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临床试验/NCT05589922
NCT05589922已完成不适用

Determining the Relationship Between Abnormal Modified Schober Index and Demographic Characteristics and Clinical Variables in Patients With Ankylosing Spondylitis

Mustafa Kemal University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月24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
100
试验地点
1
主要终点
tandem stance test

研究概览

简要总结

This study will aim to compare ankylosing spondylitis (AS) participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. In addition, the investigators will aim to determine which demographic characteristics and variables predispose AMSI to occur

详细描述

Ankylosing spondylitis (AS), a common type of spondyloarthropathy, is a chronic inflammatory disease that affects spinal joints, and adjacent soft tissues such as sacroiliac joints, tendons, and entheses (1). Inflammation of the spinal structures and progressive changes in the surrounding tissue is largely responsible for decreased physical function and mobility in participants with AS (2).

It is unknown how these parameters of AS participants with AMSI (smaller than 5 cm) are affected compared to AS participants with normal modified Schober index (NMSI, bigger than 5 cm). In addition, it is unclear which demographic characteristics and variables predispose AMSI to occur.

This study will aim to compare AS participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. In addition, the investigators will aim to determine which demographic characteristics and variables predispose AMSI to occur

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Participants who meet the modified New York criteria for AS
  • Participants over 18 years

排除标准

  • Participants with other concomitant rheumatic diseases (such as fibromyalgia, rheumatoid arthritis, etc.),
  • Participants with cognitive or psychiatric disorders,
  • Participants with neuromuscular or orthopedic diseases

结局指标

主要结局

tandem stance test

时间窗: At baseline

For the tandem stance test, patients stand holding onto a railing while placing one foot in front of the other. The researcher standing behind the patient starts timing when the patient's contact with the railing is released. It is recorded for 30 seconds or until participants contact external support or move out of tandem stance

Timed up and go test

时间窗: at baseline

It aims to assess mobility and balance. It measures the time in seconds for a subject to stand up from an armchair, walk 3 m, turn, walk back to the chair, and sit down

Falls Efficacy Scale-International

时间窗: At baseline

The FES-I consists of 16 questions questioning how confident patients are in performing activities without falling. According to the answers, each question is scored between 1 and 4 (1 = not at all concerned, 4 = very concerned), and a higher score is associated with a greater fear of falling

Tampa Scale for Kinesiophobia

时间窗: At baseline

The TSK contains 17 questions which measures fear of movement and/or reinjury. The scale uses 4-point Likert scoring (1 = entirely disagree, 4 = entirely agree). A total score ranges from 11 to 44 points and a cut-off point was determined as ≥37 points indicate a high kinesiophobia level

Modified Schober Index

时间窗: at baseline

The measurement of the MSI starts with the subject in an upright posture. After being determined the posterior superior iliac spines, a horizontal line is drawn at the center of both posterior superior iliac spines. Ten cm above and five cm below the first line are marked. The distance between the top and bottom line is remeasured after the patient attempts to flex forward as far as possible while keeping the knees straight

Bath AS Metrology Index (BASMI)

时间窗: at baseline

The BASMI is evulated quantify the mobility of the axial skeleton and includes assessments of lateral lumbar flexion, tragus-to-wall distance, lumbar flexion, intermalleolar distance, and cervical rotation. Each measure is assigned a score of 0 to 2 with the higher score indicating greater impairment in mobility

次要结局

  • 30-second chair sit-to-stand test(At baseline)
  • functional reach test(At baseline)
  • finger-to-floor distance measure(At baseline)
  • single leg stance test(At baseline)
  • Visual Analogue Scale(At baseline)

研究者

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

Gamze Kus

assistant professor

Mustafa Kemal University

研究点 (1)

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