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临床试验/NCT06658470
NCT06658470Enrolling By Invitation不适用

Investigation of the Turkish Validity and Reliability of Hand Disability In Systemic Sclerosis - Digital Ulcersthe (HDISS-DU) Questionnaire in Individuals With Systemic Sclerosis

Pamukkale University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
72
试验地点
2
主要终点
The Hand Disability in Systemic Sclerosis-Digital Ulcers Questionnaire

研究概览

简要总结

The aim of this study was to examine the Turkish validity and reliability of the Hand Disability in Systemic Sclerosis - Digital Ulcers Questionnaire (HDISS-DU) in individuals with Systemic Sclerosis.

研究设计

研究类型
Observational
观察模型
Other
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

  • Diagnosed with SSc by a rheumatologist
  • Being 18 years of age or older

排除标准

  • Presence of neurological disease
  • Presence of any orthopedic problem that would affect functionality
  • Presence of a history of orthopedic surgery
  • Inability to speak or understand Turkish fluently
  • Presence of a psychiatric disease that would affect cooperation
  • Severe neurological disease that would affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident)
  • Heart failure and lung pathology that would affect daily living activities

结局指标

主要结局

The Hand Disability in Systemic Sclerosis-Digital Ulcers Questionnaire

时间窗: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

It was developed to evaluate the disability caused by digital ulcers in the hand in patients with Systemic Sclerosis. It consists of 24 questions. There are 8 response options. Responses are scored from 1 to 6. 1 'yes, without difficulty'; 2 'yes, with very little difficulty', 3 'yes, with some difficulty', 4 'yes, with great difficulty', 5 'almost impossible' and 'using only the unaffected hand' (same score for both responses) and 6 'impossible'. The eighth response option 'did not do this activity in the last 7 days' is not included in the scoring. The total HDISS-DU score is calculated as the average of the scores of the questions where the eighth option was not given as an answer (threshold for questions with an eighth answer \<12 questions). The total score ranges from a minimum of 1 point to a maximum of 6 points.

次要结局

  • Scleroderma Health Assessment Questionnaire(Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.)
  • Cochin 17-Item Scleroderma Functional Scale(Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.)

研究者

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

Zülal TATAR

Researcher

Pamukkale University

研究点 (2)

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