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临床试验/NCT04852159
NCT04852159Unknown不适用

Test of Reliability and Validity of the Cerebral Palsy Quality of Life Questionnaire in Local Languages of Pakistan.

Riphah International University1 个研究点 分布在 1 个国家目标入组 525 人开始时间: 2021年3月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
525
试验地点
1
主要终点
CP QOL Child Self report version.

研究概览

简要总结

Descriptive analytical study to translate the CP-QOL into local languages of Pakistan that are, Pashto, Urdu, Punjabi, Sindhi and Balochi languages. Along with validation of the translated versions by evaluating their validity and reliability in the people of Pakistan, speaking respective languages and suffering from low back pain. No such study has been previously conducted in the Pakistan region which translates the scale and follows the proper cross-culture adaptation.

Condition or disease: Cerebral palsy. Non-probability Purposive Sampling would be used. The study will be conducted in relevant areas of Pakistan.

详细描述

CP QOL has two separate forms, for both the child and the primary caregiver. CP QOL- The primary caregiver proxy report consists of 66 items for children ages 4-12 years old.

The child self-report form contains 52 items for children ages 9-12 years old. The version CP QOL-Child Self Report Questionnaire (9-12 years) is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability.

This version should be answered by the children with CP, that is, it is the child's self-report.

All the items are rated from 1 to 9, except for one item in pain and impact of disability domain, which is rated on a 5-point scale. All responses will then be converted into scale score between 0 to 100. Higher scores meant a higher quality of life. In case children needed any help while filling out the questionnaires, they could easily consult caregivers or researchers. As the CP QOL-Child is a well-developed measurement scale, it is meaningful to validate its Urdu, Pushto, Punjabi, Sindhi and Balochi versions. It is also useful to study the QOL of children with CP in different cultural settings by using the same measurement items so that a more direct comparison can be made. Therefore, the aim of this study is to translate the CP QOL questionnaire in Urdu, Pushto, Punjabi, Sindhi and Balochi and also to assess the reliability and validity of this translated version of CP QOL questionnaire in Pakistan.

The translation and cultural adaptation processes would start after obtaining approval from the developer of the original CP QOL Child. This would be done according to WHO guidelines. Translation will be done by symmetrical category. The purpose will be to gain uniformity in the translation of tool in both the Target language and Source language. This will involve 5 steps. (Forward translation, synthesis 1, Back translation, synthesis 2 and pilot testing.) Phase 2 would be done according to the guidelines of COSMIN in which psychometric properties will be measured. (reliability, internal consistency, construct validity and factor analysis.)

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
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children aged 9 to 12 years.
  • •Children who are diagnosed with cerebral palsy.
  • •Children who are able to read.

排除标准

  • •Children suffering from neurodegenerative diseases or psychiatric illness

结局指标

主要结局

CP QOL Child Self report version.

时间窗: 8 months

The child self-report form contains 52 items for children ages 9-12 years old. The version CP QOL-Child Self Report Questionnaire (9-12 years) is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability. All the items are rated from 1 to 9, except for one item in pain and impact of disability domain, which is rated on a 5-point scale. All responses will then be converted into scale score between 0 to 100. Higher scores meant a higher quality of life. In case children needed any help while filling out the questionnaires, they could easily consult caregivers or researchers. The total score is 100, the minimum score is 0 and the maximum score is 100.

次要结局

  • Reliability of translated versions of CP QOL Child(8 months)
  • Validity of translated versions of CP QOL Child(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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