Geometrical Facial Deformation According to Posture in Amyotrophic Lateral Sclerosis

Sponsor

Pusan National University Yangsan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04798183

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis	Diagnostic Test: 3-dimensional scan

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Apr 15, 2021

Anticipated Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Healthy participants	Diagnostic Test: 3-dimensional scan Facial 3-dimensional scan according to posture
Amyotrophic Lateral Sclerosis with bulbar involvement patients	Diagnostic Test: 3-dimensional scan Facial 3-dimensional scan according to posture

Arm

Intervention/Treatment

Healthy participants

Diagnostic Test: 3-dimensional scan

Facial 3-dimensional scan according to posture

Amyotrophic Lateral Sclerosis with bulbar involvement patients

Diagnostic Test: 3-dimensional scan

Facial 3-dimensional scan according to posture

Outcome Measures

Primary Outcome Measures

Facial deformation according to posture [1 minute]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Yangsan Hospital	Yangsan	Gyeongnam	Korea, Republic of	50612

Sponsors and Collaborators

Pusan National University Yangsan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sungchul Huh, Medical doctor, Pusan National University Yangsan Hospital

ClinicalTrials.gov Identifier:

NCT04798183

Other Study ID Numbers:

05-2021-034

First Posted:

Mar 15, 2021

Last Update Posted:

Mar 15, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Motor Neuron Disease

Amyotrophic Lateral Sclerosis

Sclerosis

Study Results

No Results Posted as of Mar 15, 2021