Lower Limb AmputationNCT01953939
Outcome Measures for Lower Limb Amputees - A Repeatability Study
A study testing Prosthetic Limb Users in people with Lower Limb Amputation, run by Queen Margaret University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Prosthetic Limb Users
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PhD Research Project: Clinimetric Properties of Outcome Measures of Physical Function Used With Lower Limb Amputees, Study 2
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.
Read the 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 of amputee mobility. A self-reported questionnaire has 21 yes/no items and when the answers are applied to an algorithm a final grade is assigned. There are 8 grades that can be 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 the time, in seconds, taken to complete the circuit.
2 Minute Walk Test A timed 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 two minutes. The score will be the distance walked in metres.
Locomotor Capability Index LCI-5) The Locomotor Capability Index (LCI-5) 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 total scores from each activity are totalled for a possible maximum score of 56.
Socket Comfort Score This score is a 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. The EQ-5D™ is a self-administered, standardised instrument that measures health outcomes. It provides a simple descriptive profile and a single index for the participants health status at the time of the test.
At the first Test Visit (TV1) 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.
This study utilises a test-retest methodology and Test Visit 2 (TV2) will occur within 7 and 10 days of TV1 when the tests will be repeated.
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.
- Conditions
- Lower Limb Amputation
- Being tested
- Prosthetic Limb Users
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic Limb UsersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prosthetic Limb Users |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
Minimal detectable change (MDC) of functional OMs
The individual differences in the scores of each of the Outcome Measures between Test Visit 1(TV1) and a second occasion 7 to 10 days later , at Test Visit 2 (TV2) will be calculated. The standard error of measurement (SEM) will then be used to calculate the minimal detectable change (MDC), with a 90% confidence interval, for each of the Outcome Measures.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judy Scopes, Queen Margaret University
- Investigators
- Marietta van der Linden, MSc, PhD, Study director, Queen Margaret University, Edinburgh, UKJudy Scopes, MPhil, Principal investigator, Queen Margaret University, Edinburgh, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953939
- Sponsor's protocol ID
- QMU/JS0122
- Status last verified
- Mar 2016
- First submitted
- 16 Sep 2013
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhD Research Project: Clinimetric Properties of Outcome Measures of Physical Function Used With Lower Limb Amputees, Study 2
- ClinicalTrials.gov ID
- NCT01953939
- Acronym / sponsor ID
- QMU/JS0122
- Conditions
- Lower Limb Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 of amputee mobility. A self-reported questionnaire has 21 yes/no items and when the answers are applied to an algorithm a final grade is assigned. There are 8 grades that can be 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 the time, in seconds, taken to complete the circuit.
2 Minute Walk Test A timed 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 two minutes. The score will be the distance walked in metres.
Locomotor Capability Index LCI-5) The Locomotor Capability Index (LCI-5) 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 total scores from each activity are totalled for a possible maximum score of 56.
Socket Comfort Score This score is a 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. The EQ-5D™ is a self-administered, standardised instrument that measures health outcomes. It provides a simple descriptive profile and a single index for the participants health status at the time of the test.
At the first Test Visit (TV1) 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.
This study utilises a test-retest methodology and Test Visit 2 (TV2) will occur within 7 and 10 days of TV1 when the tests will be repeated.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthetic Limb Users | Experimental | Other: Prosthetic Limb UsersSingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthetic Limb UsersThere 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. | Other | Prosthetic Limb Users |
Primary outcome
Reliability of functional outcome measures
Time frame: 1 week
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 secondary outcome
Minimal detectable change (MDC) of functional OMs
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marietta van der Linden, MSc, PhD study director
Queen Margaret University, Edinburgh, UK
Judy Scopes, MPhil principal investigator
Queen Margaret University, Edinburgh, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic Limb Users in people with Lower Limb Amputation, run by Queen Margaret University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of functional outcome measures (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.