Lower Limb Amputation Clinical Trial
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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