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临床试验/NCT06297694
NCT06297694已完成不适用

Clinical Interpretation and Cutoff Scores for Manual Ability Measured by the ABILHAND Questionnaire in Individuals With Rheumatoid Arthritis

Pamukkale University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年4月1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
156
试验地点
1
主要终点
Nine hole peg test

研究概览

简要总结

In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis.

研究设计

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

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People between the ages of 20-65, who were diagnosed with RA according to ACR criteria by the PAU Rheumatology clinic and who volunteered to participate in the study, will be included.

排除标准

  • Patients with RA who have a neurological disease that may affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident), a psychiatric disease that affects cooperation, heart failure and lung pathology that affect daily living activities, and those with other concurrent autoimmune and rheumatic diseases.

结局指标

主要结局

Nine hole peg test

时间窗: Baseline

It is a battery that aims to measure the loss of skills in the hand. This device is a device consisting of a square platform and a storage box. There are 9 holes in the square area (12.7x2cm) and 9 cylinders suitable for these holes. The diameter of the holes was 0.71 cm, the diameter of the cylinders was 0.64 cm, the length was 3.2 cm, the distance between the holes was 3.2 cm, the hole depth was 1.3 cm and the size of the storage box was 13x13 cm. What is requested from the patients is to quickly take the 9 cylinders from the storage box, place them in the holes, quickly remove them from the holes and place them in the storage box, without taking a break. Meanwhile, the time is measured in seconds with a stopwatch. Three separate measurements will be made for the right and left hand and the average will be taken.

Hand grip strength

时间窗: Baseline

Grip strength in the dominant and non-dominant hand will be evaluated in 'kg' unit with a JAMAR (Sammons Preston, USA) hand dynamometer. Patients will be measured in a sitting position with the elbow flexed at 90° and the wrist in the mid-position with the thumb pointing up. The measurement will be made three times consecutively and the average value will be used. Values will be recorded in kilogram units.

Disease Activity Score (DAS 28)

时间窗: Baseline

It is used to evaluate disease activity in individuals with rheumatoid arthritis. DAS28 is a tool consisting of 28 tender joint count (range 0-28), 28 swollen joint count (range 0-28), ESR (erythrocyte sedimentation rate) and overall health assessment on a visual analogue scale (range 0-100). The level of disease activity is low It is interpreted as (DAS28 ≤3.2), medium (3.2\< DAS28 ≤ 5.1) or high (DAS28 \> 5.1).

次要结局

未报告次要终点

研究者

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

Berna Cagla Balkisli

Principal Investigator

Pamukkale University

研究点 (1)

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