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临床试验/NCT03776981
NCT03776981已完成不适用

The Effects of Core Activation and Stabilization Training on Gait Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients With Knee Osteoarthritis

Louisiana State University Health Sciences Center Shreveport1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Time to First Peak Ground Reaction Force in the Sagittal Plane (T1)

研究概览

简要总结

This will be the second investigation by the PI and sub-investigator on this topic, following the promising results of a pilot study on a small sample size (N=5) completed last year. Whether or not core stabilization influences gait impairments in patients with KOA remains to be seen. Core stabilization has been shown to have positive effects, including increased stride velocity and scores on functional tests like the Functional Reach Test and Timed Up and Go, in older adults. Older adults were also shown to have high compliance with a core stability training program. A systematic review indicated that core training is important to consider when treating older individuals to improve functional use of the extremities, improving participation in activities of daily living, and as part of a fall prevention program. Additionally, it has been shown to benefit young, active individuals in preventing anterior cruciate ligament injury and greater duration of improved outcomes in patients with patellofemoral pain syndrome. Athletes with decreased core control have been shown to be at an increased risk of knee injury as well. One potential cause for this is the ability of the core to improve lower extremity kinematics when activated during challenging single leg weight bearing activity. A recent publication by Azuma, et al. did indicate that paraspinal and anterior abdominal thinning had a negative predictive relationship to the presence of KOA; however, no investigation has explored a cause and effect relationship between core stability/stabilization training and the presence or severity of KOA, nor the gait and functional ability of patients with KOA. This later concept is the focus of this investigation.

详细描述

Unpublished pilot data collected by the same PI and sub-investigator shows that volitional activation of the TA during self-selected paced ambulation significantly decreases the time to first peak ground reaction force (T1) in the sagittal plane in participants with KOA (D.W. Flowers, C. Frilot, unpublished data, May 2018). This same kinetic gait variable is included in this investigation as one of the dependent variables in all three parts of the investigation.

Nearly four percent of the global population has KOA, with the global female percentage nearing five percent. Additionally, the years lived with disability (YLDs) resulting from the disorder increased by 64.8% from 1990 to 2010. The picture is not much better in the United States, where osteoarthritis ranks eighth highest in YLDs compared to other pathologies. The rate of KOA has continued to climb here in the U.S., doubling in the past half-century even when accounting for increased life expectancy and higher average BMI, both of which are considered risk factors in the development of KOA.

Patients with KOA have been shown to have gait abnormalities when compared to healthy controls, including alterations in trunk and pelvic kinematics, lower extremity kinematics and kinetics, gait speed, and functional outcome measure scores. Some of these differences, like an increased external knee adduction moment (KAM) and a decreased peak stance knee flexion angle (KFA), have been shown to correlate with the advancement of KOA and may be causative in nature. Others, like an increased T1 and reduced freely chosen gait speed, may be compensatory. The same has been found in regard to the reduced second peak ground reaction force in the sagittal plane (F2) observed in this population.

Reduced gait speed alone is predictive of increased fall risk in older adults, without any need to consider additional activities performed during walking tasks. Additionally, the gait impairments observed in this population can be so extreme that they can be more limiting than those observed in patients with diagnoses typically considered more severe, like congestive heart failure, diabetes, heart disease, and stroke. Therefore, improving function via improving gait speed via novel approaches is indicated, but not at the expense of increasing wear and tear on osteoarthritic joints. This investigation aims to show that core stabilization, which has been shown beneficially influence the kinetics and kinematics of lower extremity movements in younger, more active populations, can serve the same purpose in a population with KOA. The investigators are specifically trying to improve self-perceived function and gait speed, via improving the kinetics and kinematics observed in self-selected ambulation.

This investigation will be divided into three parts, each associated with one of the specific aims detailed in Section 1. All procedures will be performed in the School of Allied Health Professions, either in the Motion Analysis Laboratory (Gait Lab) or the Rehabilitation Faculty Practice (RFP) Clinic.

研究设计

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

入排标准

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

入选标准

  • •English-speaking men and women
  • •40 years old and older
  • •any race or ethnic group
  • •a documented diagnosis from a medical provider (i.e., physician, physician assistant, or nurse practitioner, etc.) of KOA, unilaterally or bilaterally.
  • •Previous or current physical therapy patients may be included (see

排除标准

  • •for exceptions).
  • •Healthy controls will meet the same requirements, but:
  • •without a medical diagnosis of KOA
  • •have the ability to ambulate on a level surface without any report of pain in their knees at the time of gait assessment.
  • •Exclusion Criteria:
  • •Those with other lower extremity injuries (orthopaedic, cardiovascular, neurologic, etc.) which are currently hindering their ability to ambulate
  • •those with current complaints of low back pain
  • •those who have undergone bilateral total knee arthroplasty
  • •those with concomitant diagnosis of rheumatoid arthritis
  • •those persons not able to ambulate independently with or without an assistive device
  • •those who have received a corticosteroid injection within the past two months
  • •those who have received a hyaluronic acid injection in the past six months
  • •those persons currently enrolled in a core training program as part of formal physical therapy or physical fitness.

研究组 & 干预措施

Baseline Gait Comparisons of Groups

No Intervention

Determine if kinetic (time to first peak ground reaction force [T1] and second peak ground reaction force [F2], both in the sagittal plane) and kinematic (peak stance knee flexion angle [KFA] and external knee adduction moment [KAM]) gait variables, and speed, differ between patients with KOA and age and gender matched controls during self-selected paced ambulation, and determine which ones have predictive relationships with Knee Injury and Osteoarthritis Outcome Score (KOOS) scores in the patients with KOA.

Gait with core activation

Experimental

Determine if volitional core activation alters gait kinetics (T1 and F2), kinematics (KFA and KAM), and speed in patients with and without KOA during self-selected paced ambulation when compared to ambulating without volitional core activation, and whether the subjective pain complaints are significantly changed in the group with KOA. Determine whether there are baseline differences in core activation between those with and without KOA.

干预措施: Core Activation (Other)

Knee OA Gait After core stabilization

Experimental

Determine if a six-week core stabilization program alters KOOS score, and the kinetics (T1 and F2), kinematics (KFA and KAM), and speed of gait in patients with KOA during self-selected paced ambulation as compared to their pre-intervention baselines. Determine if there is a predictive relationship between the number of completed intervention sessions performed and these observed changes.

干预措施: Core Stabilization (Other)

结局指标

主要结局

Time to First Peak Ground Reaction Force in the Sagittal Plane (T1)

时间窗: Through study completion, on average about 1 year.

Kinetic variable observed during gait analysis.

Second Peak Ground Reaction Force in the Sagittal Plane (F2)

时间窗: Through study completion, on average about 1 year.

Kinetic variable observed during gait analysis.

Peak Stance Knee Flexion Angle (KFA)

时间窗: Through study completion, on average about 1 year.

Kinematic variable observed during gait analysis.

External Knee Adduction Moment (KAM)

时间窗: Through study completion, on average about 1 year.

Kinematic variable observed during gait analysis.

Gait Speed

时间窗: Through study completion, on average about 1 year.

Self-selected gait velocity of each participant during gait analysis.

次要结局

  • Pain Rating on Visual Analog Scale (VAS)(Through study completion, on average about 1 year.)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS)(Through study completion, on average about 1 year.)
  • Transversus Abdominis Activation(Through study completion, on average about 1 year.)

研究者

发起方
Louisiana State University Health Sciences Center Shreveport
申办方类型
Other
责任方
Sponsor

研究点 (1)

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