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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

80

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkije (Türkiye), 34015
        • Werving
        • Biruni University
        • Contact:
          • Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
          • Telefoonnummer: +905392870087
          • E-mail: fahrib@biruni.edu.tr
        • Contact:
        • Hoofdonderzoeker:
          • Zeynep Hosbay, Physiotherapist, Prof.
        • Onderonderzoeker:
          • Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
        • Onderonderzoeker:
          • Gulsena Utku Umut, Physiotherapist, PhD
        • Onderonderzoeker:
          • Busra Ulker Eksi, Physiotherapist, PhD
        • Onderonderzoeker:
          • Hayri Omer Berkoz, MD, Assoc. Prof.
        • Onderonderzoeker:
          • Atakan Aydin, MD, Prof.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Diagnostische toets: 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.
Diagnostische toets: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Intensity at Rest, During Activity, and at Night
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Upper Extremity Range of Motion
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Biruni University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

12 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2026

Eerst geplaatst (Werkelijk)

17 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2024-BİAEK/19-40

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Brachiale Plexus Parese

Klinische onderzoeken op Clinical Assessment Battery

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