Geometrical Facial Deformation According to Posture in Amyotrophic Lateral Sclerosis

The measurement of the facial deformation according to the body posture will be conducted by 3D scanning for each posture after marking the landmarks on the face. A 3D scan of the face will be conducted for 1 minute in a static state for the sitting posture to be used as a reference, the supine posture to gaze at the ceiling while lying down correctly, and the lateral posture to the side with the upper body facing left. Healthy volunteer and ALS with bulbar palsy participants will be asked to keep their mouths closed gently while the 3D scan was being processed. A post-processing of the 3D face scan data will be conducted to analyze facial deformation by the body postures. A facial deformation will be analyzed by measuring the amount of change in position for each reference point after aligning and rotating the facial data on the same basis. The relative ratio of the amount of position change to the size of the face will be analyzed. The present study will analyze the effect of the body posture on the position changes of the landmarks.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

About this study

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that eventually affects the respiratory muscles. In most cases of the slow progression of respiratory failure, noninvasive ventilation (NIV) is the first treatment option. NIV treatment provides a better quality of life and is, therefore, strongly recommended; however, its use must consider the type of ALS. Severe bulbar dysfunction limits NIV treatment. Aside from additional NIV options in ALS, including mouthpiece ventilation and intermittent abdominal pressure ventilation, prolonged use of a ready-made face mask is impractical for several reasons. Cognitive impairments can affect the maintenance of NIV. Hypersalivation and bronchial secretion disrupting ventilation can lead to poor NIV adherence. Pressure injuries are another clinical issue. The incidence of pressure injuries associated with NIV masks ranges from 10-31%. Long-term use of NIV face masks can result in pressure injuries at the contact area, and skin-protective patches may not prevent skin problems. Patients with bulbar ALS frequently have postural facial deformations, and these can lead to difficulties in wearing the NIV mask.

The aim of this study was to compare the deformations of the face in different postures in subjects with bulbar ALS and healthy participants. This study also virtually fitted an NIV mask to understand how the NIV mask interface affects the face in different postures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient

a patient with Amyotrophic Lateral Sclerosis over 16 years
a patient with respiratory difficulty
a patient who requires or anticipates mechanical ventilation
a patient who visit out- or inpatient clinic at rehabilitation hospital
Healthy volunteer

a volunteer without history of facial surgery or neuromuscular disease
a volunteer without respiratory difficulty

Exclusion criteria

Patient

a patient who cannot scan due to respiratory instability
a patient who cannot bear posture for 3D scanning
Healthy volunteer

a volunteer with neuromuscular disease
a volunteer with history of facial surgery or palsy

Treatment and study plan

3-dimensional scan

Diagnostic Test

Facial 3-dimensional scan according to posture

Primary outcomes

The Amounts of Change of Landmarks Position According to Posture

Time frame: 1 minute

The primary outcome measure is the change in position of anatomical landmarks, quantified using millimeter measurements in the anteroposterior and lateral directions. Change is reported as the mean displacement (mm) during the change in position from the initial position (sitting) to the subsequent position (supine & side-lying). Ten anatomical landmarks were located in the nasal root area for 4 points (sellion, glabella, left dacryon, and right dacryon) and in the oral area for 6 points (subnasale, SN; labial superius, LS; labial inferius, LI; cheilion left, CL; cheilion right, CR; and promentale, PM)

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Geometrical Facial Deformation According to Posture and Non-invasive Ventilation Mask Virtual Fit in Amyotrophic Lateral Sclerosis

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Mar 15, 2021
Registry last updated: Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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