Geometrical Facial Deformation According to Posture in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798183
• Other study ID #: 05-2021-034
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: March 2021
• Source: Pusan National University Yangsan Hospital
• Contact: Sungchul Huh, MD
• Phone: +82-10-9354-2177
• Email: dr.huhsc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 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

2. Healthy volunteer

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

Exclusion Criteria:

1. Patient

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

2. Healthy volunteer

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• 3-dimensional scan
Facial 3-dimensional scan according to posture

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongnam

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial deformation according to posture		1 minute