An observational study in Obstetric Brachial Plexus Injury, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Istanbul University - Cerrahpasa · Observational
Obstetric brachial plexus palsy (OBPP) arises from perinatal injury to the brachial plexus, resulting in varying degrees of motor and sensory impairment in the upper extremity. While existing assessment instruments primarily target unilateral limb function, they frequently overlook bimanual capabilities, which are essential for functional independence. This study aims to investigate the utility of the Duruöz Hand Index (DHI) as a reliable, valid, and practical instrument for evaluating functional limitations in individuals with OBPP. A cohort of 21 pediatric patients (aged 6-18 years) with OBPP was recruited from a tertiary university hospital in Turkey. Functional assessment included grip and pinch strength, range of motion, and upper extremity performance, measured using the Modified Mallet Classification, Brachial Plexus Outcome Measure (BPOM), Pediatric Outcomes Data Collection Instrument (PODCI), and DHI
Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.
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The study cohort consisted of patients who were under regular follow-up at our tertiary care hospital and met the inclusion criteria.
Exclusion Criteria:
The study included twenty-one children aged 6 to 18 years, all diagnosed with OBPP, who were followed up at the Physical Medicine and Rehabilitation outpatient clinic of a tertiary university hospital in Turkey. The exclusion criteria were a history of trauma or surgery affecting the function of the affected extremity (other than OBPP), the presence of systemic diseases that could impair hand function (such as polyneuropathy), and cognitive impairments that could affect comprehension.
Validity and reliability
The primary outcome measure was the Duruöz Hand Index (DHI), which was investigated to determine whether it can adequately capture impairments in bimanual function during daily activities and provide a comprehensive assessment of functional disability in patients with OBPP. To evaluate the validity of the DHI, its correlations with established outcome measures-including the Modified Mallet Classification, Brachial Plexus Outcome Measure (BPOM), Pediatric Outcomes Data Collection Instrument (PODCI), as well as grip and pinch strength and range of motion-were examined. Reliability was assessed through internal consistency using Cronbach's alpha.
Time frame: At baseline
Plan to share: Yes — The individual participant data (IPD) collected during this study will be shared in an anonymized format. All identifying information will be removed to ensure participant confidentiality, and only de-identified datasets underlying the study results will be made available to qualified researchers upon request
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Istanbul University - Cerrahpasa