- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Ayşe Gül Türkmenoğlu, BSc, PT
- Telefonnummer: +90 537 555 69 11
- E-post: aysegulturkmenoglu@ogr.iuc.edu.tr
Studieorter
-
-
Istanbul
-
Istanbul, Istanbul, Turkiet (Türkiye)
- Rekrytering
- Istanbul University-Cerrahpasa, Faculty of Health Sciences
-
Kontakt:
- Ayşe Gül Türkmenoğlu, BSc, PT
- Telefonnummer: +905375556911
- E-post: aysegulturkmenoglu@ogr.iuc.edu.tr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Parents or primary caregivers of children aged 2 to 7 years diagnosed with cerebral palsy, applying to Yıldız Special Education and Rehabilitation Center.
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: CROSS_SECTIONAL
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Turkish Version of the ABILHAND-Kids Young CP Scale Score
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Children's Hand Use Experience Questionnaire (CHEQ) Score
Tidsram: 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)
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Manual Ability Classification System (MACS)
Tidsram: At baseline
|
At baseline
|
|
Mini-Manual Ability Classification System ( Mini-MACS)
Tidsram: At baseline
|
At baseline
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sezen Karabörklü Argut, Study Principal Investigator, Istanbul University-Cerrahpasa, Faculty of Health Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IstanbulUC
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