Clinical Trials Directory

Trials / Completed

CompletedNCT02489162

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Universitair Ziekenhuis Brussel · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

Detailed description

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

Conditions

Interventions

TypeNameDescription
DEVICEMyotonPROMyotonPRO measurements of the biomechanical properties of facial mimic muscles
DEVICEnon-invasive electromyography (EMG)Gold standard technique for measuring muscle

Timeline

Start date
2015-09-01
Primary completion
2018-12-01
Completion
2019-04-01
First posted
2015-07-02
Last updated
2025-11-18

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02489162. Inclusion in this directory is not an endorsement.