Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04619550
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2020-10-16
Brief Title:
Gait Pain and Physical Activity After HTO
Sponsor:
University of Winchester
Organization:
University of Winchester
Study Overview
Official Title:
Gait and Residual Pain at Different Physical Activity Intensities in High Tibial Osteotomy Patients and Healthy Controls
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 walkjog 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
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 walkjog 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
Detailed 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 walkjog 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
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 walkjog 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None