Clinical trial NCT04852159: Translation of the Cerebral Palsy Quality of Life Questionnaire in Local Languages of Pakistan.
Official title: Test of Reliability and Validity of the Cerebral Palsy Quality of Life Questionnaire in Local Languages of Pakistan.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Keywords: CP, cerebral palsy, children, quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 525
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 525

Brief summary: 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.

Detailed description: 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.)

Eligibility criteria: Inclusion Criteria:

* Children aged 9 to 12 years.

  * Children who are diagnosed with cerebral palsy.
  * Children who are able to read.

Exclusion Criteria:

* Children suffering from neurodegenerative diseases or psychiatric illness

Primary outcomes:
measure: CP QOL Child Self report version.
timeFrame: 8 months
Secondary outcomes:
measure: Reliability of translated versions of CP QOL Child
timeFrame: 8 months
measure: Validity of translated versions of CP QOL Child
timeFrame: 8 months
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Ali Muhammad Memorial
state: Punjab
Study officials:
affiliation: Riphah International University
name: Imran Amjad, PhD
role: PRINCIPAL_INVESTIGATOR
References: