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临床试验/NCT05038189
NCT05038189Unknown不适用

Comparison of Spine Posture, Trunk Position Sense and Gait Characteristics Among Different Sub-types of Axial Spondyloarthritis Patients and Healthy Controls

Necmettin Erbakan University2 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
75
试验地点
2
主要终点
Spine posture

研究概览

简要总结

Axial Spondyloarthritis (Ax-SpA) are chronic systemic inflammatory rheumatological diseases characterized by axial skeletal involvement and enthesitis. Sacroiliitis is the most prominent sign of the disease. The International Society for the Evaluation of Spondyloarthritis created a new classification for Ax-SpA in 2009. According to this classification, Ax-SpA; It is divided into two groups as ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

With the emergence of the term nr-axSpA, studies have begun to compare AS and nr-axSpA in terms of genetic, epidemiological and clinical features, treatment needs and response to treatment.However, more studies are needed to better understand the clinical features and symptoms of nr-axSpA patients.

The aim of this study was to determine the clinical features of patients with nr-axSpA and AS; To evaluate spine posture, trunk position sense and gait parameters, and also to compare these results with healthy individuals.

详细描述

There are no studies comparing spine posture, trunk position sense and gait parameters in patients with nr-axSpA and AS. It is important to determine the changes that occur in nr-axSpA patients in the early period. At the same time, taking the necessary precautions and following these patients with the rehabilitation process can ensure that the radiographic development is delayed or not at all in the future.

Hypotheses:

H1: Trunk position sense is different from each other in individuals with Nr-axSpA and AS.

H2: Spatio-temporal features of gait are different in individuals with Nr-axSpA and AS.

H3: Plantar pressure distribution is different in individuals with Nr-axSpA and AS.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For AS and nr-axSpA;
  • Diagnosed with AS and nr-axSpA by a rheumatologist according to ASAS criteria,
  • Diagnosed with AS and nr-axSpA at least two years ago,
  • Volunteer to participate in the study,
  • Individuals between the ages of 18-65 will be included in the study.
  • For Healthy volunteers;
  • Volunteer to participate in the study,
  • Individuals between the ages of 18-65 will be included in the study.

排除标准

  • For AS and nr-axSpA;
  • Having orthopedic problems in the lower extremity,
  • Locomotor disorders (fractures and prostheses) and / or osteoporosis,
  • Having a history of lower extremity and spine surgery,
  • Having neurological and cognitive problems,
  • Having vision and hearing problems,
  • Regular exercise,
  • Individuals with kyphosis above 50 degrees will be excluded from the study.
  • For Healthy volunteers;
  • Having any musculoskeletal, neurological and rheumatological diseases,
  • Having any condition (advanced respiratory or orthopedic problems, fracture, sprain or spine surgery) that will prevent the evaluation,
  • Regular exercise,
  • Individuals who do not agree to participate in the study will be excluded from the study.

结局指标

主要结局

Spine posture

时间窗: 6 months

Thoracic and lumbar curvature tests will be performed with a digital inclinometer (Acumar®, Dual Digital Inclinometer, Lafayette Instrument Company, IN, USA). For throcic curvature, the 7th cervical vertebra, the most prominent spinous process, and the sacrum will be used as reference points to palpate the spinal processes of T1-T2 and T12-L1, respectively. The feet of the inclinometers will be placed as simultaneously as possible over T1-T2 and T12-L1. The angle on the digital display of the inclinometer will be recorded as degree. The mean of three successful measurements will be used. For lumbar curvature, the sacrum and iliac crest will be used as reference points to palpate the spinal processes of T12-L1 and L5-S1, respectively. The feet of the inclinometers will be placed as simultaneously as possible over T12-L1 and L5-S1. The angle on the digital display of the inclinometer will be recorded in degrees.

Gait analyses

时间窗: 6 months

The spatiotemporal parameters of gait will be evaluated using the Diagnostic Support Baropodometer Footscan® 3D system. The spatial parameters of gait, step length (cm), step width (cm) and foot angle (degrees) and the temporal parameters of gait, speed (m/min), cadence (step/min) and stance time (sec) will be recorded. For evaluating of the plantar pressure distribution will be used the Diagnostic Support Baropodometer Footscan® 3D system, besides the dynamic evaluation and recording of the spatiotemporal parameters, the data on the total load on the forefoot, midfoot and hindfoot; the average pressure; and the distribution of load in the forefoot, midfoot and hindfoot will be also obtained.

Trunk position sense

时间窗: 6 months

Trunk position sense, as indicated by trunk reposition errors (TRE), will be assessed with a digital inclinometer (Acumar®,Dual Digital Inclinometer, Lafayette Instrument Company, IN, USA). The participants will be asked to stand upright in a comfortable position. The inferior angle of the scapula will first palpated as a bony landmark to find the spinousprocess of T4. After the placement of the inclinometer over the spinous process of T4, the participants will be asked to flex the trunk approximately 30° in the sagittal plane and hold this position for 3 s in eyes closed position. After returning to the neutral upright position, they will be asked to duplicate the previously attained position and held the position for 3 s for five times in a row. The absolute differences between the original position and the other five attempts will be recorded. The highest and lowest scores will be discarded and the mean of the tree remaining scores will be used to assess the trunk position sense.

次要结局

  • Lumbopelvic stabilization assessment(6 months)
  • Bath Ankylosing Spondylitis Disease Activity Index(6 months)
  • Disease-Related Functional Status(6 months)
  • Stabilometric test(6 months)
  • Bath Ankylosing Spondylitis Metrology Index(6 months)
  • Disease-Related Quality of Life(6 months)
  • Musculoskeletal Health Questionnaire(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YASEMİN AKKUBAK

Research Assistant

Necmettin Erbakan University

研究点 (2)

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