- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06313658
Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Managing total BPBI cases is complex because surgical reconstruction must address the restoration of shoulder, elbow, and hand functions. In cases where multiple nerve root avulsions are present, prioritizing which functions to reinnervate shoulder, elbow, or hand becomes a critical decision. While attempts to restore hand function in adults with total brachial plexus lesions have yielded disappointing results, it has been shown that restoring hand function in infants with BPBI is more promising due to their enhanced neuro-regenerative capacities. Interpreting published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Various hand function scales that measure the individual joint movements or the global function of the hand and wrist have been used in the assessment of the outcomes, but none has quantitated the recovery of the intrinsic muscles of the digits or thumb. Furthermore, it is well-documented that the recovery of hand function can be a prolonged process, often extending up to eight years before reaching a plateau. The majority of the published studies have typically reported outcomes based on a minimum follow-up period of two years, which may not provide sufficient time to assess the full extent of hand function recovery.
Investigators have followed a well-defined protocol for the surgical reconstruction of total BPBI with the primary objective being restoration of hand function through reinnervation of the lower trunk followed by restoration of elbow and shoulder functions through innervation of the upper trunk. In this paper, Investigators outline the details of the surgical strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes. Furthermore, investigators explore and identify the factors that may significantly impact the recovery process.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yousif T El-Gammal
- Phone Number: +1 5023797500
- Email: yousif.elgammal@med.aun.edu.eg
Study Contact Backup
- Name: Yousif ElGammal
- Email: tyousif@kleinertkutz.com
Study Locations
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Assiut, Egypt, 71526
- Recruiting
- Assiut university hospitals
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Contact:
- Yousif T El-Gammal, MD
- Phone Number: 5023797500
- Email: yousif.elgammal@med.aun.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study will include at least 50 children:
Who underwent brachial plexus exploration and reconstruction for total OBPP. who have reached at least four years of follow-up Excluding children who had selective distal neurotization for restoration of specific functions without brachial plexus exploration or who had secondary procedures to the hand.
Description
Inclusion Criteria:
- Patients Who underwent brachial plexus exploration and reconstruction for total OBPP.
who have reached at least four years of follow-up
Exclusion Criteria:
- Excluding children who had selective distal neurotization for restoration of specific functions without brachial plexus exploration or who had secondary procedures to the hand.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Active Movement Scale (AMS)
Time Frame: 1 year
|
All patients included in the study were evaluated using the Active Movement Scale (AMS), which grades upper extremity movements from 0 to 7. Scores of 6 or 7 would be considered successful in demonstrating functionally useful movement; this is a 50% and full range of movement against gravity, respectively.Attention was focused on sex movements primarily involving hand function including wrist, finger, and thumb flexion and extension.
|
1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Al-Qattan pronation/Supination score
Time Frame: 1 year
|
Separate assessments were performed of forearm pronation/supination as described by Al-Qattan
|
1 year
|
Raimondi hand score
Time Frame: 1 year
|
Global hand function was assessed using the Raimondi scale; a score of 3 or more indicate a useful functional recovery
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Haerle M, Gilbert A. Management of complete obstetric brachial plexus lesions. J Pediatr Orthop. 2004 Mar-Apr;24(2):194-200. doi: 10.1097/00004694-200403000-00012.
- Al-Qattan MM. Assessment of the motor power in older children with obstetric brachial plexus palsy. J Hand Surg Br. 2003 Feb;28(1):46-9. doi: 10.1054/jhsb.2002.0831.
- Borschel GH, Clarke HM. Obstetrical brachial plexus palsy. Plast Reconstr Surg. 2009 Jul;124(1 Suppl):144e-155e. doi: 10.1097/PRS.0b013e3181a80798.
- Pondaag W, Malessy MJ. Recovery of hand function following nerve grafting and transfer in obstetric brachial plexus lesions. J Neurosurg. 2006 Jul;105(1 Suppl):33-40. doi: 10.3171/ped.2006.105.1.33.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Total BPBI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brachial Plexus Injury
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All India Institute of Medical Sciences, New DelhiCompletedBrachial Plexus InjuryIndia
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University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaWithdrawnBirth Related Brachial Plexus Injury | Obstetrical Brachial Plexus Palsy
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Centre Hospitalier Universitaire VaudoisWithdrawnBrachial Plexus InjurySwitzerland
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Ataturk UniversityNot yet recruitingBrachial Plexus Injury | Elasticity Imaging Techniques
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Assiut UniversityNot yet recruiting
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Siriraj HospitalLerdsin General HospitalCompleted
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University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaTerminated
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University of AlbertaRoyal Alexandra Hospital; Glenrose FoundationNot yet recruiting
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Carilion ClinicEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingBrachial Plexus InjuryUnited States
Clinical Trials on Total brachial plexus exploration and reconstruction
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The Leeds Teaching Hospitals NHS TrustUnknown
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Diskapi Yildirim Beyazit Education and Research...CompletedBrachial Plexus BlockTurkey
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Tanta UniversityCompleted
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Assam Medical CollegeCompleted
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Sohag UniversityCompleted
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University of TorontoRecruiting
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Lawson Health Research InstituteTerminated
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Minia UniversityCompleted
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JongHae KimResearch Institute of Medical Science, Daegu Catholic UniversityRecruitingOximetry | Brachial Plexus BlockKorea, Republic of
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Bezmialem Vakif UniversityRecruitingShoulder Pain | Phrenic Nerve ParalysisTurkey