Cerebral PalsyNCT04852159
Translation of the Cerebral Palsy Quality of Life Questionnaire in Local Languages of Pakistan.
An observational study of Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 525 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2021to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Child
Study population: 525
Who may be able to join
- Children aged 9 to 12 years.
- Children who are diagnosed with cerebral palsy.
- Children who are able to read.
Who cannot join
- Children suffering from neurodegenerative diseases or psychiatric illness
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ali Muhammad Memorial
Multan, Punjab Province, 60000
Abdul Wahab Majid, FCPS ortho, 03216336100
Gul Andama, MS
About this study
Official title: Test of Reliability and Validity of the Cerebral Palsy Quality of Life Questionnaire in Local Languages of Pakistan.
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.
Read the 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.)
- Conditions
- Cerebral Palsy
- Keywords
- CP, cerebral palsy, children, quality of life
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (2)
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.
Measured: 8 months
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start10 Mar 2021
- Primary completion22 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852159
- Sponsor's protocol ID
- REC/00959 Gul Andama
- Status last verified
- Feb 2022
- First submitted
- 10 Apr 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of Reliability and Validity of the Cerebral Palsy Quality of Life Questionnaire in Local Languages of Pakistan.
- ClinicalTrials.gov ID
- NCT04852159
- Acronym / sponsor ID
- REC/00959 Gul Andama
- Conditions
- Cerebral Palsy
- Keywords
- CP, cerebral palsy, children, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 22 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- 525
Key inclusion criteria (3 listed)
- Children aged 9 to 12 years.
Key exclusion criteria (1 listed)
- Children suffering from neurodegenerative diseases or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CP QOL Child Self report version.
Time frame: 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.
2 secondary outcomes
Reliability of translated versions of CP QOL Child
Time frame: 8 months
Validity of translated versions of CP QOL Child
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Development and exploration of a Japanese version of the cerebral palsy quality of life for children questionnaire for primary caregivers: a pilot studyLink provided by the sponsor.
- Quality of life of Finnish children with cerebral palsyLink provided by the sponsor.
- A quality of life questionnaire for adolescents with cerebral palsy: psychometric properties of the Bengali CPQoL-teensLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Amjad, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CP QOL Child Self report version. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.