- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Ayşe Gül Türkmenoğlu, BSc, PT
- Telefonnummer: +90 537 555 69 11
- E-post: aysegulturkmenoglu@ogr.iuc.edu.tr
Studiesteder
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-
Istanbul
-
Istanbul, Istanbul, Tyrkia (Türkiye)
- Rekruttering
- Istanbul University-Cerrahpasa, Faculty of Health Sciences
-
Ta kontakt med:
- Ayşe Gül Türkmenoğlu, BSc, PT
- Telefonnummer: +905375556911
- E-post: aysegulturkmenoglu@ogr.iuc.edu.tr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Parents or primary caregivers of children aged 2 to 7 years diagnosed with cerebral palsy, applying to Yıldız Special Education and Rehabilitation Center.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Turkish Version of the ABILHAND-Kids Young CP Scale Score
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Children's Hand Use Experience Questionnaire (CHEQ) Score
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Manual Ability Classification System (MACS)
Tidsramme: At baseline
|
At baseline
|
|
Mini-Manual Ability Classification System ( Mini-MACS)
Tidsramme: At baseline
|
At baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sezen Karabörklü Argut, Study Principal Investigator, Istanbul University-Cerrahpasa, Faculty of Health Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IstanbulUC
Plan for individuelle deltakerdata (IPD)
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