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Validity and Reliability of the Turkish Version of the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ)

13. Juni 2026 aktualisiert von: Fahri Doğukan Bozkurt, Biruni University
The aim of this methodological study is to translate the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) into Turkish, culturally adapt it, and evaluate its validity and reliability for use in adults with brachial plexus birth palsy. The study will include 50 adult participants aged 18 years and older with a diagnosis of brachial plexus birth palsy. Participants will complete the Turkish version of the IMBPIQ, as well as the Disabilities of the Arm, Shoulder and Hand questionnaire and the Short Form-36. The psychometric properties of the Turkish IMBPIQ will be examined using reliability and validity analyses, including internal consistency, test-retest reliability, and construct validity.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

50

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
  • Telefonnummer: +905392870087
  • E-Mail: fahrib@biruni.edu.tr

Studieren Sie die Kontaktsicherung

Studienorte

  • Türkei (türkiye)
    • Istanbul
      • Istanbul, Istanbul, Türkei (türkiye), 34015
        • Rekrutierung
        • Biruni University
        • Kontakt:
          • Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
          • Telefonnummer: +905392870087
          • E-Mail: fahrib@biruni.edu.tr
        • Kontakt:
        • Hauptermittler:
          • Zeynep Hosbay, Physiotherapist, Prof.
        • Unterermittler:
          • Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
        • Unterermittler:
          • Gulsena Utku Umut, Physiotherapist, PhD
        • Unterermittler:
          • Busra Ulker Eksi, Physiotherapist, PhD
        • Unterermittler:
          • Hayri Omer Berkoz, MD, Assoc. Prof.
        • Unterermittler:
          • Atakan Aydin, MD, Prof.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

The study population will consist of adults aged 18 years and older with a diagnosis of brachial plexus birth palsy who are able to read, write, speak, and understand Turkish. Participants will be recruited on a voluntary basis from individuals with brachial plexus birth palsy who meet the eligibility criteria. Both female and male participants will be included.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: Questionnaire Assessment Battery
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Validity and Reliability of the Turkish IMBPIQ
Zeitfenster: Baseline and after 1 week
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.
Baseline and after 1 week

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Upper Extremity Disability
Zeitfenster: Baseline
Upper extremity disability will be assessed using the Disabilities of the Arm, Shoulder and Hand questionnaire. Higher scores indicate greater upper extremity disability.
Baseline
Health-Related Quality of Life
Zeitfenster: Baseline
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.
Baseline

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Biruni University

Ermittler

  • Studienleiter: Zeynep Hosbay, Physiotherapist, Prof., Biruni University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

13. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juni 2026

Zuerst gepostet (Tatsächlich)

17. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 2024-BİAEK/19-38

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared in order to protect participant privacy, confidentiality, and ethical data protection principles.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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