- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ayşe Gül Türkmenoğlu, BSc, PT
- 전화번호: +90 537 555 69 11
- 이메일: aysegulturkmenoglu@ogr.iuc.edu.tr
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye)
- 모병
- Istanbul University-Cerrahpasa, Faculty of Health Sciences
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연락하다:
- Ayşe Gül Türkmenoğlu, BSc, PT
- 전화번호: +905375556911
- 이메일: aysegulturkmenoglu@ogr.iuc.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Parents or primary caregivers of children aged 2 to 7 years diagnosed with cerebral palsy, applying to Yıldız Special Education and Rehabilitation Center.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Turkish Version of the ABILHAND-Kids Young CP Scale Score
기간: At baseline (Day 1) and at retest (Day 10)
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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)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Children's Hand Use Experience Questionnaire (CHEQ) Score
기간: At baseline (Day 1)
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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)
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Manual Ability Classification System (MACS)
기간: At baseline
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At baseline
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Mini-Manual Ability Classification System ( Mini-MACS)
기간: At baseline
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At baseline
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sezen Karabörklü Argut, Study Principal Investigator, Istanbul University-Cerrahpasa, Faculty of Health Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .