Lower Limb AmputationNCT01946321
Outcome Measures for Lower Limb Amputees - A Rehabilitation Study
A study testing Post-amputation functional rehabilitation (normal clinical practice) 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?
- Post-amputation functional rehabilitation (normal clinical practice)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 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 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)
Who cannot join
- 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
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 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.
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 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.
- Conditions
- Lower Limb Amputation
- Being tested
- Post-amputation functional rehabilitation (normal clinical practice)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-amputation functional rehabilitation (normal clinical practice)Other
| Study group | Role | What they receive |
|---|---|---|
| Post-amputation functional rehab | Other | 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. Receives: Other: Post-amputation functional rehabilitation (normal clinical practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in scores in all tests during early rehabilitation period.
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.
Measured: 2 weeks and 6 weeks
Secondary outcomes (1)
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.
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.
Measured: 2 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01946321
- Sponsor's protocol ID
- QMU/JS0121
- 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 1
- ClinicalTrials.gov ID
- NCT01946321
- Acronym / sponsor ID
- QMU/JS0121
- Conditions
- Lower Limb Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 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
- 19 Sep 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-amputation functional rehab | Other | Other: Post-amputation functional rehabilitation (normal clinical practice)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Post-amputation functional rehabilitation (normal clinical practice) | Other | Post-amputation functional rehab |
Primary outcome
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.
1 secondary outcome
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
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 Post-amputation functional rehabilitation (normal clinical practice) 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 1 inclusion and 1 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?
The changes in scores in all tests during early rehabilitation period. (time frame: 2 weeks and 6 weeks). 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.