| CTRI Number |
CTRI/2025/07/090516 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Neural mobilization in bells palsy |
|
Scientific Title of Study
|
Unveiling the neurodynamics solution: The comparative study of neural mobilization along electrical stimulation versus mime therapy along electrical stimulation in Bells palsy |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunselvan.D |
| Designation |
PG -Student |
| Affiliation |
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES |
| Address |
Department of neurology physiotherapy ,SRIPMS
395,sarojni naidu rd,
siddhapudur,new siddhapudur,
coimbatore,tamilnadu
Coimbatore
TAMIL NADU
1
India |
| Phone |
8608414979 |
| Fax |
|
| Email |
arunselvan952@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Porkodi.R |
| Designation |
Professor |
| Affiliation |
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES |
| Address |
Fourth floor,Department of physiotherapy,SRIPMS
395,sarojni naidu rd,
siddhapudur,new siddhapudur,
coimbatore,tamilnadu
Coimbatore
TAMIL NADU
1
India |
| Phone |
9443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Porkodi.R |
| Designation |
Professor |
| Affiliation |
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES |
| Address |
Fourth floor ,HEAD OF PHYSIOTHERAPYDEPARTMENT,
SRIPMS
395,sarojni naidu rd,
siddhapudur,new siddhapudur,
coimbatore,tamilnadu
Coimbatore
TAMIL NADU
1
India |
| Phone |
9443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of physiotherapy ,Sri ramakrishna institute of paramedical and sciences ,Tamilnadu, coimbatore ,India ,641044 |
|
|
Primary Sponsor
|
| Name |
Arunselvan D |
| Address |
395,sarojni naidu rd,
siddhapudur,new siddhapudur,
coimbatore,tamilnadu, 641044 |
| 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 |
| DrRPorkodi |
Sri ramakrishna multi speciality hospital |
Fourth floor ,DEPARTMENT OF PHYSIOTHERAPY,
395,sarojni naidu rd,
siddhapudur,new siddhapudur,
coimbatore,tamilnadu, 641044.
Coimbatore
TAMIL NADU |
9443820164
porkodi.mpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRISHNA HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
bells palsy condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A :Neural mobilization along electrical stimulation.
Group B : MIME therapy along electrical stimulation |
6 months |
| Comparator Agent |
neural mobilization along electrical stimulation and MIME therapy along electrical stimulation |
6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.frist time bells palsy
2.bells palsy due to nerve compression (cold air exposure)
3.willing to participate
4.unilateral bells palsy |
|
| ExclusionCriteria |
| Details |
Facial palsy.
Patient with pervious history peripheral facial paralysis.
Supranuclear lesion or any known cause of infection.
Any open wound or ulcer over face.
Any traumatic face injury.
Non cooperative patients.
After any surgery of dental , ear , nose , and throat.
Central nerve system tumour.
Patients with Stroke.
Other causes excluded.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified house brockmann scale |
1 Week & 4 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kineo movement analaysis software |
1 Week & 4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
14/07/2025 |
| 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="0"
Months="6"
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
|
Therefore , they short term is reduce a inflammation of the facial nerve and improve facial symmetry and long term is improve facial expression, improve speech clarity , restore eye closure ability ,reduce severity facial paralysis, improve quality of life. |