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临床试验/NCT03218267
NCT03218267已完成不适用

Does the Total Hip Replacement Impact of Postural Stability?

Poznan University of Medical Sciences0 个研究点目标入组 60 人开始时间: 2014年9月1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
60
主要终点
Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects.

研究概览

简要总结

Total hip replacement (THR) is the procedure which can improve the quality of life in patients with osteoarthritis. However, deficits in static stability and impairment of the lower limb efficiency can be observed even several months after procedure. The aim of this study was to investigate the static balance of the standing position in patients treated by THR.

详细描述

The balance platform and one leg standing test (OLS) were used to assess the static balance. The postural balance tests were performed on the Metitur Good Balance platform. Static balance tests on balance platform were performed in several position with different foot placement like: normal standing with eyes open (NS EO) and eyes closed (NS EC) position, tandem position (TP), second form of tandem position (2TP) and one leg standing position (1L). Participants were asked to maintain the motionless upright position with both arms at their sides and eyes staring at a target in front of them.

During the normal standing (NS) position the patient stood on the platform barefoot with the feet placed parallelly (symmetric position of feet) with a 20 cm distance between them. The length of the trials with EO and EC was 30 seconds each.

In TP (tandem position) the width of base of support was narrowed down significantly, therefore test lasted only 10 s. During the test in TP one foot was placed directly in the front of the other (on the line) and the heel of the front foot was touched the toes of the rear foot. Tests were performed tests in TP with the left foot in front (TLF) and with right foot in front (TRF) separately. In THR group the placement of the operated limb in the front stance was called the TOF test, while the placement of the non operated limb in the front stance was called the TNF test. The results obtained in TOF position and TNF position were compared with tandem control index (TC - mean of results obtained from control group in TLF and TRF positions).

In 2TP alternately left or right foot was places in front of the other, but the feet were placed on both sides of the line dividing platform to two parts (line was tangent to the medial edge of feet). The length of exercise was 20 s. Analogically to the tandem test, patients were examined with the operated (2TOF) and non operated limb (2 TNF) in the front. Results were compared to the second tandem control index (2TC) representing the mean results of the control group as was described above.

When testing one leg standing position on the balance platform, the patients were asked to raise one foot half the level of the calf of the supporting leg but not touching the stance limb. The trial lasted for 5 s. The test was stopped when the subject used his arms (touched the handrail) or used the raised foot (touched the floor). Usually after 2 failed attempts or fear of falling down procedure was stopped and results was not recording. The results of the patients after THR when standing on the operated (1 O) and non operated (1 N) leg were compared to the index denoting the mean results of the control group (1 C).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
59 Years 至 83 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for patients: total hip replacement the minimum of 6 months period since the procedure, age above 55 years, unassisted gait, and the minimum of 9 points on the AMTS scale
  • for healthy volunteers: without total hip replacement age above 55 years, unassisted gait, and the minimum of 9 points on the AMTS scale

排除标准

  • for patients: neurological diseases, muscles diseases, rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) and sciatica. Additionally we excluded patients who had operations in the area of the spine and lower limbs (knee arthroscopy with ACL reconstruction or meniscectomy, total knee replacement, total hip replacement in both extremities, osteotomy or arthrodesis).
  • for healthy volunteers: neurological diseases, muscles diseases, rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) and sciatica. Additionally we excluded patients who had operations in the area of the spine and lower limbs (knee arthroscopy with ACL reconstruction or meniscectomy, total knee replacement, total hip replacement in both extremities, osteotomy or arthrodesis).

研究组 & 干预措施

Individuals after total hip replacement

Experimental

Individuals after total hip replacement. Patients treated at the Out-Patient Ward of W. Dega Orthopaedic-Rehabilitation Clinical Hospital of Karol Marcinkowski University of Medical Sciences in Poznań. The examination of participants included the static posturography and one-leg standing test.

干预措施: Static Posturography (Other)

Individuals after total hip replacement

Experimental

Individuals after total hip replacement. Patients treated at the Out-Patient Ward of W. Dega Orthopaedic-Rehabilitation Clinical Hospital of Karol Marcinkowski University of Medical Sciences in Poznań. The examination of participants included the static posturography and one-leg standing test.

干预措施: One-leg standing test (OLS) (Other)

control group

Active Comparator

The group with healthy individuals; without total hip replacement. The examination of participants included the static posturography and one-leg standing test.

干预措施: Static Posturography (Other)

control group

Active Comparator

The group with healthy individuals; without total hip replacement. The examination of participants included the static posturography and one-leg standing test.

干预措施: One-leg standing test (OLS) (Other)

结局指标

主要结局

Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects.

时间窗: 6 months

Mean COP velocity \[mm/s\] and the value of the middle of spectrum \[Hz; mm\] is recorded in anteroposterior (AP) and mediolateral (ML) directions within posturographic evaluation in examination of every participant Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects. Mean COP velocity \[mm/s\] and the value of the middle of spectrum \[Hz; mm\] is recorded in anteroposterior (AP) and mediolateral (ML) directions within posturographic evaluation in examination of every participant

次要结局

  • Evaluation of the time of maintain one-leg standing position by the patients.(6 months)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Małgorzata Eliks

Assistant, MSc

Poznan University of Medical Sciences

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