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Evaluation of Pain, Upper Extremity Function, and Social Appearance Anxiety in Adults With Obstetric Brachial Plexus Palsy Who Underwent Shoulder Tendon Transfer Surgery

12. juni 2026 opdateret af: Fahri Doğukan Bozkurt, Biruni University
This observational study aims to evaluate pain and upper extremity function in adults with obstetric brachial plexus palsy who underwent shoulder tendon transfer surgery using the Modified Hoffer technique during childhood. Data on the long-term clinical outcomes of this surgical procedure in adulthood are limited. Participants with obstetric brachial plexus palsy and healthy age-matched individuals will be assessed in a single session. The evaluations will include pain, range of motion, muscle strength, upper extremity functional status, social appearance anxiety, and role performance. The study aims to describe the clinical profile of adults with obstetric brachial plexus palsy after Modified Hoffer tendon transfer and compare their outcomes with healthy peers.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is designed as a master's thesis and will be conducted as an observational, cross-sectional, assessment-based study. The study will be carried out at the Department of Physiotherapy and Rehabilitation, Biruni University. Ethical approval has been obtained from the Biruni University Scientific Research Ethics Committee. The study will be conducted in accordance with the principles of the Declaration of Helsinki, and written informed consent will be obtained from all participants before participation.

The study will include adults with obstetric brachial plexus palsy who underwent shoulder tendon transfer surgery using the Modified Hoffer technique during childhood and healthy age-matched individuals. Individuals with obstetric brachial plexus palsy who have had at least five years since surgery will be included. Participants will be recruited on a voluntary basis among individuals referred by physicians, followed clinically, or admitted to the Department of Physiotherapy and Rehabilitation at Biruni University. All assessments will be performed by the same researcher in the Patient Assessment Laboratory of the Department of Physiotherapy and Rehabilitation.

The primary outcome of the study is pain. Pain intensity will be assessed using the Numeric Rating Scale. Secondary outcomes will include upper extremity range of motion, muscle strength, functional status, social appearance anxiety, and role/activity performance. Shoulder and forearm range of motion will be assessed for flexion, abduction, external rotation, internal rotation, supination, and pronation using the Kinvent K-Move Digital Goniometer. Muscle strength will be assessed using the MicroFET-2 digital handheld dynamometer for the relevant primary muscle groups of the shoulder and forearm.

Functional status will be evaluated using the Shoulder Pain and Disability Index and the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. Social appearance anxiety will be assessed using the Social Appearance Anxiety Scale. Role performance and perceived activity performance will be evaluated using the Canadian Occupational Performance Measure.

To ensure methodological consistency between the obstetric brachial plexus palsy group and the healthy control group, the same standardized assessment battery will be applied to both groups. Physical and functional upper extremity measurements will be recorded bilaterally to allow comparison between the affected and unaffected sides in individuals with obstetric brachial plexus palsy and between the dominant and non-dominant sides in healthy controls.

The study aims to describe the clinical profile of adults with obstetric brachial plexus palsy after Modified Hoffer tendon transfer and to compare their pain, upper extremity function, range of motion, muscle strength, psychosocial status, and role performance with those of healthy peers.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

80

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34015
        • Rekruttering
        • Biruni University
        • Kontakt:
          • Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
          • Telefonnummer: +905392870087
          • E-mail: fahrib@biruni.edu.tr
        • Kontakt:
        • Ledende efterforsker:
          • Zeynep Hosbay, Physiotherapist, Prof.
        • Underforsker:
          • Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
        • Underforsker:
          • Gulsena Utku Umut, Physiotherapist, PhD
        • Underforsker:
          • Busra Ulker Eksi, Physiotherapist, PhD
        • Underforsker:
          • Hayri Omer Berkoz, MD, Assoc. Prof.
        • Underforsker:
          • Atakan Aydin, MD, Prof.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will consist of adults aged 18 to 40 years with unilateral brachial plexus birth palsy who underwent shoulder tendon transfer surgery using the Modified Hoffer Technique, and healthy age-matched individuals. Participants with brachial plexus birth palsy will be recruited from individuals referred by physicians, followed clinically, or admitted to the Department of Physiotherapy and Rehabilitation at Biruni University. Healthy controls will be recruited on a voluntary basis from individuals without brachial plexus birth palsy or upper extremity conditions that may affect the assessments.

Beskrivelse

Inclusion and Exclusion Criteria

Inclusion Criteria for Individuals With Brachial Plexus Birth Palsy:

  • Being between 18 and 40 years of age.
  • Having a diagnosis of unilateral brachial plexus birth palsy.
  • Having undergone shoulder tendon transfer surgery using the Modified Hoffer Technique.
  • Having at least 5 years elapsed since the last surgery.
  • Having a cognitive and communication level sufficient to comply with the assessment process.
  • Agreeing to participate voluntarily in the study and signing the informed consent form.

Inclusion Criteria for Healthy Individuals:

  • Being between 18 and 40 years of age.
  • Having no history of upper extremity-related surgery within the last 5 years.
  • Having a cognitive and communication level sufficient to comply with the assessment process.
  • Agreeing to participate voluntarily in the study and signing the informed consent form.

Exclusion Criteria for All Participants:

  • Having a neurological disease.
  • Having another orthopedic problem or a history of trauma in the affected upper extremity.
  • Having a history of systemic disease requiring an acute attack or hospitalization within the last 3 months.
  • Pregnancy or being less than 6 months postpartum.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Adults With Brachial Plexus Birth Palsy
Adults with obstetric brachial plexus palsy who underwent shoulder tendon transfer surgery using the Modified Hoffer technique during childhood.
Diagnostisk test: Clinical Assessment Battery
Participants will undergo a standardized clinical assessment including pain, range of motion, muscle strength, functional status, social appearance anxiety, and role/activity performance measures.
Healthy Controls
Healthy age-matched individuals without obstetric brachial plexus palsy.
Diagnostisk test: Clinical Assessment Battery
Participants will undergo a standardized clinical assessment including pain, range of motion, muscle strength, functional status, social appearance anxiety, and role/activity performance measures.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Intensity at Rest, During Activity, and at Night
Tidsramme: Baseline
Pain intensity will be assessed using the Numeric Rating Scale under three conditions: pain at rest, pain during activity, and pain at night. Participants will rate their pain from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Upper Extremity Range of Motion
Tidsramme: Baseline
Upper extremity range of motion will be assessed using the Kinvent K-Move Digital Goniometer. Shoulder flexion, shoulder extension, shoulder abduction, shoulder external rotation, shoulder internal rotation, elbow flexion, elbow extension, forearm supination, forearm pronation, wrist flexion, and wrist extension will be measured bilaterally.
Baseline
Upper Extremity Muscle Strength
Tidsramme: Baseline
Upper extremity muscle strength will be assessed using the MicroFET-2 digital handheld dynamometer. The relevant primary muscle groups of the shoulder, elbow, forearm, and wrist will be measured bilaterally.
Baseline
Shoulder Pain and Disability
Tidsramme: Baseline
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index. Higher scores indicate greater shoulder pain and disability.
Baseline
Upper Extremity Disability
Tidsramme: Baseline
Upper extremity disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. Higher scores indicate greater upper extremity disability.
Baseline
Social Appearance Anxiety
Tidsramme: Baseline
Social appearance anxiety will be assessed using the Social Appearance Anxiety Scale. Higher scores indicate greater social appearance anxiety.
Baseline
Role and Activity Performance
Tidsramme: Baseline
Role and activity performance will be assessed using the Canadian Occupational Performance Measure. Importance, performance, and satisfaction scores will be recorded based on participant-identified activities.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biruni University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024-BİAEK/19-40

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Brachial Plexus Parese

Kliniske forsøg med Clinical Assessment Battery

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