NCT04852159

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
525

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

April 10, 2021

Last Update Submit

February 4, 2022

Conditions

Keywords

CP, cerebral palsy, children, quality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Reliability of translated versions of CP QOL Child

    8 months

  • Validity of translated versions of CP QOL Child

    8 months

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

525

You may qualify if:

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

You may not qualify if:

  • Children suffering from neurodegenerative diseases or psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali Muhammad Memorial

Multan, Punjab Province, 60000, Pakistan

RECRUITING

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Imran Amjad, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gul Andama, MS-NMPT*

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 21, 2021

Study Start

March 10, 2021

Primary Completion

April 22, 2022

Study Completion

April 30, 2022

Last Updated

February 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations