N/A
N=28
Geometrical Facial Deformation According to Posture in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT04798183 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: The Amounts of Change of Landmarks Position According to Posture — 1.0; 2.4; 2.9; 5.6 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 3-dimensional scan (Diagnostic_test)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Pusan National University Yangsan Hospital
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Amounts of Change of Landmarks Position According to Posture |
1.0; 2.4; 2.9; 5.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04798183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.