- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07654504
Validity and Reliability of the Turkish Version of the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ)
연구 개요
상태
상세 설명
The Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) is a disease-specific patient-reported outcome measure developed to evaluate the impact of brachial plexus injury on daily life, functional status, and psychosocial well-being. There is currently no Turkish version of the IMBPIQ with established validity and reliability. Considering the increasing importance of culturally adapted patient-reported outcome measures, this study aims to translate the IMBPIQ into Turkish, perform its cultural adaptation, and evaluate the validity and reliability of the Turkish version for use in adults with brachial plexus birth palsy.
This study is designed as a methodological validity and reliability study. Written permission has been obtained from the original developers of the IMBPIQ for translation, cultural adaptation, and psychometric testing. The English version of the questionnaire will be translated into Turkish by independent translators. The translated versions will be reviewed by a committee, and a single Turkish version will be created based on consensus. This Turkish version will then be back-translated into English by a translator whose native language is English and who is proficient in both languages. The original version and the back-translated version will be compared in terms of semantic equivalence, linguistic appropriateness, and cultural adaptation, and the final Turkish version of the questionnaire will be established.
A pilot test will be conducted with 10 participants to evaluate the comprehensibility and applicability of the Turkish version of the questionnaire. Based on the feedback obtained from the pilot test, final revisions will be made before the main study. The main study will include 50 adult participants aged 18 years and older with a diagnosis of brachial plexus birth palsy. Participants will complete a sociodemographic and clinical information form, the Turkish version of the IMBPIQ, the Disabilities of the Arm, Shoulder and Hand questionnaire, and the Short Form-36.
The IMBPIQ consists of 43 items and includes four main subdomains: symptoms, limitations, emotional status, and expected or achieved improvement after surgery or treatment. Raw scores obtained from the responses are converted into normalized standard scores ranging from 0 to 100. The disability domain score is calculated using the symptoms, limitations, and emotional status subdomains, with higher scores indicating greater disability and psychosocial impact. The improvement domain score reflects the expected or achieved improvement related to surgery or treatment, with higher scores indicating greater expected or perceived improvement.
The Disabilities of the Arm, Shoulder and Hand questionnaire will be used to evaluate upper extremity symptoms and functional disability. The Short Form-36 will be used to assess health-related quality of life. These measures will be used to examine the construct validity of the Turkish IMBPIQ through correlations with related patient-reported outcome measures.
Statistical analyses will be performed using IBM SPSS Statistics software. Descriptive statistics will be calculated to summarize participants' sociodemographic and clinical characteristics. Internal consistency reliability will be evaluated using Cronbach's alpha coefficient. Test-retest reliability will be examined by re-administering the Turkish IMBPIQ to 30 participants after a two-week interval, and agreement between the two assessments will be analyzed using the intraclass correlation coefficient. Construct validity will be assessed using Pearson or Spearman correlation analyses between the IMBPIQ scores and the scores obtained from the Disabilities of the Arm, Shoulder and Hand questionnaire and the Short Form-36. The statistical significance level will be accepted as p < 0.05.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
- 전화번호: +905392870087
- 이메일: fahrib@biruni.edu.tr
연구 연락처 백업
- 이름: Zeynep Hosbay, Physiotherapist, Prof.
- 전화번호: +905055034279
- 이메일: zhosbay@biruni.edu.tr
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34015
- 모병
- Biruni University
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연락하다:
- Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
- 전화번호: +905392870087
- 이메일: fahrib@biruni.edu.tr
-
연락하다:
- Zeynep Hosbay, Physiotherapist, Prof.
- 전화번호: +905055034279
- 이메일: zhosbay@biruni.edu.tr
-
수석 연구원:
- Zeynep Hosbay, Physiotherapist, Prof.
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부수사관:
- Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
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부수사관:
- Gulsena Utku Umut, Physiotherapist, PhD
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부수사관:
- Busra Ulker Eksi, Physiotherapist, PhD
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부수사관:
- Hayri Omer Berkoz, MD, Assoc. Prof.
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부수사관:
- Atakan Aydin, MD, Prof.
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Being 18 years of age or older.
- Having a diagnosis of brachial plexus birth palsy.
- Having the ability to read, write, speak, and understand Turkish.
- Agreeing to participate voluntarily in the study and signing the informed consent form.
Exclusion Criteria:
- Having a neurological disease.
- Having another orthopedic problem or a history of trauma in the affected upper extremity.
- Having a severe cognitive or communication impairment that may prevent completion of the questionnaires or understanding of the study instructions.
- Having a history of systemic disease requiring an acute attack or hospitalization within the last three months.
- Being pregnant or being in the postpartum period of less than 6 months.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Adults With Brachial Plexus Birth Palsy
Adults aged 18 years and older with a diagnosis of brachial plexus birth palsy who will complete the Turkish version of the Impact of Brachial Plexus Injury Questionnaire and related assessment tools.
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Participants will complete the Turkish version of the Impact of Brachial Plexus Injury Questionnaire, the Disabilities of the Arm, Shoulder and Hand questionnaire, and the Short Form-36.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Validity and Reliability of the Turkish IMBPIQ
기간: Baseline and after 1 week
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The validity and reliability of the Turkish version of the Impact of Brachial Plexus Injury Questionnaire will be evaluated.
Reliability will be assessed using internal consistency and test-retest reliability analyses.
Validity will be assessed using construct validity analyses through correlations with related patient-reported outcome measures.
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Baseline and after 1 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Upper Extremity Disability
기간: Baseline
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Upper extremity disability will be assessed using the Disabilities of the Arm, Shoulder and Hand questionnaire.
Higher scores indicate greater upper extremity disability.
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Baseline
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Health-Related Quality of Life
기간: Baseline
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Health-related quality of life will be assessed using the Short Form-36.
The scale includes subdomains related to physical and mental health, with higher scores indicating better health status.
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Baseline
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공동 작업자 및 조사자
수사관
- 연구 책임자: Zeynep Hosbay, Physiotherapist, Prof., Biruni University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2024-BİAEK/19-38
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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-
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