NCT07151053

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

August 27, 2025

Last Update Submit

August 27, 2025

Conditions

Keywords

Brachial plexusDuruöz Hand Index

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline

Study Arms (1)

Grup 1

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.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study cohort consisted of patients who were under regular follow-up at our tertiary care hospital and met the inclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • Cognitive impairments that could affect comprehension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (3)

  • Misirlioglu TO, Unalan H, Karamehmetoglu SS. Validation of Duruoz Hand Index in patients with tetraplegia. J Hand Ther. 2016 Jul-Sep;29(3):269-74. doi: 10.1016/j.jht.2015.10.001. Epub 2015 Oct 22.

    PMID: 26541579BACKGROUND
  • Duruoz MT, Poiraudeau S, Fermanian J, Menkes CJ, Amor B, Dougados M, Revel M. Development and validation of a rheumatoid hand functional disability scale that assesses functional handicap. J Rheumatol. 1996 Jul;23(7):1167-72.

    PMID: 8823687BACKGROUND
  • O'Berry P, Brown M, Phillips L, Evans SH. Obstetrical Brachial Plexus Palsy. Curr Probl Pediatr Adolesc Health Care. 2017 Jul;47(7):151-155. doi: 10.1016/j.cppeds.2017.06.003. Epub 2017 Jul 12.

    PMID: 28709767BACKGROUND

Study Officials

  • Tuğçe Özekli Mısırlıoğlu, Prof., PM&R

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical medicine and rehabilitation specialist

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 2, 2025

Study Start

March 5, 2020

Primary Completion

April 1, 2022

Study Completion

July 15, 2022

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
De-identified individual participant data (IPD) and supporting documents will be available starting from the date of publication of the main study results and will remain accessible for 5 years.
Access Criteria
IPD and supporting information will be accessible to qualified researchers for academic or scientific purposes. Access requests can be submitted via email to the corresponding author, and data will be shared after approval and signing of a data use agreement to ensure confidentiality and ethical use.

Locations