跳至主要内容
临床试验/CTRI/2025/07/090141
CTRI/2025/07/090141招募中不适用

Development and validation of a questionnaire to evaluate the return to preinjury level in non-athletic individuals following Anterior Cruciate Ligament Reconstruction among Indian population

Jawaharlal Institute of Postgraduate Medical Education and Research, pondicherry1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
105
试验地点
1
主要终点
A new questionnaire will be developed to study the return to pre-injury levels in postoperative Anterior Cruciate Ligament patients in the Indian

研究概览

简要总结

The study aims to help develop and validate a new questionnaire to evaluate the return to pre-injury level in non-athletes following ACL reconstruction surgery. The study is indicated for the reason that, despite having numerous scales and scoring systems to study return to sports, none of the questionnaires shed any light on non-sports-related activities of daily living or occupational activities. Most studies are inspired by and benefit high-demand patients (sportspersons).

Moreover, cultural and social factors greatly influence the recovery of patients and also affect activities of daily living (ADLs). Indian patients, who are in the habit of sitting cross-legged and squatting, will be fearful to do so post-operatively, but these factors are not taken into account in the pre-existing questionnaires.

After IEC approval, the study will proceed with expert validation involving approximately 10 orthopedicians, physiatrists, and physiotherapists, who will assess the questionnaire items for representativeness, clarity, relevance, and distribution using established quantitative indices, such as the Content Validity Ratio and Content Validity Index. Following this, cognitive interviews with approximately 10 participants will be conducted to ensure that the items are interpreted as intended and to validate the response process. The refined questionnaire will then be pilot tested with 75 patients, each at least one year post-ACL reconstruction, to evaluate its practicality and gather user feedback. Finally, data from the pilot will undergo exploratory and confirmatory factor analyses to determine the questionnaire’s structural validity, and reliability will be assessed using Cronbach’s alpha to ensure internal consistency of the scale.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Non-athletic individuals between 18-40 years who underwent ACL- reconstruction and completed at least 1year follow-up.

排除标准

  • 1.Patient with associated PCL injury
  • Associated grade 3 collateral injury
  • Individuals with coexisting other Musculo skeletal or other neurological problems in the lower limb.

结局指标

主要结局

A new questionnaire will be developed to study the return to pre-injury levels in postoperative Anterior Cruciate Ligament patients in the Indian

时间窗: 9 month to 12 month post operative period

population.

时间窗: 9 month to 12 month post operative period

the developed questionarre will be validated against preexisting questionares

时间窗: 9 month to 12 month post operative period

次要结局

未报告次要终点

研究者

发起方
Jawaharlal Institute of Postgraduate Medical Education and Research, pondicherry
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shubhra Mandal

Jawaharlal Institute of Postgraduate Medical Education and Research,Pondicherry

研究点 (1)

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