Function and Form Outcomes in Patients With Facial Paralysis

Completed

• Conditions: Facial Paralysis; Bell Palsy

• Registration Number: NCT03974763
• Lead Sponsor: Tufts University

Brief Summary

This study will be unique for the rehabilitation of patients with facial paralysis in that the focus is to generate novel 3D facial soft tissue measures to characterize the condition and temporal changes, and on the generation of future testable hypotheses to optimize surgical interventions and outcomes. In addition, the investigators will extend our previous work, beyond the facial circumoral and lip areas/zones, to characterize additional facial zones specific for facial paralysis.

The approach for facial mapping of soft tissue movement, when validated through this proposed study, can be used for both surgical planning and to support the development and training of implantable facial pacing devices. Mapping both normal facial movements and movements of patients with unilateral facial paralysis are vital to describe the temporal and spatial course of the recovery process. Ultimately, this information can be used to inform clinicians on the precise placement of these devices and the signal strength needed to facilitate movements in the required 'paralyzed' facial zones until the recovery process has been completed.

Detailed Description

Patients with facial paralysis have an obvious facial disability. The resultant facial disability includes facial disfigurement and impairment in soft tissue movements, particularly in facial expressive behaviors. These negative physical sequelae not only impact facial esthetics and function, but also patients' social and emotional quality of life. Treatments range from non-surgical interventions and facial reanimation surgery to new implantable facial pacing devices that would potentially initiate artificial movement on the paralyzed side of the face. Traditionally, surgeons' plan treatment based on isolated measurements made from 2D photographs and subjective grading of the patient's face, both of which are limited in scope and dimension. Our research group has demonstrated the utility of a novel 3D dynamic and static quantitative (objective) measures for the evaluation of facial soft tissue function. The measures are objective and quantitative, and they provide a more precise diagnosis of facial soft tissue disability and evaluation of surgical outcomes. The main goal of this prospective, observational study is to determine the applicability of these novel 3D dynamic and static measures for quantification and measurement of impairment and disfigurement, as well as change over time, in patients with facial paralysis. The global hypothesis is that the use of the measures will provide a more comprehensive analysis of the severity of facial paralysis and the changes over time (recovery) when compared with current assessment methods.

Study Timeline

• Study Start: 2016-06-20
• Primary Completion: 2018-05-24
• Study Completion: 2018-05-24
• Study First Submitted: 2018-09-24
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-31
• Last Update Submitted: 2019-05-31
• Study First Posted: 2019-06-05
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.	December 2019	Sixth outcome measure = average correlation across surgeons for their ratings on the Sunnybrook Facial Grading System and the patients' mean measures of asymmetry of facial soft tissue landmarks
To assess perceptions of quality of life over time in patients with acute, unilateral, flaccid facial paralysis and to compare these perceptions with those of control subjects.	December 2019	Measurement Tools: PSP questionnaire.
To correlate the patients' perceptions over time with the quantitative measures of facial disability.	December 2019	Relationship between the quantitative measurements of facial movement with the quality of life and patient perception measures. This relationship will be measured using the linear mixed effects model or generalized estimating equations as appropriate.
To quantitatively evaluate the range of facial soft tissue disability in patients with acute, unilateral, flaccid facial paralysis and track the changes over time (3-month recovery period).	December 2019	Third outcome measure for facial soft tissue disability = and asymmetry of facial soft tissue landmarks (this is a ratio measure)
To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.	December 2019	Third outcome measure for group comparison = asymmetry of facial soft tissue landmarks (ratio)
To assess perceptions of facial appearance over time in patients with acute, unilateral, flaccid facial paralysis and to compare these perceptions with those of control subjects.	December 2019	Measurement Tools: SP36 questionnaire, FaCE questionnaire.

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States