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临床试验/CTRI/2024/05/068175
CTRI/2024/05/068175已完成不适用

Development and Validation of Hindi Hand Function Assessment Tool in Rheumatoid Arthritis Patients

MAEERs Physiotherapy College1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
1
主要终点
content and construct validity

研究概览

简要总结

Introduction: Many complex hand function tests are available to assess function in individuals with RA. however, do not comprehensively assess Indian scenario ADLs, Environmental factors, and household chores. No Hindi version currently exists despite being the most spoken (43.63%) language in India. This Cultural diversity necessitates the development of a culturally sensitive Hand assessment scale for RA patients with an Indian cultural background

Purpose: To Develop & Validate the Indian Hand Function Assessment Tool in Hindi-speaking RA patients

b)    Materials & Methods:

Study Design: Cross-sectional (validation study), Study Setting: PAN India (Rheumatoid arthritis societies, OPD settings).After focus group discussion Items will be generated and after expert panel consensus via the Delphi method preliminary questionnaire will be prepared..Content validity will be assessed using CVR & Face validity will be assessed by Item Impact score. pretesting will be done on 30 RA patients and the final version will be tested for measurement properties for construct validity (Spearman’s Correlation Coefficient) with Hindi DASH & VAS, Reliability (ICC), Internal consistency (Cronbach’s Alpha) in 250 Hindi-speaking Rheumatoid Arthritis patients.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Clinically diagnosed RA patients with hand & wrist involvement RA stage 2 & 3 Disease duration more than 1 year patient who can understand and speak Hindi.

排除标准

  • Patients with Neurological disorders Neuropathies recent upper limb surgery (less than 1 year) Recent upper limb trauma (less than 1 yr) patient who cant participate in repeated measures Any other inflammatory joint diseases cervical radiculopathy and spondylosis.

结局指标

主要结局

content and construct validity

时间窗: Baseline

次要结局

  • Reliability(Baseline and Day 7)

研究者

发起方
MAEERs Physiotherapy College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Neetu Mahapatra

MAEERS physiotherapy college

研究点 (1)

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