| CTRI Number |
CTRI/2026/03/106763 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
A Single group Pre-post Assessment study |
| Study Design |
Other |
|
Public Title of Study
|
A single group pre and post assessment study looked at the effects of targeted physical therapy on facial function and social anxiety in people with Bells palsy. |
|
Scientific Title of Study
|
Effect of targeted physical therapy interventions on facial function and social anxiety in subjects with Bells palsy: A single group pre-post assessment 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 |
Lekhana Surada |
| Designation |
Researcher |
| Affiliation |
Gitam institute of Medical Sciences and Research, Gitam school of physiotherapy |
| Address |
4th floor, Gitam school of physiotherapy, GIMSR college building, GIMSR campus, Rushikonda, Visakhapatnam-530045, Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530045 India |
| Phone |
09703870116 |
| Fax |
|
| Email |
suradalekhana@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Srinadh Katragadda |
| Designation |
Assistant Professor |
| Affiliation |
Gitam institute of Medical Sciences and Research, Gitam school of physiotherapy |
| Address |
4th floor, Gitam school of physiotherapy, GIMSR college building, GIMSR campus, Rushikonda, Visakhapatnam-530045, Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530045 India |
| Phone |
9618552526 |
| Fax |
|
| Email |
skatradg@gitam.edu |
|
Details of Contact Person Public Query
|
| Name |
Srinadh Katragadda |
| Designation |
Assistant Professor |
| Affiliation |
Gitam institute of Medical Sciences and Research, Gitam school of physiotherapy |
| Address |
4th floor, Gitam school of physiotherapy, GIMSR college building, GIMSR campus, Rushikonda, Visakhapatnam-530045, Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530045 India |
| Phone |
9618552526 |
| Fax |
|
| Email |
skatradg@gitam.edu |
|
|
Source of Monetary or Material Support
|
| Gitam Institute of Medical Sciences and Research Hospital, GIMSR campus, Rushikonda, Visakhapatnam - 530045, Andhra Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
Lekhana Surada |
| Address |
4th floor, Gitam School of Physiotherapy, GIMSR Campus, Rushikonda, Visakhapatnam, pincode- 530045,Andhra Pradesh, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Srinadh Katragadda PT |
GIMSR Hospital |
Room no 1, Physiotherapy OPD, Gitam Institute of Medical Sciences and Research Campus, Rushikonda, Visakhapatnam. Visakhapatnam ANDHRA PRADESH |
9618552526
skatradg@gitam.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gitam institute of Medical Sciences and Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G510||Bells palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who diagnosed with Bell’s palsy( LMN) by clinician.
patients who give their consent.
Unilateral Bell’s Palsy.
|
|
| ExclusionCriteria |
| Details |
Cognitive impairment (MMSE Score less than 23)
UMN type facial paralysis.
People who have underlying psychiatric conditions.
Neoplasms.
Patients undergoing radiotherapy or chemotherapy
Patients with progressive diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sunny Brook Facial Grading System.
Social Appearance Anxiety Scale.
|
Pre evaluation on 1st day of the treatment, post evaluation on last day of the treatment and short-term follow up after 1 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mini Mental State Examination. |
Pre evaluation on 1st day of the treatment, post evaluation on last day of the treatment and short-term follow up after 1 month. |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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)
|
01/04/2026 |
| 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="0" 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
|
In patients with facial paralysis, the health-related quality of life (HRQOL) is affected not only due to impaired facial function but also due to altered mental and social well-being. So the treatment strategy for patients with Bell’s palsy should focus on both physical and psychosocial issues. Physical therapy primarily focuses on physical and functional recovery in patients with Bell’s palsy, but there are only limited studies focusing on the effect of physical therapy on social anxiety. The need of the study is to know whether the physical therapy intervention has a dual effect on improving facial function and lowering social anxiety in patients with Bell’s palsy. |