Synkinesis
Conditions
Brief summary
This proposal will prospectively assess the social, physical, and emotional recognition function in participants with synkinesis. It will measure the effectiveness of neuromuscular retraining therapy to improve muscle coordination compared to chemodenervation, the more established treatment modality, in a single-blinded, randomized control trial using clinician- and patient-reported outcomes measures. The hypothesis tested is that participants undergoing neuromuscular retraining therapy will achieve greater improvement on clinical outcome measures as compared to participants receiving chemodenervation. In this clinical trial, 36 participants undergoing treatment for synkinesis will be enrolled into one of two treatment arms: chemodenervation or neuromuscular retraining therapy. Participants can expect to be on study for approximately 8 months. Participants who enroll in this mixed methods investigation will be recruited from patients of the University of Wisconsin Facial Nerve Clinic and also be enrolled in a another study for assessment \[Perception of Emotion Expression in Clinical Populations with Facial Paralysis, IRB approval 2015-0366\].
Detailed description
Facial nerve paralysis is a devastating event that in up to 30% of cases may result in chronic weakness and/or the disfiguring condition of synkinesis, a long-lasting muscle discoordination of facial movement caused by aberrant facial nerve regeneration after facial nerve paralysis. This is believed to have a detrimental effect on social interactions, mental health, and quality of life. Neuromuscular retraining therapy and ipsilateral chemodenervation into discoordinated muscles by injection (onabotulinumtoxinA/Botox, Allergan or incobotulinumtoxinA/Xeomin, Merz) are two common treatments for the abnormal muscle movements found in synkinesis. No study has compared the effectiveness of these treatment modalities for synkinesis. Retrospective data including our series at the University of Wisconsin Facial Nerve Clinic show significant benefit of retraining therapy using clinician- and patient-reported outcome measures. However, the manner in which this therapy may be optimized for use in treatment of the sequelae of facial paralysis is unclear. While literature shows beneficial improvement in outcomes with chemodenervation in prospective studies, no study has explored the effectiveness of physical therapy for synkinesis in a controlled, prospective manner. Further, the efficacy of therapy has not been shown to improve recognition and emotional information interpretation, both thought to be impaired in synkinesis. This study has 3 specific aims: AIM 1: Determine the effect of neuromuscular retraining or chemodenervation on clinician-reported and patient-reported outcomes. The primary outcome measure after four and eight months of treatment will be the clinician-reported Sunnybrook Facial Grading System (SFGS) scored on participant videos by blinded reviewers. Further, the investigators seek to measure the efficacy of treatment with existing patient-reported instruments. A correlation of clinician-reported outcome measure changes to changes in patient-reported instruments with treatment will be calculated, including the widely utilized disease specific Synkinesis Assessment Questionnaire (SAQ) and Facial Clinimetric Evaluation Scale (FaCE), and with two disease non-specific instruments, the Hospital Anxiety and Depression Scale (HADS), and Brief-Illness Perception Questionnaire (BIPQ). The efficacy of our clinical intervention will be measured with social-perceptual and mental health outcome measurement before and after treatment (AIM 3). AIM 2: Determine the social, emotional, and functional burden of synkinesis, not captured in current patient-reported outcome measures as well as effect of treatment. Qualitative interviews with individual participants collected before treatment, after four months of treatment, and after eight months of treatment will be analyzed to study the burden of disease, experience with treatment, and potential differences in both treatments. The primary outcome is to identify the domains that may be missing from existing patient-reported measures collected in AIM 1. To do this, findings to assessment domains (i.e. decreased engagement, negative mood, etc.) in the FaCE, SAQ, and the two disease non-specific instruments, HADS and BIPQ will be compared. The investigators will then evaluate their findings based on domains in Patient-Reported Outcomes Measurement Information System (PROMIS) measures, an NIH-supported collection of validated and standardized scales. AIM 3: Quantify the disruption in social functioning caused by synkinesis using innovative social-perceptual outcomes and emotion recognition tasks. Prior to treatment, participants will enroll in IRB Protocol 2015-0366 and complete a series of social functioning and mental health instruments and emotion expression recognition tasks. Results will be compared to control participants without facial disability to reveal the social-perceptual impairment attributable to synkinesis. Repetition of these tasks after four months of either treatment may show improvement in recognition and emotional information interpretation when compared to initial measurements.
Interventions
OTHERNeuromuscular Retraining Therapy (4 months)
Neuromuscular retraining is an intervention where facial therapists utilize voluntary input to access improved movement patterns in patients with synkinesis.
DRUGChemodenervation (4 months)
A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle.
OTHERNeuromuscular Retraining + Chemodenervation
Participants will receive both interventions for the last 4 months of their time on study.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Has ipsilateral synkinesis of facial muscles * It has been at least four months since their onset of peripheral facial paralysis from any cause * Ability to read and write in English
Exclusion criteria
* previous treatment with reanimation surgery (except for upper eyelid weight placement) * intolerance or contraindication to botulinum toxin injection * previous treatment for synkinesis with chemodenervation or neuromuscular retraining therapy * pregnant and/or breastfeeding women * participants with impaired decision-making capacity, including those with severe psychiatric illnesses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sunnybrook Facial Grading System (SFGS) Between Baseline and 4 Month Scoring | up to 4 months | Participants will be videotaped as part of routine care and undergo a blinded SFGS scoring. Scoring is determined by a voluntary movement score (5-items scored from 1-5 where 1 is unable to move and 5 is complete voluntary movement - total range of 5-25, multiplied by 4, where a higher score is a better outcome) minus a resting symmetry score (total of 0-4 where 0 is normal and 4 indicates some asymmetry, multiplied by 5, where a lower score is a better outcome) minus a synkinesis score (5-items scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome. Scores from baseline will be compared to those at 4 months and the change between the two will be reported. |
| Sunnybrook Facial Grading System (SFGS) at Baseline | Baseline | Participants will be videotaped as part of routine care and undergo a blinded SFGS scoring. Scoring is determined by a voluntary movement score (5-items scored from 1-5 where 1 is unable to move and 5 is complete voluntary movement - total range of 5-25, multiplied by 4, where a higher score is a better outcome) minus a resting symmetry score (total of 0-4 where 0 is normal and 4 indicates some asymmetry, multiplied by 5, where a lower score is a better outcome) minus a synkinesis score (5-items scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome. |
| Sunnybrook Facial Grading System (SFGS) at 4 Months | 4 months | Participants will be videotaped as part of routine care and undergo a blinded SFGS scoring. Scoring is determined by a voluntary movement score (5-items scored from 1-5 where 1 is unable to move and 5 is complete voluntary movement - total range of 5-25, multiplied by 4, where a higher score is a better outcome) minus a resting symmetry score (total of 0-4 where 0 is normal and 4 indicates some asymmetry, multiplied by 5, where a lower score is a better outcome) minus a synkinesis score (5-items scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome. |
| Sunnybrook Facial Grading System (SFGS) at 8 Months | 8 months | Participants will be videotaped as part of routine care and undergo a blinded SFGS scoring. Scoring is determined by a voluntary movement score (5-items scored from 1-5 where 1 is unable to move and 5 is complete voluntary movement - total range of 5-25, multiplied by 4, where a higher score is a better outcome) minus a resting symmetry score (total of 0-4 where 0 is normal and 4 indicates some asymmetry, multiplied by 5, where a lower score is a better outcome) minus a synkinesis score (5-items scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Facial Clinimetric Evaluation Scale (FaCE) at 4 Months | 4 months | The FaCE scale is 15-item self-report survey to assess the symptoms of facial paralysis in the past week. The total possible range of scores is 15-100 where the higher the score, the lesser the symptoms. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Facial Clinimetric Evaluation Scale (FaCE) at 8 Months | up to 8 months | The FaCE scale is 15-item self-report survey to assess the symptoms of facial paralysis in the past week. The total possible range of scores is 15-100 where the higher the score, the lesser the symptoms. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Hospital Anxiety and Depression Scale (HADS) at Baseline | Baseline | The HADS instrument measures anxiety and depressive tendency. 7-items are scored for depression with a total score of 0-21 where the higher the score, the more symptoms of depression. 7-items are scored for anxiety with a total score of 0-21 where the higher the score, the more symptoms of anxiety. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Hospital Anxiety and Depression Scale (HADS) at 4 Months | 4 months | The HADS instrument measures anxiety and depressive tendency. 7-items are scored for depression with a total score of 0-21 where the higher the score, the more symptoms of depression. 7-items are scored for anxiety with a total score of 0-21 where the higher the score, the more symptoms of anxiety. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Hospital Anxiety and Depression Scale (HADS) at 8 Months | 8 months | The HADS instrument measures anxiety and depressive tendency. 7-items are scored for depression with a total score of 0-21 where the higher the score, the more symptoms of depression. 7-items are scored for anxiety with a total score of 0-21 where the higher the score, the more symptoms of anxiety. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Facial Clinimetric Evaluation Scale (FaCE) at Baseline | Baseline | The FaCE scale is 15-item self-report survey to assess the symptoms of facial paralysis in the past week. The total possible range of scores is 15-100 where the higher the score, the lesser the symptoms. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Brief-Illness Perception Questionnaire (BIPQ) at 4 Months | 4 months | The BIPQ is a 9-item questionnaire, where the first 8-items are scored from 0-10. To determine a composite score, items 3, 4, and 7 should be reversed scored and added to 1, 2, 5, 6, and 8 (total range of possible scores from 0-80). The higher the score the more threatening the illness is perceived to be. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Brief-Illness Perception Questionnaire (BIPQ) at 8 Months | up to 8 months | The BIPQ is a 9-item questionnaire, where the first 8-items are scored from 0-10. To determine a composite score, items 3, 4, and 7 should be reversed scored and added to 1, 2, 5, 6, and 8 (total range of possible scores from 0-80). The higher the score the more threatening the illness is perceived to be. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Pre-Treatment Qualitative Interviews | up to 8 months | Qualitative analysis will proceed concurrently with data collection to allow identified themes to be explored in subsequent interviews. In qualitative research this involves both coding the written transcripts and then modeling the coded data. All team members will analyze the data and look for themes and trends that are emergent from the data. For the pre-treatment interviews, Conventional Content Analysis will be employed to obtain direct information from study participants without imposing preconceived categories or theoretical perspectives. |
| Post-Treatment Qualitative Interviews | up to 4 months | Qualitative analysis will proceed concurrently with data collection to allow identified themes to be explored in subsequent interviews. In qualitative research this involves both coding the written transcripts and then modeling the coded data. All team members will analyze the data and look for themes and trends that are emergent from the data. For post-treatment interviews, directed content analysis will be employed as findings from pre-treatment interviews will guide analysis of post-treatment interviews while capturing emergent themes that come up in the data. |
| Brief-Illness Perception Questionnaire (BIPQ) at Baseline | Baseline | The BIPQ is a 9-item questionnaire, where the first 8-items are scored from 0-10. To determine a composite score, items 3, 4, and 7 should be reversed scored and added to 1, 2, 5, 6, and 8 (total range of possible scores from 0-80). The higher the score the more threatening the illness is perceived to be. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Synkinesis Assessment Questionnaire (SAQ) at Baseline | Baseline | The SAQ is a 9-item questionnaire where each item is scored on a scale from 1-5, 1 is seldom or not at all, and 5 is all of the time, or severely. A higher score indicates a worse outcome. The total range in possible scores is 9-100 (summate scores for questions 1-9/45x100 = SAQ total score) with higher scores indicating more severe facial paralysis symptoms. SAQ scores will be collected as part of routine care throughout the study. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Synkinesis Assessment Questionnaire (SAQ) at 4 Months | 4 months | The SAQ is a 9-item questionnaire where each item is scored on a scale from 1-5, 1 is seldom or not at all, and 5 is all of the time, or severely. A higher score indicates a worse outcome. The total range in possible scores is 9-100 (summate scores for questions 1-9/45x100 = SAQ total score) with higher scores indicating more severe facial paralysis symptoms. SAQ scores will be collected as part of routine care throughout the study. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
| Synkinesis Assessment Questionnaire (SAQ) at 8 Months | 8 months | The SAQ is a 9-item questionnaire where each item is scored on a scale from 1-5, 1 is seldom or not at all, and 5 is all of the time, or severely. A higher score indicates a worse outcome. The total range in possible scores is 9-100 (summate scores for questions 1-9/45x100 = SAQ total score) with higher scores indicating more severe facial paralysis symptoms. SAQ scores will be collected as part of routine care throughout the study. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neuromuscular Retraining Therapy Neuromuscular retraining therapy alone for four months, with botulinum toxin injection added during an additional four month period.
Neuromuscular Retraining Therapy (4 months): Neuromuscular retraining is an intervention where facial therapists utilize voluntary input to access improved movement patterns in patients with synkinesis.
Neuromuscular Retraining + Chemodenervation: Participants will receive both interventions for the last 4 months of their time on study. | 7 |
| Chemodenervation Ipsilateral chemodenervation with botulinum toxin injections alone for four months (onabotulinumtoxinA/Botox, Allergan or incobotulinumtoxinA/Xeomin, Merz), with neuromuscular retraining therapy added for an additional four months.
Chemodenervation (4 months): A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle.
Neuromuscular Retraining + Chemodenervation: Participants will receive both interventions for the last 4 months of their time on study. | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Chemodenervation | Total | Neuromuscular Retraining Therapy |
|---|---|---|---|
| Age, Continuous | 49.88 years | 50.67 years | 51.57 years |
| Cause of Facial Palsy Bell's | 6 Participants | 12 Participants | 6 Participants |
| Cause of Facial Palsy Other | 1 Participants | 1 Participants | 0 Participants |
| Cause of Facial Palsy Ramsay-Hunt | 1 Participants | 1 Participants | 0 Participants |
| Cause of Facial Palsy Trauma | 0 Participants | 1 Participants | 1 Participants |
| Diagnosis Facial nerve paralysis: mixed with Synkinesis | 7 Participants | 14 Participants | 7 Participants |
| Diagnosis Facial nerve paralysis: Synkinesis only | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 15 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Laterality Left | 3 Participants | 5 Participants | 2 Participants |
| Laterality Right | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 13 Participants | 6 Participants |
| Region of Enrollment United States | 8 participants | 15 participants | 7 participants |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
Primary
Change in Sunnybrook Facial Grading System (SFGS) Between Baseline and 4 Month Scoring
Participants will be videotaped as part of routine care and undergo a blinded SFGS scoring. Scoring is determined by a voluntary movement score (5-items scored from 1-5 where 1 is unable to move and 5 is complete voluntary movement - total range of 5-25, multiplied by 4, where a higher score is a better outcome) minus a resting symmetry score (total of 0-4 where 0 is normal and 4 indicates some asymmetry, multiplied by 5, where a lower score is a better outcome) minus a synkinesis score (5-items scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome. Scores from baseline will be compared to those at 4 months and the change between the two will be reported.
Time frame: up to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Change in Sunnybrook Facial Grading System (SFGS) Between Baseline and 4 Month Scoring | 0.29 score on a scale | Standard Deviation 4.72 |
| Chemodenervation | Change in Sunnybrook Facial Grading System (SFGS) Between Baseline and 4 Month Scoring | 5.86 score on a scale | Standard Deviation 3.72 |
Primary
Sunnybrook Facial Grading System (SFGS) at 4 Months
Participants will be videotaped as part of routine care and undergo a blinded SFGS scoring. Scoring is determined by a voluntary movement score (5-items scored from 1-5 where 1 is unable to move and 5 is complete voluntary movement - total range of 5-25, multiplied by 4, where a higher score is a better outcome) minus a resting symmetry score (total of 0-4 where 0 is normal and 4 indicates some asymmetry, multiplied by 5, where a lower score is a better outcome) minus a synkinesis score (5-items scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Sunnybrook Facial Grading System (SFGS) at 4 Months | 66.00 score on a scale | Standard Deviation 6.98 |
| Chemodenervation | Sunnybrook Facial Grading System (SFGS) at 4 Months | 60.14 score on a scale | Standard Deviation 10.9 |
Primary
Sunnybrook Facial Grading System (SFGS) at 8 Months
Participants will be videotaped as part of routine care and undergo a blinded SFGS scoring. Scoring is determined by a voluntary movement score (5-items scored from 1-5 where 1 is unable to move and 5 is complete voluntary movement - total range of 5-25, multiplied by 4, where a higher score is a better outcome) minus a resting symmetry score (total of 0-4 where 0 is normal and 4 indicates some asymmetry, multiplied by 5, where a lower score is a better outcome) minus a synkinesis score (5-items scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome.
Time frame: 8 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Sunnybrook Facial Grading System (SFGS) at 8 Months | 73.00 score on a scale | Standard Deviation 8.89 |
| Chemodenervation | Sunnybrook Facial Grading System (SFGS) at 8 Months | 60.25 score on a scale | Standard Deviation 4.03 |
Primary
Sunnybrook Facial Grading System (SFGS) at Baseline
Participants will be videotaped as part of routine care and undergo a blinded SFGS scoring. Scoring is determined by a voluntary movement score (5-items scored from 1-5 where 1 is unable to move and 5 is complete voluntary movement - total range of 5-25, multiplied by 4, where a higher score is a better outcome) minus a resting symmetry score (total of 0-4 where 0 is normal and 4 indicates some asymmetry, multiplied by 5, where a lower score is a better outcome) minus a synkinesis score (5-items scored from 0-3 where 0 is none and 3 is severe, a lower score is a better outcome). Total possible range of scores is 20-100, with a higher score being a better outcome.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Sunnybrook Facial Grading System (SFGS) at Baseline | 65.71 score on a scale | Standard Deviation 9.3 |
| Chemodenervation | Sunnybrook Facial Grading System (SFGS) at Baseline | 54.29 score on a scale | Standard Deviation 13.21 |
Secondary
Brief-Illness Perception Questionnaire (BIPQ) at 4 Months
The BIPQ is a 9-item questionnaire, where the first 8-items are scored from 0-10. To determine a composite score, items 3, 4, and 7 should be reversed scored and added to 1, 2, 5, 6, and 8 (total range of possible scores from 0-80). The higher the score the more threatening the illness is perceived to be. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: 4 months
Population: 2 participants in the Chemodenervation arm did not progress to 4 months on study and therefore were not analyzed for this measure at this timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Brief-Illness Perception Questionnaire (BIPQ) at 4 Months | 31.71 score on a scale | Standard Deviation 7.16 |
| Chemodenervation | Brief-Illness Perception Questionnaire (BIPQ) at 4 Months | 45.40 score on a scale | Standard Deviation 11.17 |
Secondary
Brief-Illness Perception Questionnaire (BIPQ) at 8 Months
The BIPQ is a 9-item questionnaire, where the first 8-items are scored from 0-10. To determine a composite score, items 3, 4, and 7 should be reversed scored and added to 1, 2, 5, 6, and 8 (total range of possible scores from 0-80). The higher the score the more threatening the illness is perceived to be. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: up to 8 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Brief-Illness Perception Questionnaire (BIPQ) at 8 Months | 32.57 score on a scale | Standard Deviation 8.52 |
| Chemodenervation | Brief-Illness Perception Questionnaire (BIPQ) at 8 Months | 42.17 score on a scale | Standard Deviation 7.52 |
Secondary
Brief-Illness Perception Questionnaire (BIPQ) at Baseline
The BIPQ is a 9-item questionnaire, where the first 8-items are scored from 0-10. To determine a composite score, items 3, 4, and 7 should be reversed scored and added to 1, 2, 5, 6, and 8 (total range of possible scores from 0-80). The higher the score the more threatening the illness is perceived to be. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Brief-Illness Perception Questionnaire (BIPQ) at Baseline | 40.00 score on a scale | Standard Deviation 8.31 |
| Chemodenervation | Brief-Illness Perception Questionnaire (BIPQ) at Baseline | 51.43 score on a scale | Standard Deviation 6.45 |
Secondary
Facial Clinimetric Evaluation Scale (FaCE) at 4 Months
The FaCE scale is 15-item self-report survey to assess the symptoms of facial paralysis in the past week. The total possible range of scores is 15-100 where the higher the score, the lesser the symptoms. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Facial Clinimetric Evaluation Scale (FaCE) at 4 Months | 63.10 score on a scale | Standard Deviation 13.28 |
| Chemodenervation | Facial Clinimetric Evaluation Scale (FaCE) at 4 Months | 45.95 score on a scale | Standard Deviation 21.45 |
Secondary
Facial Clinimetric Evaluation Scale (FaCE) at 8 Months
The FaCE scale is 15-item self-report survey to assess the symptoms of facial paralysis in the past week. The total possible range of scores is 15-100 where the higher the score, the lesser the symptoms. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: up to 8 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Facial Clinimetric Evaluation Scale (FaCE) at 8 Months | 71.67 score on a scale | Standard Deviation 9.28 |
| Chemodenervation | Facial Clinimetric Evaluation Scale (FaCE) at 8 Months | 61.67 score on a scale | Standard Deviation 11.63 |
Secondary
Facial Clinimetric Evaluation Scale (FaCE) at Baseline
The FaCE scale is 15-item self-report survey to assess the symptoms of facial paralysis in the past week. The total possible range of scores is 15-100 where the higher the score, the lesser the symptoms. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Facial Clinimetric Evaluation Scale (FaCE) at Baseline | 56.43 score on a scale | Standard Deviation 15.85 |
| Chemodenervation | Facial Clinimetric Evaluation Scale (FaCE) at Baseline | 42.14 score on a scale | Standard Deviation 25.8 |
Secondary
Hospital Anxiety and Depression Scale (HADS) at 4 Months
The HADS instrument measures anxiety and depressive tendency. 7-items are scored for depression with a total score of 0-21 where the higher the score, the more symptoms of depression. 7-items are scored for anxiety with a total score of 0-21 where the higher the score, the more symptoms of anxiety. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: 4 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neuromuscular Retraining Therapy | Hospital Anxiety and Depression Scale (HADS) at 4 Months | Anxiety | 6.57 score on a scale | Standard Deviation 3.26 |
| Neuromuscular Retraining Therapy | Hospital Anxiety and Depression Scale (HADS) at 4 Months | Depression | 4.14 score on a scale | Standard Deviation 2.34 |
| Chemodenervation | Hospital Anxiety and Depression Scale (HADS) at 4 Months | Anxiety | 8.00 score on a scale | Standard Deviation 3.74 |
| Chemodenervation | Hospital Anxiety and Depression Scale (HADS) at 4 Months | Depression | 5.60 score on a scale | Standard Deviation 5.13 |
Secondary
Hospital Anxiety and Depression Scale (HADS) at 8 Months
The HADS instrument measures anxiety and depressive tendency. 7-items are scored for depression with a total score of 0-21 where the higher the score, the more symptoms of depression. 7-items are scored for anxiety with a total score of 0-21 where the higher the score, the more symptoms of anxiety. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: 8 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neuromuscular Retraining Therapy | Hospital Anxiety and Depression Scale (HADS) at 8 Months | Depression | 5.50 score on a scale | Standard Deviation 2.35 |
| Neuromuscular Retraining Therapy | Hospital Anxiety and Depression Scale (HADS) at 8 Months | Anxiety | 6.67 score on a scale | Standard Deviation 2.88 |
| Chemodenervation | Hospital Anxiety and Depression Scale (HADS) at 8 Months | Anxiety | 7.50 score on a scale | Standard Deviation 3.67 |
| Chemodenervation | Hospital Anxiety and Depression Scale (HADS) at 8 Months | Depression | 2.67 score on a scale | Standard Deviation 1.75 |
Secondary
Hospital Anxiety and Depression Scale (HADS) at Baseline
The HADS instrument measures anxiety and depressive tendency. 7-items are scored for depression with a total score of 0-21 where the higher the score, the more symptoms of depression. 7-items are scored for anxiety with a total score of 0-21 where the higher the score, the more symptoms of anxiety. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neuromuscular Retraining Therapy | Hospital Anxiety and Depression Scale (HADS) at Baseline | Anxiety | 6.14 score on a scale | Standard Deviation 4.3 |
| Neuromuscular Retraining Therapy | Hospital Anxiety and Depression Scale (HADS) at Baseline | Depression | 5.71 score on a scale | Standard Deviation 3.15 |
| Chemodenervation | Hospital Anxiety and Depression Scale (HADS) at Baseline | Anxiety | 10.29 score on a scale | Standard Deviation 4.15 |
| Chemodenervation | Hospital Anxiety and Depression Scale (HADS) at Baseline | Depression | 7.00 score on a scale | Standard Deviation 4.47 |
Secondary
Post-Treatment Qualitative Interviews
Qualitative analysis will proceed concurrently with data collection to allow identified themes to be explored in subsequent interviews. In qualitative research this involves both coding the written transcripts and then modeling the coded data. All team members will analyze the data and look for themes and trends that are emergent from the data. For post-treatment interviews, directed content analysis will be employed as findings from pre-treatment interviews will guide analysis of post-treatment interviews while capturing emergent themes that come up in the data.
Time frame: up to 4 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Other mouth control | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tension in forehead | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Enunciation | Stayed the same | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tension in forehead | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Sounds in ear | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tension in forehead | Not discussed | 6 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Smile | Stayed the same | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in cheek | Improved | 3 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Sounds in ear | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Overall facial tightness | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in cheek | Stayed the same | 3 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Other mouth control | Not discussed | 2 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in cheek | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Sounds in ear | Not discussed | 6 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye closing too much (triggered) | Not discussed | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Pain from tightness/spasms | Not discussed | 4 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Overall facial tightness | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye closing too much (at rest) | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in mouth | Stayed the same | 3 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Control while eating/drinking | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in mouth | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye closing too much (at rest) | Got worse | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in mouth | Not discussed | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Smile | Not discussed | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in neck | Improved | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye closing too much (at rest) | Not discussed | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in neck | Stayed the same | 4 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Other mouth control | Improved | 3 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in neck | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye watering | Improved | 5 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in neck | Not discussed | 3 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Overall facial tightness | Not discussed | 3 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Pain from tightness/spasms | Improved | 3 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye watering | Stayed the same | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Pain from tightness/spasms | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Control over eye trigger | Improved | 7 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Pain from tightness/spasms | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye watering | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Smile | Improved | 6 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Control while eating/drinking | Improved | 6 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Control while eating/drinking | Not discussed | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye watering | Not discussed | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Enunciation | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Control over eye trigger | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Enunciation | Not discussed | 5 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Control while eating/drinking | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | General control of muscles | Improved | 4 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in mouth | Improved | 4 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception of Impact on Life | Improved | 2 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | General control of muscles | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception of Impact on Life | Stayed the same | 4 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Control over eye trigger | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception of Impact on Life | Got worse | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | General control of muscles | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception of Impact on Life | Not discussed | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Other mouth control | Stayed the same | 2 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception on Symptom Control | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception on Symptom Control | Improved | 6 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | General control of muscles | Not discussed | 3 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Control over eye trigger | Not discussed | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception on Symptom Control | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Facial asymmetry | Improved | 4 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception on Symptom Control | Not discussed | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Disease Understanding | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Enunciation | Improved | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Concern about the disease | Improved | 5 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Facial asymmetry | Stayed the same | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Concern about the disease | Stayed the same | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye closing too much (triggered) | Improved | 6 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Concern about the disease | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Facial asymmetry | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Concern about the disease | Not discussed | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye closing too much (at rest) | Improved | 6 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Disease Understanding | Improved | 7 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Facial asymmetry | Not discussed | 3 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye closing too much (triggered) | Stayed the same | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Disease Understanding | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Sounds in ear | Improved | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Disease Understanding | Not discussed | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Overall facial tightness | Improved | 4 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception of Emotional Impact | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception of Emotional Impact | Improved | 2 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Smile | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception of Emotional Impact | Stayed the same | 5 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Eye closing too much (triggered) | Got worse | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tension in forehead | Improved | 1 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Perception of Emotional Impact | Not discussed | 0 Participants |
| Neuromuscular Retraining Therapy | Post-Treatment Qualitative Interviews | Tightness in cheek | Not discussed | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception of Emotional Impact | Not discussed | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in cheek | Not discussed | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Smile | Stayed the same | 3 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Smile | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Smile | Not discussed | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Enunciation | Improved | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Enunciation | Stayed the same | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Control while eating/drinking | Got worse | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Other mouth control | Improved | 5 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Control while eating/drinking | Not discussed | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Other mouth control | Stayed the same | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Other mouth control | Got worse | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Sounds in ear | Not discussed | 6 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye closing too much (at rest) | Improved | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Other mouth control | Not discussed | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Overall facial tightness | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Control over eye trigger | Improved | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Control over eye trigger | Stayed the same | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Control over eye trigger | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Control over eye trigger | Not discussed | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye closing too much (triggered) | Improved | 5 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye closing too much (triggered) | Stayed the same | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye closing too much (triggered) | Got worse | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Sounds in ear | Improved | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Sounds in ear | Stayed the same | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Sounds in ear | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye closing too much (triggered) | Not discussed | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye closing too much (at rest) | Stayed the same | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye closing too much (at rest) | Got worse | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye closing too much (at rest) | Not discussed | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye watering | Improved | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye watering | Stayed the same | 3 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye watering | Got worse | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Eye watering | Not discussed | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | General control of muscles | Improved | 3 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | General control of muscles | Stayed the same | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | General control of muscles | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | General control of muscles | Not discussed | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Facial asymmetry | Improved | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Facial asymmetry | Stayed the same | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Facial asymmetry | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Facial asymmetry | Not discussed | 3 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Overall facial tightness | Improved | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Overall facial tightness | Not discussed | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tension in forehead | Improved | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tension in forehead | Stayed the same | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tension in forehead | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tension in forehead | Not discussed | 6 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in cheek | Improved | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in cheek | Stayed the same | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in cheek | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Overall facial tightness | Stayed the same | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Pain from tightness/spasms | Not discussed | 3 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in mouth | Improved | 3 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in mouth | Stayed the same | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in mouth | Got worse | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in mouth | Not discussed | 3 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in neck | Improved | 3 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in neck | Stayed the same | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in neck | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Tightness in neck | Not discussed | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Pain from tightness/spasms | Improved | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Pain from tightness/spasms | Stayed the same | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Pain from tightness/spasms | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Control while eating/drinking | Improved | 6 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Smile | Improved | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Enunciation | Got worse | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Enunciation | Not discussed | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Control while eating/drinking | Stayed the same | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception of Impact on Life | Improved | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception of Impact on Life | Stayed the same | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception of Impact on Life | Got worse | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception of Impact on Life | Not discussed | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception on Symptom Control | Improved | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception on Symptom Control | Stayed the same | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception on Symptom Control | Got worse | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception on Symptom Control | Not discussed | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Concern about the disease | Improved | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Concern about the disease | Stayed the same | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Concern about the disease | Got worse | 1 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Concern about the disease | Not discussed | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Disease Understanding | Improved | 4 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Disease Understanding | Stayed the same | 3 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Disease Understanding | Got worse | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Disease Understanding | Not discussed | 0 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception of Emotional Impact | Improved | 2 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception of Emotional Impact | Stayed the same | 5 Participants |
| Chemodenervation | Post-Treatment Qualitative Interviews | Perception of Emotional Impact | Got worse | 0 Participants |
Secondary
Pre-Treatment Qualitative Interviews
Qualitative analysis will proceed concurrently with data collection to allow identified themes to be explored in subsequent interviews. In qualitative research this involves both coding the written transcripts and then modeling the coded data. All team members will analyze the data and look for themes and trends that are emergent from the data. For the pre-treatment interviews, Conventional Content Analysis will be employed to obtain direct information from study participants without imposing preconceived categories or theoretical perspectives.
Time frame: up to 8 months
Population: Data were not collected.
Secondary
Synkinesis Assessment Questionnaire (SAQ) at 4 Months
The SAQ is a 9-item questionnaire where each item is scored on a scale from 1-5, 1 is seldom or not at all, and 5 is all of the time, or severely. A higher score indicates a worse outcome. The total range in possible scores is 9-100 (summate scores for questions 1-9/45x100 = SAQ total score) with higher scores indicating more severe facial paralysis symptoms. SAQ scores will be collected as part of routine care throughout the study. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Synkinesis Assessment Questionnaire (SAQ) at 4 Months | 64.07 score on a scale | Standard Deviation 15.55 |
| Chemodenervation | Synkinesis Assessment Questionnaire (SAQ) at 4 Months | 63.18 score on a scale | Standard Deviation 16.22 |
Secondary
Synkinesis Assessment Questionnaire (SAQ) at 8 Months
The SAQ is a 9-item questionnaire where each item is scored on a scale from 1-5, 1 is seldom or not at all, and 5 is all of the time, or severely. A higher score indicates a worse outcome. The total range in possible scores is 9-100 (summate scores for questions 1-9/45x100 = SAQ total score) with higher scores indicating more severe facial paralysis symptoms. SAQ scores will be collected as part of routine care throughout the study. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: 8 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Synkinesis Assessment Questionnaire (SAQ) at 8 Months | 55.55 score on a scale | Standard Deviation 16.02 |
| Chemodenervation | Synkinesis Assessment Questionnaire (SAQ) at 8 Months | 56.67 score on a scale | Standard Deviation 26.26 |
Secondary
Synkinesis Assessment Questionnaire (SAQ) at Baseline
The SAQ is a 9-item questionnaire where each item is scored on a scale from 1-5, 1 is seldom or not at all, and 5 is all of the time, or severely. A higher score indicates a worse outcome. The total range in possible scores is 9-100 (summate scores for questions 1-9/45x100 = SAQ total score) with higher scores indicating more severe facial paralysis symptoms. SAQ scores will be collected as part of routine care throughout the study. Scores will be reported for baseline, 4 months (mid-study), and 8 months (end of study).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Retraining Therapy | Synkinesis Assessment Questionnaire (SAQ) at Baseline | 54.92 score on a scale | Standard Deviation 11.67 |
| Chemodenervation | Synkinesis Assessment Questionnaire (SAQ) at Baseline | 52.70 score on a scale | Standard Deviation 23.68 |