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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Both Metabolic and Functional Effects Induced by Two Neuromuscular Electrical Stimulation Protocols: A Comprehensive Approach Using Magnetic Resonance Imaging and Spectroscopy

NCT02001675

Healthy

UNKNOWN NA

Towards Restoring Complex Movement After Paralysis: Algorithm Development With Healthy Participants

NCT07236892

Movement Disorders Neurorehabilitation Non-invasive Activity Recording

RECRUITING NA

Use of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.

NCT03721861

Spinal Cord Injuries

TERMINATED NA

Prediction of Muscle Responsiveness to FES Therapy

NCT05462925

Spinal Cord Injury Cervical

COMPLETED NA

Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients

NCT05415514

Paralysis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Facial Nerve Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MyotonPRO

Experimental: Measurement of biomechanical properties of mimic muscles on the ipsilateral palsy side with the healthy contralateral side ( case - control design)

Group Type EXPERIMENTAL

MyotonPRO

Intervention Type DEVICE

MyotonPRO measurements of the biomechanical properties of facial mimic muscles

non-invasive electromyography (EMG)

Intervention Type DEVICE

Gold standard technique for measuring muscle

Non-invasive electromyography (EMG)

Comparing experimental intervention with gold standard

Group Type ACTIVE_COMPARATOR

MyotonPRO

Intervention Type DEVICE

MyotonPRO measurements of the biomechanical properties of facial mimic muscles

non-invasive electromyography (EMG)

Intervention Type DEVICE

Gold standard technique for measuring muscle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MyotonPRO

MyotonPRO measurements of the biomechanical properties of facial mimic muscles

Intervention Type DEVICE

non-invasive electromyography (EMG)

Gold standard technique for measuring muscle

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. unilateral peripheral facial nerve palsy
2. Mental capacity to give consent
3. The patient is able to sit independently

Exclusion Criteria

1. Adults who have undertaken strenuous exercise within the last twenty-four hours
2. 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)
3. Adults with poor mobility (unable to lie prone).
4. Adults with a body mass index (BMI) \>30 kg/m2 . Muscle measurements may be inaccurate with excessive subcutaneous tissue

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes