Translation of the Cerebral Palsy Quality of Life Questionnaire in Local Languages of Pakistan.

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852159
• Other study ID #: REC/00959 Gul Andama
• Status: Recruiting
• Start date: March 10, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: February 2022
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 525
• Est. completion date: April 30, 2022
• Est. primary completion date: April 22, 2022
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Locations

Country	Name	City	State
Pakistan	Ali Muhammad Memorial	Multan	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CP QOL Child Self report version.	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.	8 months
Secondary	Reliability of translated versions of CP QOL Child	To determine the reliability of cross-culturally adapted and translated CP-QOL Child in children having cerebral palsy of respective languages. Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two intervals between different visits of the patient. Thus this will be measured through test re-test reliability.	8 months
Secondary	Validity of translated versions of CP QOL Child	To determine the validity of cross-culturally adapted and translated CP-QOL Child in children having cerebral palsy of respective languages. Validity is how accurate the results are. Thus this will be measured through various parameters to validate the translated versions as appropriate and applicable.	8 months

External Links

•   A quality of life questionnaire for adolescents with cerebral palsy: psychometric properties of the Bengali CPQoL-teens
•   Development and exploration of a Japanese version of the cerebral palsy quality of life for children questionnaire for primary caregivers: a pilot study
•   Quality of life of Finnish children with cerebral palsy