Function and Form Outcomes in Patients With Facial Paralysis
1 other identifier
observational
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2018
CompletedFirst Submitted
Initial submission to the registry
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
June 5, 2019
CompletedJune 5, 2019
May 1, 2019
1.9 years
September 24, 2018
May 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
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).
First outcome measure for facial soft tissue disability = Maximum displacement (mm)
December 2019
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).
Second outcome measure for facial soft tissue disability = velocity (mm/s)
December 2019
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).
Third outcome measure for facial soft tissue disability = and asymmetry of facial soft tissue landmarks (this is a ratio measure)
December 2019
To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.
First outcome measure for group comparison = difference in maximum displacement (mm) between patients with facial disability and control group subjects
December 2019
To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.
Second outcome measure for group comparison = velocity (mm/s)
December 2019
To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.
Third outcome measure for group comparison = asymmetry of facial soft tissue landmarks (ratio)
December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
First outcome measure = average correlation across surgeons for their ratings on the House-Brackman scale and the patients' mean measures of maximum displacement
December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
Second outcome measure = average correlation across surgeons for their ratings on the House-Brackman scale and the patients' mean measures of velocity
December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
Third outcome measure = average correlation across surgeons for their ratings on the House-Brackman scale and the patients' mean measures of asymmetry of facial soft tissue landmarks
December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
Fourth outcome measure = average correlation across surgeons for their ratings on the Sunnybrook Facial Grading System and the patients' mean measures of maximum displacement
December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
Fifth outcome measure = average correlation across surgeons for their ratings on the Sunnybrook Facial Grading System and the patients' mean measures of velocity
December 2019
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
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
December 2019
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.
Measurement Tools: SP36 questionnaire, FaCE questionnaire.
December 2019
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.
Measurement Tools: PSP questionnaire.
December 2019
To correlate the patients' perceptions over time with the quantitative measures of facial disability.
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.
December 2019
Study Arms (2)
Test Group
Patients with acute, unilateral, facial paralysis (Bell's Palsy)
Control Group
A group of age- and sex-frequency matched 'normal' controls. Based on past research, gender and age are possible confounders of facial movement/function. Thus, the control group will be frequency-matched to the patient group on gender and age.
Eligibility Criteria
The subjects for this study will be adults 18 to 75 years. The subjects who are potentially eligible for participation will be identified through the participating Centers: For the patients with facial paralysis through the Facial Nerve Center (FNC) at Massachusetts Eye and Ear Infirmary (MEEI); and for the control subjects through Tufts University School of Dental Medicine (TUSDM). Subjects recruited from MEEI will attend TUSDM for testing where Dr. Trotman maintains her Facial Animation laboratory. The participating surgeon is Dr. Tessa Hadlock and she will be responsible for the clinical care of all patients.
You may qualify if:
- A diagnosis of virally triggered, acute, unilateral facial paralysis (Bell's Palsy)
- Able to attend baseline visit at Tufts within 6 weeks of onset of the condition and with an estimated potential for recovery between 6-12 weeks
- Patient interest/willingness to participate in the study
- An ability to comprehend verbal instructions; and an age range of 18 to 75 years
You may not qualify if:
- Facial movement disorders due to primary muscular dysfunction or hemifacial spasm in the absence of synkinesis
- Complaints of facial paralysis but no evidence of weakness on physical examination
- Previous facial soft tissue surgery and/or Orthognathic surgery
- Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered
- Subject interest/willingness to participate in the study
- An ability to comprehend verbal instructions
- An age range of 18 to 75 years
- Facial soft tissue surgery, orthognathic surgery, and/or facial soft tissue disorder
- Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carroll Ann Trotman
Tufts University School of Dental Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2018
First Posted
June 5, 2019
Study Start
June 20, 2016
Primary Completion
May 24, 2018
Study Completion
May 24, 2018
Last Updated
June 5, 2019
Record last verified: 2019-05