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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyotonPRO | Experimental | Experimental: Measurement of biomechanical properties of mimic muscles on the ipsilateral palsy side with the healthy contralateral side ( case - control design) |
|
| Non-invasive electromyography (EMG) | Active Comparator | Comparing experimental intervention with gold standard |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyotonPRO | Device | MyotonPRO measurements of the biomechanical properties of facial mimic muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle tone (Hz) | Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| stiffness (N/m) | Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| elasticity (Logarithmic decrement) | Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Blythe, FRCS | European Face Centre, Universitair Ziekenhuis Brussel and University of Southhampton | Principal Investigator |
| Maurice Mommaerts, Prof.Dr.Mult | European Face Centre, Universitair Ziekenhuis Brussel | Study Chair |
| Daniel Labbé, MD | Saint Martin Private Hospital Caen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Jette | Brussels Capital | 1090 | Belgium |
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| ID | Term |
|---|---|
| D020330 | Bell Palsy |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| non-invasive electromyography (EMG) | Device | Gold standard technique for measuring muscle |
|
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005155 | Facial Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |