NCT04798183

Geometrical Facial Deformation According to Posture in Amyotrophic Lateral Sclerosis

Completed Results posted Last updated 25 November 2024

What this trial tests

trial testing 3-dimensional scan in Amyotrophic Lateral Sclerosis in 28 participants. Completed in 30 April 2022.

Timeline

1 March 2021

Primary endpoint
15 April 2021

30 April 2022

Quick facts

Lead sponsor	Pusan National University Yangsan Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	28
Start date	1 March 2021
Primary completion	15 April 2021
Estimated completion	30 April 2022
Sites	1 location across South Korea

Drugs / interventions tested

• 3-dimensional scan

Conditions studied

• Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Pusan National University Yangsan Hospital

Who can join

Adults 16 to 60, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Amounts of Change of Landmarks Position According to Posture Primary · 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 prome

movement of landmarks according to postural change from sitting to supine

Group	Value	95% CI
Healthy Participants	1.0	± 0.9
Bulbar ALS	2.4	± 2.2

movement of landmarks according to postural change from sitting to lateral decubitus

Group	Value	95% CI
Healthy Participants	2.9	± 1.4
Bulbar ALS	5.6	± 3.2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Postural Facial Deformation of Patients With Bulbar Amyotrophic Lateral Sclerosis and Virtual Fit of Noninvasive Ventilation Mask.
   Jung H, Kim SY, Cui X, Lee W, et al · · 2023 · PMID 36414273 · DOI 10.4187/respcare.10055