Brachial Plexus Birth PalsyNCT07655271
Evaluation of Pain, Upper Extremity Function, and Social Appearance Anxiety in Adults With Obstetric Brachial Plexus Palsy Who Underwent Shoulder Tendon Transfer Surgery
An observational study of Brachial Plexus Birth Palsy and Brachial Plexus Palsy, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Birth Palsy, Brachial Plexus Palsy, Brachial Plexus Palsy Due to Birth Trauma
- What is being tested?
- Clinical Assessment Battery
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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.
Show all 11Show fewer
- Agreeing to participate voluntarily in the study and signing the informed consent form.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University
Istanbul, Istanbul, 34015
Fahri Dogukan Bozkurt, Physiotherapist, MSc Student, +905392870087, fahrib@biruni.edu.tr
Zeynep Hosbay, Physiotherapist, Prof., +905055034279, zhosbay@biruni.edu.tr
About this study
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.
Read the 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.
- Conditions
- Brachial Plexus Birth Palsy, Brachial Plexus Palsy, Brachial Plexus Palsy Due to Birth Trauma
- Being tested
- Clinical Assessment Battery
- 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
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Assessment BatteryDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Clinical Assessment Battery | |
| Healthy Controls | Healthy age-matched individuals without obstetric brachial plexus palsy. Receives: Diagnostic Test: Clinical Assessment Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity at Rest, During Activity, and at Night
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.
Measured: Baseline
Secondary outcomes (6)
Upper Extremity Range of Motion
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.
Measured: Baseline
Upper Extremity Muscle Strength
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.
Measured: Baseline
Shoulder Pain and Disability
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index. Higher scores indicate greater shoulder pain and disability.
Measured: Baseline
Upper Extremity Disability
Upper extremity disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. Higher scores indicate greater upper extremity disability.
Measured: Baseline
Social Appearance Anxiety
Social appearance anxiety will be assessed using the Social Appearance Anxiety Scale. Higher scores indicate greater social appearance anxiety.
Measured: Baseline
Role and Activity Performance
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus Birth PalsyStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahri Doğukan Bozkurt, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655271
- Sponsor's protocol ID
- 2024-BİAEK/19-40
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant privacy, confidentiality, and ethical data protection principles.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain, Upper Extremity Function, and Social Appearance Anxiety in Adults With Obstetric Brachial Plexus Palsy Who Underwent Shoulder Tendon Transfer Surgery
- ClinicalTrials.gov ID
- NCT07655271
- Acronym / sponsor ID
- 2024-BİAEK/19-40
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults With Brachial Plexus Birth Palsy | – | Diagnostic Test: Clinical Assessment BatteryAdults with obstetric brachial plexus palsy who underwent shoulder tendon transfer surgery using the Modified Hoffer technique during childhood. |
| Healthy Controls | – | Diagnostic Test: Clinical Assessment BatteryHealthy age-matched individuals without obstetric brachial plexus palsy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Assessment BatteryParticipants will undergo a standardized clinical assessment including pain, range of motion, muscle strength, functional status, social appearance anxiety, and role/activity performance measures. | Diagnostic test | Adults With Brachial Plexus Birth Palsy, Healthy Controls |
Primary outcome
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.
6 secondary outcomes
Upper Extremity Range of Motion
Time frame: Baseline
Upper Extremity Muscle Strength
Time frame: Baseline
Shoulder Pain and Disability
Time frame: Baseline
Upper Extremity Disability
Time frame: Baseline
Social Appearance Anxiety
Time frame: Baseline
Role and Activity Performance
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect participant privacy, confidentiality, and ethical data protection principles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Birth Palsy and Brachial Plexus Palsy, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity at Rest, During Activity, and at Night (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.