The Role of a Device to Evaluate the Neuromuscular Function in Assessing Muscle in Facial Paralysis Patients
MyotonPRO
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
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
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
First Submitted
Initial submission to the registry
June 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedNovember 18, 2025
October 1, 2018
3.3 years
June 10, 2015
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Muscle tone (Hz)
Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.
12 months
Secondary Outcomes (1)
stiffness (N/m)
12 months
Other Outcomes (1)
elasticity (Logarithmic decrement)
12 months
Study Arms (2)
MyotonPRO
EXPERIMENTALExperimental: 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 COMPARATORComparing experimental intervention with gold standard
Interventions
MyotonPRO measurements of the biomechanical properties of facial mimic muscles
Gold standard technique for measuring muscle
Eligibility Criteria
You may qualify if:
- unilateral peripheral facial nerve palsy
- Mental capacity to give consent
- The patient is able to sit independently
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Blythe, FRCS
European Face Centre, Universitair Ziekenhuis Brussel and University of Southhampton
- STUDY CHAIR
Maurice Mommaerts, Prof.Dr.Mult
European Face Centre, Universitair Ziekenhuis Brussel
- STUDY DIRECTOR
Daniel Labbé, MD
Saint Martin Private Hospital Caen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2015
First Posted
July 2, 2015
Study Start
September 1, 2015
Primary Completion
December 1, 2018
Study Completion
April 1, 2019
Last Updated
November 18, 2025
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share