Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04619550 |
| Other study ID # |
BLS/19/07 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2019 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
November 2020 |
| Source |
University of Winchester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to investigate the relationship between pain, gait and activity intensity in
HTO patients that are healed and have had their fixation plate removed.
Inclusion criteria are: unilateral HTO with no concurrent procedure performed, fixation plate
has since been removed, no subsequent operations performed on the lower limbs (hips to feet).
Control participants will be recruited through local advertisements in and around the
University of Winchester. Inclusion criteria for the control subjects are: no current pain in
the lower limbs, no previous surgery on the lower limbs. Control subjects will also be
age-matched to the HTO group.
Knee function and pain scores will first be assessed through the implementation of a Knee
Osteoarthritis Outcome Score, a Visual Analogue Scale, and a further pain intensity scale.
Once this has been done, resting heart rate (HR) and body mass index (BMI) will also be
measured as part of the completion of a Physical Activity Readiness Questionnaire (PAR-Q). A
G-Walk gait analysis sensor, which has been validated for use in clinical settings, will then
be attached to participants in order to measure spatiotemporal gait parameters during
testing.
Each participant will then conduct a series of four walking and four jogging test protocols,
each lasting three minutes, on a flat treadmill. The intensity at which the participant must
walk or jog during each test will be self-regulated and determined by a rating of perceived
exertion (RPE) of 9, 11, 13 or 15 on a 6-20 Borg scale. All participants will be verbally
anchored to the Borg scale before conducting the first walk/jog test. The order in which the
tests are performed will be randomised in advance of each test session. Half way through each
test (90 seconds), participants will be presented with a VAS and pain intensity scale to
indicate the current level of pain they are experiencing in their knee. At this stage, they
will also be asked to confirm that they are still maintaining the target RPE of that
particular test. Once a test is finished, participants will complete another VAS and pain
intensity scale and rest in a seated position until their heart rate returns to their
pre-determined resting level before the next test commences. The leg for which healthy
controls report pain levels will be chosen randomly prior to the test session.
Description:
This study aims to investigate the relationship between pain, gait and activity intensity in
HTO patients that are healed and have had their fixation plate removed.
Inclusion criteria are: unilateral HTO with no concurrent procedure performed, fixation plate
has since been removed, no subsequent operations performed on the lower limbs (hips to feet).
Control participants will be recruited through local advertisements in and around the
University of Winchester. Inclusion criteria for the control subjects are: no current pain in
the lower limbs, no previous surgery on the lower limbs. Control subjects will also be
age-matched to the HTO group.
Knee function and pain scores will first be assessed through the implementation of a Knee
Osteoarthritis Outcome Score, a Visual Analogue Scale, and a further pain intensity scale.
Once this has been done, resting heart rate (HR) and body mass index (BMI) will also be
measured as part of the completion of a Physical Activity Readiness Questionnaire (PAR-Q). A
G-Walk gait analysis sensor, which has been validated for use in clinical settings, will then
be attached to participants in order to measure spatiotemporal gait parameters during
testing.
Each participant will then conduct a series of four walking and four jogging test protocols,
each lasting three minutes, on a flat treadmill. The intensity at which the participant must
walk or jog during each test will be self-regulated and determined by a rating of perceived
exertion (RPE) of 9, 11, 13 or 15 on a 6-20 Borg scale. All participants will be verbally
anchored to the Borg scale before conducting the first walk/jog test. The order in which the
tests are performed will be randomised in advance of each test session. Half way through each
test (90 seconds), participants will be presented with a VAS and pain intensity scale to
indicate the current level of pain they are experiencing in their knee. At this stage, they
will also be asked to confirm that they are still maintaining the target RPE of that
particular test. Once a test is finished, participants will complete another VAS and pain
intensity scale and rest in a seated position until their heart rate returns to their
pre-determined resting level before the next test commences. The leg for which healthy
controls report pain levels will be chosen randomly prior to the test session.
