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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

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.

Detailed Summary: 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
Sponsor: Universitair Ziekenhuis Brussel

Current Primary Outcome: Muscle tone (Hz) [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: stiffness (N/m) [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: Universitair Ziekenhuis Brussel

Dates:
Date Received: June 10, 2015
Date Started: August 2015
Date Completion: July 2017
Last Updated: August 16, 2016
Last Verified: August 2016