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临床试验/CTRI/2024/10/074964
CTRI/2024/10/074964尚未招募不适用

Translation, cross-cultural adaptation and establishment of psychometric properties of the Gujarati version of Kujala patellofemoral score in subjects with anterior knee pain

SPB Physiotherapy College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
KUJALA PATELLOFEMORAL SCORE

研究概览

简要总结

Translation, cross-cultural adaptation and establishment of psychometric properties of the Gujarati version of Kujala patellofemoral score in subjects with anterior knee pain

Ethical clearance will be obtained from the institutional ethics committee, adhering to the Declaration of Helsinki. Subjects with anterior knee pain, diagnosed by an orthopaedic surgeon, will be included based on specific criteria. All participants will provide written informed consent and demographic information.

Phase 1: Translation and Cross-Cultural Adaptation

The Kujala Patellofemoral Score (KPS) will be translated into Gujarati using a methodical process. Two translations will be performed independently by an orthopaedic surgeon and a professional translator. These will be synthesized into a consensus version, which will then be back-translated into English by two Gujarati-speaking translators. Both the translations and back-translations will be reviewed in consensus meetings. The nearly final Gujarati version will be pre-tested with 30 subjects experiencing anterior knee pain to ensure all items are clear and comprehensible.

Phase 2: Assessment of Psychometric Properties

  1. Reliability: The KPS-G’s test-retest reliability will be evaluated with 30 subjects who will complete the questionnaire twice, 48 hours apart.
  2. Face Validity: Assessed by asking patients if they find the scale relevant to their condition, with responses recorded as "yes" or "no."
  3. Content Validity: Evaluated by experts using a Likert scale (0-6) to assess content equivalence, relevance, and representativeness.
  4. Concurrent Validity: Measured by comparing the KPS-G with the WOMAC score.
  5. Construct Validity:
  • Convergent Validity: Assessed by comparing the KPS-G with the Lysholm knee score.
  • Divergent Validity: Assessed by comparing the KPS-G with the SF-12 questionnaire.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients, who can read, write and speak Gujarati language and English language.
  • Patients having unilateral/ bilateral anterior knee pain while any 3 of activities like while ascending/descending stairs, while squatting, while running, while cycling, while sitting with knees flexed for a prolonged duration.
  • Patients with a positive Clark‟s test.

排除标准

  • Patients with any previous knee injuries.
  • Patients who have undergone any knee surgeries previously.
  • Patients with tibiofemoral arthritis.
  • Patients diagnosed with any knee pathology like patellar tendinopathy.
  • Patients with history of patellar dislocation or subluxation.
  • Patients with communication problem.

结局指标

主要结局

KUJALA PATELLOFEMORAL SCORE

时间窗: on the same day | after 48 hours

次要结局

  • LYSHOLM KNEE SCORE(SF-12)

研究者

发起方
SPB Physiotherapy College
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Vidhi Desai

SPB Physiotherapy College

研究点 (1)

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