Validity and Reliability of the Turkish Version of the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
- Número de teléfono: +905392870087
- Correo electrónico: fahrib@biruni.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Zeynep Hosbay, Physiotherapist, Prof.
- Número de teléfono: +905055034279
- Correo electrónico: zhosbay@biruni.edu.tr
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34015
- Reclutamiento
- Biruni University
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Contacto:
- Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
- Número de teléfono: +905392870087
- Correo electrónico: fahrib@biruni.edu.tr
-
Contacto:
- Zeynep Hosbay, Physiotherapist, Prof.
- Número de teléfono: +905055034279
- Correo electrónico: zhosbay@biruni.edu.tr
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Investigador principal:
- Zeynep Hosbay, Physiotherapist, Prof.
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Sub-Investigador:
- Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
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Sub-Investigador:
- Gulsena Utku Umut, Physiotherapist, PhD
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Sub-Investigador:
- Busra Ulker Eksi, Physiotherapist, PhD
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Sub-Investigador:
- Hayri Omer Berkoz, MD, Assoc. Prof.
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Sub-Investigador:
- Atakan Aydin, MD, Prof.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Validity and Reliability of the Turkish IMBPIQ
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Upper Extremity Disability
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Zeynep Hosbay, Physiotherapist, Prof., Biruni University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Validez
- Fiabilidad
- ESTRELLARSE
- Adaptación Cultural
- Parálisis obstétrica del plexo braquial
- Validez de construcción
- Forma corta-36
- Versión turca
- Fiabilidad de prueba y repetición
- Brachial Plexus Birth Palsy
- Impact of Brachial Plexus Injury Questionnaire
- IMBPIQ
- Patient-Reported Outcome Measure
- Internal Consistency
Otros números de identificación del estudio
- 2024-BİAEK/19-38
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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