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NCT Number: NCT07655271

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biruni University

Istanbul, 34015, Turkey (Türkiye)

Location status: Recruiting

Location contact

Atakan Aydin, MD, Prof.

SUB_INVESTIGATOR

Busra Ulker Eksi, Physiotherapist, PhD

SUB_INVESTIGATOR

Fahri Dogukan Bozkurt, Physiotherapist, MSc Student

CONTACT

[email protected]

+905392870087

Fahri Dogukan Bozkurt, Physiotherapist, MSc Student

SUB_INVESTIGATOR

Gulsena Utku Umut, Physiotherapist, PhD

SUB_INVESTIGATOR

Hayri Omer Berkoz, MD, Assoc. Prof.

SUB_INVESTIGATOR

Zeynep Hosbay, Physiotherapist, Prof.

CONTACT

[email protected]

+905055034279

Zeynep Hosbay, Physiotherapist, Prof.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Assessment Battery

Diagnostic Test

Participants will undergo a standardized clinical assessment including pain, range of motion, muscle strength, functional status, social appearance anxiety, and role/activity performance measures.

Primary outcomes

  1. Pain Intensity at Rest, During Activity, and at Night

    Time frame: 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.

Secondary outcomes

  1. Upper Extremity Range of Motion

    Time frame: 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.

  2. Upper Extremity Muscle Strength

    Time frame: 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.

  3. Shoulder Pain and Disability

    Time frame: Baseline

    Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index. Higher scores indicate greater shoulder pain and disability.

  4. Upper Extremity Disability

    Time frame: 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.

  5. Social Appearance Anxiety

    Time frame: Baseline

    Social appearance anxiety will be assessed using the Social Appearance Anxiety Scale. Higher scores indicate greater social appearance anxiety.

  6. Role and Activity Performance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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