NCT07654504

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

June 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 13, 2026

Last Update Submit

June 13, 2026

Conditions

Keywords

Impact of Brachial Plexus Injury QuestionnaireIMBPIQBrachial Plexus Birth PalsyObstetric Brachial Plexus PalsyTurkish VersionValidityReliabilityCultural AdaptationPatient-Reported Outcome MeasureDASHShort Form-36Test-Retest ReliabilityInternal ConsistencyConstruct Validity

Outcome Measures

Primary Outcomes (1)

  • Validity and Reliability of the Turkish IMBPIQ

    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

Secondary Outcomes (2)

  • Upper Extremity Disability

    Baseline

  • Health-Related Quality of Life

    Baseline

Study Arms (1)

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.

Other: Questionnaire Assessment Battery

Interventions

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.

Adults With Brachial Plexus Birth Palsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Istanbul, 34015, Turkey (Türkiye)

RECRUITING

Study Officials

  • Zeynep Hosbay, Physiotherapist, Prof.

    Biruni University

    STUDY DIRECTOR

Central Study Contacts

Fahri Dogukan Bozkurt, Physiotherapist, MSc Student

CONTACT

Zeynep Hosbay, Physiotherapist, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Student

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 17, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations