NCT05313698

Brief Summary

Functional impairment of the upper extremities can impair the health-related quality of life (HRQOL) of persons with Cerebral Palsy CP. Health-related quality of life (HRQOL) measures several subjective dimensions dealing with the impact of health or illness on physical and psychosocial functioning. Quality of life (QOL) measures for children and adolescents have been developed in recent years, initially for children with specific chronic conditions, but more recently generic and health-related QOL (HRQOL) measures have been developed . The early assessments of children's quality of life were mostly disease-specific, and this trend has continued. Generic HRQOL measurements for children and adolescents can help identify subgroups of children and adolescents who are at risk of developing health problems. KIDSCREEN-27 is a generic HRQOL measure derived from KIDSCREEN-52. The KIDSCREEN-27 is a subset of the KIDSCREEN-52 that includes 27 items for assessing HRQOL across five dimensions: Physical Well-Being (5 items) examines a child's or adolescent's level of physical activity, energy, and fitness. Although the psychometric properties of the Turkish version of the KIDSCREEN forms have been studied previously; however, its psychometric characteristics in children with CP have yet to be determined. Accordingly, the aim of this study is to provide an overview of the psychometric results of the KIDSCREEN-27 HRQOL questionnaire

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

June 3, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

March 22, 2022

Last Update Submit

May 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Consistency from baseline in mean scores of KIDSCREEN-27 at week 2

    The KIDSCREEN-27 is a 27-item variation of the KIDSCREEN-52 questionnaire that includes five dimensions of health-related quality of life (HRQOL). It is a valid and reliable tool for assessing children's and adolescents' HRQOL outcomes

    Change from Baseline KIDCREEN-27 mean scores at 2 weeks

Interventions

No interventionDIAGNOSTIC_TEST

cross-sectional study/psychometric study

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with all typologies of cerebral palsy and their parents/caregivers

You may qualify if:

  • Children with cerebral palsy who have sufficient intellectual level to answer KIDSCREEN-27' items

You may not qualify if:

  • children with severe intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mintaze KEREM GUNLE

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 6, 2022

Study Start

January 1, 2022

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

June 3, 2022

Record last verified: 2022-05

Locations