NCT07655271

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

Obstetric Brachial Plexus PalsyBrachial Plexus Birth PalsyAdultsLong-Term Outcomes In AdulthoodModified Hoffer TechniqueTendon TransferUpper Extremity FunctionPainRange Of MotionMuscle StrengthFunctional StatusSocial Appearance AnxietyRole Performance

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (6)

  • Upper Extremity Range of Motion

    Baseline

  • Upper Extremity Muscle Strength

    Baseline

  • Shoulder Pain and Disability

    Baseline

  • Upper Extremity Disability

    Baseline

  • Social Appearance Anxiety

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

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.

Diagnostic Test: Clinical Assessment Battery

Healthy Controls

Healthy age-matched individuals without obstetric brachial plexus palsy.

Diagnostic Test: Clinical Assessment Battery

Interventions

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

Adults With Brachial Plexus Birth PalsyHealthy Controls

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may not qualify if:

  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Istanbul, 34015, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Student

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations