- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07894926
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale (ABILHAND-KYCTR)
The purpose of this study is to perform the Turkish translation, cross-cultural adaptation, validity, and reliability of the ABILHAND-Kids Young CP scale. This methodological and cross-sectional study aims to provide a culturally adapted and psychometrically sound assessment tool to evaluate manual ability in children aged 2 to 7 years with cerebral palsy, based on parent or primary caregiver reports.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The cross-cultural adaptation process follows international guidelines, including forward-translation, synthesis, back-translation, an expert committee review, and a pilot test. Construct validity and reliability will be evaluated using standardized statistical methods.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ayşe Gül Türkmenoğlu, BSc, PT
- Phone Number: +90 537 555 69 11
- Email: aysegulturkmenoglu@ogr.iuc.edu.tr
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye)
- Recruiting
- Istanbul University-Cerrahpasa, Faculty of Health Sciences
-
Contact:
- Ayşe Gül Türkmenoğlu, BSc, PT
- Phone Number: +905375556911
- Email: aysegulturkmenoglu@ogr.iuc.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Parents or primary caregivers of children aged 2 to 7 years diagnosed with cerebral palsy, applying to Yıldız Special Education and Rehabilitation Center.
Description
Inclusion Criteria:
- Children aged 2 to 7 years
- Confirmed diagnosis of Cerebral Palsy by a specialist physician
- Parent or primary caregiver having Turkish reading and comprehension ability
- Written informed consent provided by the parent or legal guardian
Exclusion Criteria:
- Presence of additional neurological or orthopedic conditions independently affecting manual ability other than cerebral palsy
- History of upper limb surgical intervention in the last 6 months
- Severe cognitive or behavioral problems that prevent the administration of the scale
- Incomplete or improperly filled questionnaire forms
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Parents of Children with Cerebral Palsy
Parents or primary caregivers of children aged 2 to 7 years diagnosed with cerebral palsy, participating in the Turkish cross-cultural adaptation and validation study of the ABILHAND-Kids Young CP scale. |
Administration of the Turkish version of the ABILHAND-Kids Young CP questionnaire to evaluate manual ability in children with cerebral palsy. No medical, therapeutic, or surgical intervention is applied. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Turkish Version of the ABILHAND-Kids Young CP Scale Score
Time Frame: At baseline (Day 1) and at retest (Day 10)
|
Evaluates manual ability and perceived difficulty in daily activities requiring upper limb use in children aged 2 to 7 years with cerebral palsy, based on parent or primary caregiver reports. The scale consists of 17 items, each scored on a 3-point ordinal scale (0 = impossible, 1 = difficult, 2 = easy). The total raw score ranges from 0 to 34 (converted into a linear Rasch measure from 0 to 100). Higher scores indicate better manual ability (a better outcome). |
At baseline (Day 1) and at retest (Day 10)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Hand Use Experience Questionnaire (CHEQ) Score
Time Frame: At baseline (Day 1)
|
Evaluates children's bimanual use, functional performance and participation levels in daily life activities, and strategies for using the affected hand based on parent or primary caregiver reports to assess convergent validity. The questionnaire assesses 27 bimanual activities across three subscales (Grasp Efficacy, Time Taken, and Feeling Bothered) on a 4-point ordinal scale (1 to 4), converted into linear scaled scores ranging from 0 to 100 for each subscale. Higher scores indicate better hand-use experience, higher functional performance, and less perceived difficulty (a better outcome). |
At baseline (Day 1)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Manual Ability Classification System (MACS)
Time Frame: At baseline
|
At baseline
|
|
Mini-Manual Ability Classification System ( Mini-MACS)
Time Frame: At baseline
|
At baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sezen Karabörklü Argut, Study Principal Investigator, Istanbul University-Cerrahpasa, Faculty of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulUC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.