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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07655271
Enrollment
80
Registered
2026-06-17
Start date
2026-07-01
Completion date
2026-12-01
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Birth Palsy, Brachial Plexus Palsy, Brachial Plexus Palsy Due to Birth Trauma

Keywords

Obstetric Brachial Plexus Palsy, Brachial Plexus Birth Palsy, Adults, Long-Term Outcomes In Adulthood, Modified Hoffer Technique, Tendon Transfer, Upper Extremity Function, Pain, Range Of Motion, Muscle Strength, Functional Status, Social Appearance Anxiety, Role Performance

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTClinical 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.

Sponsors

Biruni University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Intensity at Rest, During Activity, and at NightBaselinePain 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

MeasureTime frameDescription
Upper Extremity Range of MotionBaselineUpper 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.
Upper Extremity Muscle StrengthBaselineUpper 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.
Shoulder Pain and DisabilityBaselineShoulder pain and disability will be assessed using the Shoulder Pain and Disability Index. Higher scores indicate greater shoulder pain and disability.
Upper Extremity DisabilityBaselineUpper extremity disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. Higher scores indicate greater upper extremity disability.
Social Appearance AnxietyBaselineSocial appearance anxiety will be assessed using the Social Appearance Anxiety Scale. Higher scores indicate greater social appearance anxiety.
Role and Activity PerformanceBaselineRole 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026