Evaluation of Pain, Upper Extremity Function, and Social Appearance Anxiety in Adults With Obstetric Brachial Plexus Palsy Who Underwent Shoulder Tendon Transfer Surgery
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Istanbul
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Istanbul, Istanbul, Turquie (Türkiye), 34015
- Recrutement
- Biruni University
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Contact:
- Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
- Numéro de téléphone: +905392870087
- E-mail: fahrib@biruni.edu.tr
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Contact:
- Zeynep Hosbay, Physiotherapist, Prof.
- Numéro de téléphone: +905055034279
- E-mail: zhosbay@biruni.edu.tr
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Chercheur principal:
- Zeynep Hosbay, Physiotherapist, Prof.
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Sous-enquêteur:
- Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
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Sous-enquêteur:
- Gulsena Utku Umut, Physiotherapist, PhD
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Sous-enquêteur:
- Busra Ulker Eksi, Physiotherapist, PhD
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Sous-enquêteur:
- Hayri Omer Berkoz, MD, Assoc. Prof.
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Sous-enquêteur:
- Atakan Aydin, MD, Prof.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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.
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Participants will undergo a standardized clinical assessment including pain, range of motion, muscle strength, functional status, social appearance anxiety, and role/activity performance measures.
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Healthy Controls
Healthy age-matched individuals without obstetric brachial plexus palsy.
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Participants will undergo a standardized clinical assessment including pain, range of motion, muscle strength, functional status, social appearance anxiety, and role/activity performance measures.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain Intensity at Rest, During Activity, and at Night
Délai: Baseline
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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.
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Baseline
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Upper Extremity Range of Motion
Délai: Baseline
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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.
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Baseline
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Upper Extremity Muscle Strength
Délai: Baseline
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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.
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Baseline
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Shoulder Pain and Disability
Délai: Baseline
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Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index.
Higher scores indicate greater shoulder pain and disability.
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Baseline
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Upper Extremity Disability
Délai: Baseline
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Upper extremity disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire.
Higher scores indicate greater upper extremity disability.
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Baseline
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Social Appearance Anxiety
Délai: Baseline
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Social appearance anxiety will be assessed using the Social Appearance Anxiety Scale.
Higher scores indicate greater social appearance anxiety.
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Baseline
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Role and Activity Performance
Délai: Baseline
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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.
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Baseline
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2024-BİAEK/19-40
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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