Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538103
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Eye Soft Surgery for Facial Sinkynesis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combining Early Lower Eyelid Surgery With Neuromuscular Retraining for Synkinesis Prevention After Facial Palsy
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Facial synkinesis FS is a distressing sequela of facial palsy FP characterized by involuntary simultaneous movements of facial muscles occurring during voluntary facial expressions Treatment of synkinesis is challenging and preventive methods are needed
This study evaluates the efficacy of physical facial nerve rehabilitation PFNR therapy alone versus PNFR with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis
25 outpatients are randomized to receive either PFNR alone neuromuscular retraining and Kabat proprioceptive neuromuscular facilitation or PNFR and early 90 days after FP onset eyelid surgery involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion Comprehensive otolaryngological assessments and Magnetic Resonance Imaging MRI will be conducted Synkinesis progression was measured using Another Disease Scale ADS at baseline 3 months 6 months 12 months and 24-months post-treatment The data were analyzed with ANOVA t-test Chi-Square analyses
This study evaluates the efficacy of physical facial nerve rehabilitation PFNR therapy alone versus PNFR with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis
25 outpatients are randomized to receive either PFNR alone neuromuscular retraining and Kabat proprioceptive neuromuscular facilitation or PNFR and early 90 days after FP onset eyelid surgery involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion Comprehensive otolaryngological assessments and Magnetic Resonance Imaging MRI will be conducted Synkinesis progression was measured using Another Disease Scale ADS at baseline 3 months 6 months 12 months and 24-months post-treatment The data were analyzed with ANOVA t-test Chi-Square analyses
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None