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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

2026年6月12日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

80

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • トルコ（Türkiye）
    • Istanbul
      • Istanbul、Istanbul、トルコ（Türkiye）、34015
        • 募集
        • Biruni University
        • コンタクト：
          • Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
          • 電話番号：+905392870087
          • メール：fahrib@biruni.edu.tr
        • コンタクト：
        • 主任研究者：
          • Zeynep Hosbay, Physiotherapist, Prof.
        • 副調査官：
          • Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
        • 副調査官：
          • Gulsena Utku Umut, Physiotherapist, PhD
        • 副調査官：
          • Busra Ulker Eksi, Physiotherapist, PhD
        • 副調査官：
          • Hayri Omer Berkoz, MD, Assoc. Prof.
        • 副調査官：
          • Atakan Aydin, MD, Prof.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
診断テスト：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.
診断テスト：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Pain Intensity at Rest, During Activity, and at Night
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Upper Extremity Range of Motion
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Biruni University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年6月12日

QC基準を満たした最初の提出物

2026年6月12日

最初の投稿 (実際)

2026年6月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月17日

QC基準を満たした最後の更新が送信されました

2026年6月12日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2024-BİAEK/19-40

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

腕神経叢麻痺の臨床試験

Clinical Assessment Batteryの臨床試験

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