Cerebral PalsyNCT05860517
Translation and Cultural Adaptation of Caregiver Priorities and Child Health Index of Life With Disability (CPCHILD)
An observational study of Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
This is a tool translation an validation study. CPCHILD will be translated in Urdu language and it's translated version will be validated. Translated version's reliability and validity will also be assessed. The WHO guidelines for tool translation study will be followed. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 115 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2023to 15 Jul 2023
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Diagnosed cases of Cerebral palsy who fulfill the inclusion criteria with gross motor function level II, III, IV.
Who may be able to join
- Subjects diagnosed with cerebral palsy
- Age 3 to 15 years
- Gross motor function score II, III, IV
Who cannot join
- Cognitive, visual or hearing impairment
- Any comorbidity or metabolic disorders
Trial locations and contacts
1 site in 1 country.
About this study
This is a tool translation an validation study. CPCHILD will be translated in Urdu language and it's translated version will be validated. Translated version's reliability and validity will also be assessed. The WHO guidelines for tool translation study will be followed.
Read the detailed description
Phase 1: Translation Translation of English version of CPCHILD into Urdu version will be done according to the WHO guidelines.
Step I: Forward translation (one way) into target language:
A linguistic expert with bilingual (English and Urdu) expertise will translate the original English version into Urdu.
Step II: Synthesis:
An independent bilingual translator will then compare the translated version (Urdu) with the original version (English) of the instrument.
Step III: Blind Backward translation:
A blinded backward translation of initially translated version will be done. Bilingual expert with preferably having Urdu as his/her mother language will be blinded to original version, will translate Urdu version into English.
Step IV: Pretesting:
10 subjects including translators, physical therapists and researchers will fill out the questionnaire before submission of final version.
Step V: Expert (multidisciplinary) committee review:
An expert committee including translators, researchers, and health care practitioner would develop a pre-final version after reviewing all the translations.
Phase 2: Psychometric testing Full psychometric testing of the CPCHILD in individuals from the target population to revise and refine the items according to instructions and guidelines of the final version of the questionnaire in the target language as well as to establish internal consistency reliability, test-retest reliability, homogeneity, construct-related validity, criterion-related validity, factor structure, and model fit of the instrument. Data will be collected from patients on both scales to assess for validity, reliability and psychometric properties.
Reliability In the present study, the reliability of the CPCHILD will be determined by assessing test-retest reliability across repeated measures and internal consistency.
Test-retest reliability:
For test-retest reliability, the scale will be completed once a day by the same participant who keeping the same signs and symptoms. A time interval of 1 week will be allowed between the assessments. Intra class correlation coefficient (ICC) will be used to evaluate test- retest reliability.
Internal consistency:
Internal consistency is a measure of the extent to which items in a both scales are correlated (homogeneous), thus measuring the same concept.
Cronbach's alpha will be calculated to determine the internal consistency.
Content validity:
Content validity is the degree to which the content of an instrument has an adequate reflection of the construct being measured. Content validity will be assessed by determining the completeness of item responses.
Construct validity:
Construct validity refers to the extent to which scores on a particular instrument relate to other measures in a way that is consistent with theoretically derived hypotheses concerning the concepts that are being measured. Construct validity will be investigated using concurrent validity. Construct validity will be assessed by measuring the correlation between CPCHILD scale and child health questionnaire. Spearman and Pearson correlation coefficients would be calculated for determining validity.
Phase 3:
A survey would be done to assess the level of disability and health status of cerebral palsy through CPCHILD questionnaire.
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Caregiver Priorities and Child Health Index, CPCHILD, Cultural validation
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver priorities and child health index of life with disability (CPCHILD)
Priorities of caregivers along with level of health status of the Cerebral Palsy child. The score ranges from 0 to 100, 0 is the best and 100 is worst.
Measured: Baseline (one time assessment)
Health Related Quality of Life (HRQoL)
The tool is used to determine the quality of life and health status of subjects. The score ranges from 0 to 100, lower scores indicate better outcome and higher scores indicate worse outcome.
Measured: Baseline (one time assessment)
International physical activity questionnaire (IPAQ)
International physical activity questionnaire (IPAQ) is used to determine the level of physical activity in certain population. The subjects may have the levels as; inactive, minimal active, moderate and highly active depending on the scores.
Measured: Baseline (one time assessment)
Health related quality of life (HRQoL)
Health related quality of life (HRQoL) will be used to determine the quality of life in subjects with cerebral palsy
Measured: Baseline (one time assessment)
Pittsburgh Sleep questionnaire
Pittsburgh Sleep questionnaire will be use to detrmine the quality of sleep in cerebral palsy subjects.
Measured: Baseline (one time assessment)
Trunk impairment scale
Trunk impairment scale is used for trunk control. The lower the trunk control, the higher chances of disability in cerebral palsy subjects.
Measured: Baseline (one time assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start5 May 2023
- Primary completion10 Jul 2023
- Study completion15 Jul 2023
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
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiran Khushnood, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860517
- Sponsor's protocol ID
- RIPHAH/RCRS/REC/Letter-01269
- Status last verified
- Oct 2023
- First submitted
- 8 May 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Cultural Adaptation of Caregiver Priorities and Child Health Index of Life With Disability (CPCHILD)
- ClinicalTrials.gov ID
- NCT05860517
- Acronym / sponsor ID
- RIPHAH/RCRS/REC/Letter-01269
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Caregiver Priorities and Child Health Index, CPCHILD, Cultural validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 16 May 2023 (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.
This is a tool translation an validation study. CPCHILD will be translated in Urdu language and it's translated version will be validated. Translated version's reliability and validity will also be assessed. The WHO guidelines for tool translation study will be followed.
Detailed description
Phase 1: Translation Translation of English version of CPCHILD into Urdu version will be done according to the WHO guidelines.
Step I: Forward translation (one way) into target language:
A linguistic expert with bilingual (English and Urdu) expertise will translate the original English version into Urdu.
Step II: Synthesis:
An independent bilingual translator will then compare the translated version (Urdu) with the original version (English) of the instrument.
Step III: Blind Backward translation:
A blinded backward translation of initially translated version will be done. Bilingual expert with preferably having Urdu as his/her mother language will be blinded to original version, will translate Urdu version into English.
Step IV: Pretesting:
10 subjects including translators, physical therapists and researchers will fill out the questionnaire before submission of final version.
Step V: Expert (multidisciplinary) committee review:
An expert committee including translators, researchers, and health care practitioner would develop a pre-final version after reviewing all the translations.
Phase 2: Psychometric testing Full psychometric testing of the CPCHILD in individuals from the target population to revise and refine the items according to instructions and guidelines of the final version of the questionnaire in the target language as well as to establish internal consistency reliability, test-retest reliability, homogeneity, construct-related validity, criterion-related validity, factor structure, and model fit of the instrument. Data will be collected from patients on both scales to assess for validity, reliability and psychometric properties.
Reliability In the present study, the reliability of the CPCHILD will be determined by assessing test-retest reliability across repeated measures and internal consistency.
Test-retest reliability:
For test-retest reliability, the scale will be completed once a day by the same participant who keeping the same signs and symptoms. A time interval of 1 week will be allowed between the assessments. Intra class correlation coefficient (ICC) will be used to evaluate test- retest reliability.
Internal consistency:
Internal consistency is a measure of the extent to which items in a both scales are correlated (homogeneous), thus measuring the same concept.
Cronbach's alpha will be calculated to determine the internal consistency.
Content validity:
Content validity is the degree to which the content of an instrument has an adequate reflection of the construct being measured. Content validity will be assessed by determining the completeness of item responses.
Construct validity:
Construct validity refers to the extent to which scores on a particular instrument relate to other measures in a way that is consistent with theoretically derived hypotheses concerning the concepts that are being measured. Construct validity will be investigated using concurrent validity. Construct validity will be assessed by measuring the correlation between CPCHILD scale and child health questionnaire. Spearman and Pearson correlation coefficients would be calculated for determining validity.
Phase 3:
A survey would be done to assess the level of disability and health status of cerebral palsy through CPCHILD questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Diagnosed cases of Cerebral palsy who fulfill the inclusion criteria with gross motor function level II, III, IV.
Key inclusion criteria (3 listed)
- Subjects diagnosed with cerebral palsy
- Age 3 to 15 years
- Gross motor function score II, III, IV
Key exclusion criteria (2 listed)
- Cognitive, visual or hearing impairment
- Any comorbidity or metabolic disorders
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
Caregiver priorities and child health index of life with disability (CPCHILD)
Time frame: Baseline (one time assessment)
Priorities of caregivers along with level of health status of the Cerebral Palsy child. The score ranges from 0 to 100, 0 is the best and 100 is worst.
Health Related Quality of Life (HRQoL)
Time frame: Baseline (one time assessment)
The tool is used to determine the quality of life and health status of subjects. The score ranges from 0 to 100, lower scores indicate better outcome and higher scores indicate worse outcome.
International physical activity questionnaire (IPAQ)
Time frame: Baseline (one time assessment)
International physical activity questionnaire (IPAQ) is used to determine the level of physical activity in certain population. The subjects may have the levels as; inactive, minimal active, moderate and highly active depending on the scores.
Health related quality of life (HRQoL)
Time frame: Baseline (one time assessment)
Health related quality of life (HRQoL) will be used to determine the quality of life in subjects with cerebral palsy
Pittsburgh Sleep questionnaire
Time frame: Baseline (one time assessment)
Pittsburgh Sleep questionnaire will be use to detrmine the quality of sleep in cerebral palsy subjects.
Trunk impairment scale
Time frame: Baseline (one time assessment)
Trunk impairment scale is used for trunk control. The lower the trunk control, the higher chances of disability in cerebral palsy subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- 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.
Kiran Khushnood, MSNMPT 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 2 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: finished, as of the sponsor's last update on 13 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver priorities and child health index of life with disability (CPCHILD) (time frame: Baseline (one time assessment)). The study lists 6 primary outcomes in all. 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 13 Oct 2023.