The Role of a Device to Evaluate the Neuromuscular Function in Assessing Muscle in Facial Paralysis Patients

Study Overview
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Brief Summary
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The objective of the research is to determine whether the MyotonPRO has a valid and reliable application in facial, head and neck surgery. In addition, the study aims to compare this new technology with current electromyography.

Detailed Description
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Facial paralysis has significant aesthetic, functional and psycho-social morbidity. The diagnosis and monitoring of neuromuscular recovery is limited to clinical examination, electromyography (EMG) and electroneurography (ENoG). EMG and ENoG is invasive for the patient and has practical and cost disadvantages. The MyotonPRO is a handheld device, which is pain-free and quick to use. Therefore this research is assessing MyotonPRO technology for this clinical application and may be effective at evaluating rehabilitative and surgical interventions. Phase 1 - Variation of measurements Phase 2 - Mimic muscle dysfunction assessment Phase 3 - Peri-operative Mimic and temporalis muscle assessment Phase 4 - Phase 3 including electromyography Phase 5 - Temporalis and mimic muscle assessment following facial reanimation surgery

Official Title
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The Role of MyotonPro in Assessing the Biomechanical Properties of Facial Muscles in Facial Paralysis Patients and Its Role in Monitoring Recovery Following Facial Reanimation Surgery

Conditions
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Facial Nerve Palsy

Intervention / Treatment
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* Device: MyotonPRO
* Device: non-invasive electromyography (EMG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral peripheral facial nerve palsy Mental capacity to give consent The patient is able to sit independently Exclusion Criteria: Adults who have undertaken strenuous exercise within the last twenty-four hours Adults taking prescription medication with a known effect on the mechanical properties of muscle (e.g. benzodiazepines) or receiving antispasmodic medications (e.g. botulinum A toxin) Adults with poor mobility (unable to lie prone). Adults with a body mass index (BMI) >30 kg/m2 . Muscle measurements may be inaccurate with excessive subcutaneous tissue

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MyotonPRO<br>Experimental: Measurement of biomechanical properties of mimic muscles on the ipsilateral palsy side with the healthy contralateral side ( case - control design) | Device: MyotonPRO<br>* MyotonPRO measurements of the biomechanical properties of facial mimic muscles<br>Device: non-invasive electromyography (EMG)<br>* Gold standard technique for measuring muscle<br>|
| Active Comparator: Non-invasive electromyography (EMG)<br>Comparing experimental intervention with gold standard | Device: MyotonPRO<br>* MyotonPRO measurements of the biomechanical properties of facial mimic muscles<br>Device: non-invasive electromyography (EMG)<br>* Gold standard technique for measuring muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle tone (Hz) | Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stiffness (N/m) | Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles. | 12 months |