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临床试验/NCT04619550
NCT04619550已完成不适用

Gait and Residual Pain at Different Physical Activity Intensities in High Tibial Osteotomy Patients and Healthy Controls

University of Winchester2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Spatiotemporal parameters of gait

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Experimental group:
  • Previously undergone unilateral medial opening wedge high tibial osteotomy with no simultaneous procedures (other than arthroscopy), performed by one of 3 different surgeons
  • Plate since removed
  • No conversion to arthroplasty since the osteotomy
  • Control group:
  • Age-matched to experimental group
  • Never previously undergone any form of lower limb surgery

排除标准

  • Experimental group:
  • Undergone other procedures simultaneous to the osteotomy
  • Plate in-situ
  • Control group:
  • Previously undergone lower limb surgery

结局指标

主要结局

Spatiotemporal parameters of gait

时间窗: 9 months recruitment - 2 hours data collection per participant

Steps, cadence, speed (etc) measured using G-Walk wireless inertial sensor

Self-reported pain questionnaire

时间窗: 9 months recruitment - 2 hours data collection per participant

Visual analogues scale (0-10, where 0 = no pain and 10 = the worst imaginable pain)

次要结局

  • Self-reported knee function questionnaire(9 months recruitment - 2 hours data collection per participant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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