| CTRI Number |
CTRI/2025/04/085375 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Analytical study |
| Study Design |
Other |
|
Public Title of Study
|
NIL |
|
Scientific Title of Study
|
Assessment of Facial Asymmetry in people with Bell’s Palsy Using Triangulation photogrammetry based Artificial Intelligence- A Prospective Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Birajdar |
| Designation |
Post Graduate |
| Affiliation |
Department of Physiotherapy, Kasturba Medical College, Mangalore, |
| Address |
Department of Physiotherapy, Kasturba Medical College,
Mangalore, Centre for Basic Sciences, Bejai, Mangalore –
dakshina kannada karnataka
575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9112406933 |
| Fax |
|
| Email |
birajdarrohanbvc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abraham M Joshua |
| Designation |
Additional professor |
| Affiliation |
Department of Physiotherapy, Kasturba Medical College, Mangalore, |
| Address |
Department of Physiotherapy, Kasturba Medical College, Mangalore, Centre for Basic Sciences, Bejai, Mangalore –
dakshina kannada karnataka
575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9886188221 |
| Fax |
|
| Email |
abraham.joshua@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abraham M Joshua |
| Designation |
Additional professor |
| Affiliation |
Department of Physiotherapy, Kasturba Medical College, Mangalore, |
| Address |
Department of Physiotherapy, Kasturba Medical College, Mangalore, Centre for Basic Sciences, Bejai, Mangalore –
dakshina kannada karnataka
575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9886188221 |
| Fax |
|
| Email |
abraham.joshua@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rohan Birajdar |
| Address |
Department of Physiotherapy, Kasturba Medical College, Mangalore, Centre for Basic Sciences, Bejai, Mangalore – 575004 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAbraham M Joshua |
Kasturba Medical College, Mangalore. |
Department of Physiotherapy,5th floor, B.R Ambedkar circle,Hampankatta,Mangaluru, Karnataka.575001
Dakshina Kannada
KARNATAKA |
9886188221
abraham.joshua@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteeKasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
AGE AND GENDER MATCHED INDIVIDUALS |
| Patients |
(1) ICD-10 Condition: G510||Bells palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with Bell’s Palsy in acute stages to subacute in the age group 18 and above.
Age and gender-matched subjects without facial palsy.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with facial asymmetry arising from causes other than Bell’s palsy.
2. Subjects with other neurological conditions
3. Subjects with facial trauma and UMN facial palsy.
4. Subjects with asymmetric loss of dentation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The data generated based on photogrammetry at various stages of Bell’s palsy prognosis will be used to train artificial intelligence to identify asymmetry and estimate its degree of severity. The photogrammetry data collected from normal subjects will be used as a comparator for training the AI. |
The data generated based on photogrammetry at various stages of Bell’s palsy prognosis will be used to train artificial intelligence to identify asymmetry and estimate its degree of severity. The photogrammetry data collected from normal subjects will be used as a comparator for training the AI. The procedure will be carried out twice, on the day of enrolment to the study (0) and after completion of the 4th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The data generated based on photogrammetry at various stages of Bell’s palsy prognosis will be used to train artificial intelligence to identify asymmetry & estimate its degree of severity. The photogrammetry data collected from normal subjects will be used as a comparator for training the AI. The procedure will be carried out twice, on the day of enrolment to the study (0) & after completion of the 4th week. |
for healthy individuals once |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM
OF THE STUDY:
To Assess Facial Asymmetry in people with Bell’s Palsy Using Triangulation
photogrammetry based Artificial Intelligence.
OBJECTIVES OF STUDY:
1.
To use Triangulation-based photogrammetry techniques for detailed 2D modeling of facial
asymmetry in people with Bell’s palsy.
2.
To
Train AI with data of Triangulation-based photogrammetry to capture both static and dynamic asymmetry
accurately. |