospital. The same tests will be repeated at this visit. However, if discharge occurs within 1 week of SV2 then the tests will not be repeated and the scores obtained at SV2 will be used in any calculations.

The last Study Visit (SV4) will occur 6 weeks following discharge from hospital, to coincide with the participants 6 week post-discharge multi-disciplinary team clinic appointment at the Southeast Mobility and Rehabilitation Technology (SMART) Centre adjacent to the Physiotherapy Department at Astley Ainslie Hospital. The tests will be repeated at this visit. A change questionnaire will also be given to record how the participant feels their ability to perform everyday tasks has changed compared to SV3. A further question will be added to ask how they feel their ability to perform everyday tasks has changed compared to SV1.

Every effort will be made to complete the tests at the same time of day for each of the participant's study visits and the order of the measurements will be randomly assigned at each visit.

The changes in scores in all tests will be recorded during three time periods. Time period 1 (T1), between SV1 and SV2, represents the very early stages of prosthetic limb rehabilitation.

Time period 2 (T2), between SV1 and SV3 (or SV2 if SV3 not done), represents the period of in-patient rehabilitation. The limitation of T2 is that the length of stay is variable for each patient and will therefore not be used in the primary outcome analysis.

Time period 3 (T3), between SV3 (or SV2 if SV3 not done) and SV4, represents time period immediately following discharge.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH9 2HL
        • Astley Ainslie Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The changes in scores in all tests during early rehabilitation period.
Time Frame: 2 weeks and 6 weeks

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.
2 weeks and 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
2 weeks and 6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Establish the minimal detectable changes (MDC) for each of the Outcome Measures
Time Frame: 24hrs
b. In a subset of participants, establish the minimal detectable changes (MDC) for the Physical Function OMs, through test-retest measurements.
24hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen Margaret University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Marietta van der Linden, MSc, PhD, Queen Margaret University, Edinburgh, UK
  • Principal Investigator: Judy Scopes, MPhil, Queen Margaret University, Edinburgh, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QMU/JS0121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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