We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Geometrical Facial Deformation According to Posture in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04798183
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Sungchul Huh, Pusan National University Yangsan Hospital

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
Amyotrophic Lateral Sclerosis Diagnostic Test: 3-dimensional scan

Layout table for study information
Study Type : Observational
Estimated 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 : March 1, 2021
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : April 30, 2021


Group/Cohort 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




Primary Outcome Measures :
  1. Facial deformation according to posture [ Time Frame: 1 minute ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patient: a patient who visit out- or inpatient clinic at rehabilitation hospital Healthy volunteer: community dwelling volunteer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04798183


Contacts
Layout table for location contacts
Contact: Sungchul Huh, MD +82-10-9354-2177 dr.huhsc@gmail.com

Locations
Layout table for location information
Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan, Gyeongnam, Korea, Republic of, 50612
Contact: Sungchul Huh, MD    +82-10-9354-2177    dr.huhsc@gmail.com   
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Layout table for additonal information
Responsible Party: Sungchul Huh, Medical doctor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT04798183    
Other Study ID Numbers: 05-2021-034
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases